NCBO Wiki - User contributions [en]

Action items from 05/10/07 call

2007-05-10T18:49:28Z

Jalee:

Go back to [[CTO:Main Page]]

'''Action Items to be completed for CTO workshop:'''
* Simona, Cristain, others will come up with some good use cases for the CTO. Ask Alan Ruttenberg for use case
* Create a new OWL file for the CTO and import OBI into this file (Trish/Jamie)
* Work on fleshing out CTO branches. Don't worry about too much detail. Just a couple levels down from the main term will be sufficient to illustrate the direction we are going in.
** Jim - Study design
** Simona - Roles
** Richard/Jamie - Protocol
* Deadline for getting branches into the CTO OWL file is COB Monday, May 14. Remember to follow Check-out policy for OWL file.
* Generate some graphics of the main branches and how they fit into the OBI for the CTO workshop presentation (Jamie)

'''Other Action Items:'''
* Summary descriptions and re-organization of the various term lists on the wiki (Jamie)

Minutes from 05/10/07 Conference Call

2007-05-10T18:32:39Z

Jalee:

Go back to [[CTO:Main Page]]

Attendees: Barry, Trish, Simona, Jim, Cristian, Richard, Jamie

Meeting Minutes:

* Use Cases for the CTO - why do we need an ontology rather than simply a structured vocabulary like the CDISC glossary?
** useful for software to be able to convert hospital documents such that they are compatible with a data standard to facilitate things like submission to FDA, global clinical research, etc
** to encourage annotation of data and enable reliable retrieval and query
** to enable software to structure how information is provided in clinical report forms
** to be able to identify clinical trials based on the attributes they are annotated with (like the Gene Ontology)
** to facilitate communications between clinical trials investigators and software/equipment vendors in making custom changes to equipment during the course of a clinical trial
** to standardize terminology across the clinical trial domain

* Evaluation for work done over past week
** we need to merge term lists, map synonyms, split terms with multiple definitions
** we need a summary description of each of the term lists on the wiki, and they should be better organized
** draft placement of terms into various OBI categories is a great start and a great indication of the kind of progress we have made. We need to further evaluate these placements and determine whether there are fundamental changes that need to be made to OBI (such as "object aggregates" of people with the role "population" rather than "population" as a child of "object aggregate"
** Other examples: a drug should really be a chemical that plays the role of "drug" or "treatment", etc.
** We should split up main branches and have certain people focus on a single branch in order to avoid overlap in ontology development
** We should approach both a top-down and a bottom-up approach in development. By taking our initial term lists, we can determine the major CTO branches and begin working on individual branches
** We should start positioning terms in Protege and adhere to our check-out policy for working on the OWL file
** We should import OBI into a new CTO OWL file in order to keep OBI/BFO terms uneditable. Any proposed edits to OBI should be done within the OBI itself. Simona will compile our list of question for OBI on term placement. Trish/Jamie will work on generating the CTO OWL file with OBI imported

* CTO Branches (volunteers)
** Jim - Study design
** Simona - Roles
** Richard/Jamie - Protocol

* CTO workshop
** Presentation at workshop will be focused on our development process and rationale
** We need to generate graphics of the major CTO branches and how they are integrated into the OBI
** Deadline for work done on branches in the CTO OWL file is COB on Monday, May 14. Jamie will generate graphs based on this OWL file

Minutes from 05/10/07 Conference Call

2007-05-10T18:31:58Z

Jalee:

Attendees: Barry, Trish, Simona, Jim, Cristian, Richard, Jamie

Meeting Minutes:

* Use Cases for the CTO - why do we need an ontology rather than simply a structured vocabulary like the CDISC glossary?
** useful for software to be able to convert hospital documents such that they are compatible with a data standard to facilitate things like submission to FDA, global clinical research, etc
** to encourage annotation of data and enable reliable retrieval and query
** to enable software to structure how information is provided in clinical report forms
** to be able to identify clinical trials based on the attributes they are annotated with (like the Gene Ontology)
** to facilitate communications between clinical trials investigators and software/equipment vendors in making custom changes to equipment during the course of a clinical trial
** to standardize terminology across the clinical trial domain

* Evaluation for work done over past week
** we need to merge term lists, map synonyms, split terms with multiple definitions
** we need a summary description of each of the term lists on the wiki, and they should be better organized
** draft placement of terms into various OBI categories is a great start and a great indication of the kind of progress we have made. We need to further evaluate these placements and determine whether there are fundamental changes that need to be made to OBI (such as "object aggregates" of people with the role "population" rather than "population" as a child of "object aggregate"
** Other examples: a drug should really be a chemical that plays the role of "drug" or "treatment", etc.
** We should split up main branches and have certain people focus on a single branch in order to avoid overlap in ontology development
** We should approach both a top-down and a bottom-up approach in development. By taking our initial term lists, we can determine the major CTO branches and begin working on individual branches
** We should start positioning terms in Protege and adhere to our check-out policy for working on the OWL file
** We should import OBI into a new CTO OWL file in order to keep OBI/BFO terms uneditable. Any proposed edits to OBI should be done within the OBI itself. Simona will compile our list of question for OBI on term placement. Trish/Jamie will work on generating the CTO OWL file with OBI imported

* CTO Branches (volunteers)
** Jim - Study design
** Simona - Roles
** Richard/Jamie - Protocol

* CTO workshop
** Presentation at workshop will be focused on our development process and rationale
** We need to generate graphics of the major CTO branches and how they are integrated into the OBI
** Deadline for work done on branches in the CTO OWL file is COB on Monday, May 14. Jamie will generate graphs based on this OWL file

Action items from 05/10/07 call

2007-05-10T17:12:41Z

Jalee: New page: coming soon

coming soon

Action Items

2007-05-10T17:12:09Z

Jalee:

Go back to [[CTO:Main Page]]

*[[Action items from 05/10/07 call]]
*[[Action items from 05/03/07 call]]
*[[Action items from 04/19/07 call]]

Minutes from 05/10/07 Conference Call

2007-05-10T17:11:27Z

Jalee: New page: coming soon

coming soon

Conference Call Minutes

2007-05-10T17:11:07Z

Jalee:

Go back to [[CTO:Main Page]]

* [[Minutes from 05/10/07 Conference Call]]
* [[Minutes from 05/03/07 Conference Call]]
* [[Minutes from 04/19/07 Conference Call]]
* [[Minutes from 04/12/07 Conference Call]]

Conference Call Agendas

2007-05-10T13:58:04Z

Jalee:

Go back to [[CTO:Main Page]]

= Conference Call Agendas =

==May 10==
1. Review the recent work that several people have added 
2. Review the goals and organization of the workshop 
3. Discuss how we think the CTO could be useful (use cases) 

==May 3==
*Discussion of High-Level BFO-OBI Structure
*Discussion of new added terms
*Plans for CTO Workshop
*Action items for the coming week

==April 19==
'''1. Ontology of Biomedical Investigation'''
*a. Overview of OBI core (Fostel, tentative)
'''2. CTO development approach (with deadlines and milestones)'''
*a. Goals for completion by May16th
*b. Status of proposed steps
**term list assembly
**term list merging
**term positioning into branches
**term CTO definition
'''3. High-level concept branches'''

'''4. Others'''

==April 12==
'''1. CTO Working Group (WG) Organization'''
*a. Are current assignments acceptable?
*b. Need a secretary
*c. Responsibilities
*d. Schedule of calls
'''2. Development and WG policies in general'''
*a. Draft metadata and CTO check-out policies
*b. CTO WG membership policy
'''3. Ontology Organization'''
*a. Relationship with the BFO
*b. Relationship with the OBI
'''4. CTO scope'''
*a. Definition of the CTO domain
*b. Relationship with other ontologies
'''5. CTO development approach (with deadlines and milestones)'''
*a. Proposed steps
**term list assembly
**term list merging
**term positioning into branches
**term CTO definition
*b. Goals for completion by May 16th
*c. Managing discussion threads
'''6. Information objects as dependent continuants (if time)'''

OCI Term Compilation (Jennifer)

2007-05-09T20:46:51Z

Jalee:

Go back to [[CTO:Main Page]]

Term lists contributed by Jennifer:
* Download May 3, 2007 term list here: [[Image:CTO-may3.xls]]
* Download May 9, 2007 term list here: [[Image:CTO-terms-wAllCDISCglossary.xls]]

Some notes from Simona on the RCT terms as classified in the May 3 term list:
[[Image:CTO-may3-RCT.xls]]

May 9, 2007 term list shown below:

{| {{table}}
| align="center" style="background:#f0f0f0;"|'''source'''
| align="center" style="background:#f0f0f0;"|'''draft category'''
| align="center" style="background:#f0f0f0;"|'''term / definition'''
|-
| CDISCglossary||format||“adequate and well-controlled study”see 21CFR 314.126.
|-
| CDISCglossary||pharmacokinetics||absorption.
|-
| CDISCglossary||documents||action letter.
|-
| CDISCglossary||protocol||activation. event when an eClinical trial system is enabled for capturing data,
|-
| CDISCglossary||protocol||admission criteria.
|-
| CDISCglossary||unshceduled event||adverse drug experience. See adverse drug reaction.
|-
| CDISCglossary||unshceduled event||adverse drug reaction (ADR)
|-
| CDISCglossary||unshceduled event||adverse event (AE). Synonyms: side effect, adverse experience.
|-
| CDISCglossary||protocol||algorithm.
|-
| CDISCglossary||statistics||alpha error.
|-
| CDISCglossary||documents||amendment.
|-
| CDISCglossary||organization||American National Standards Institute (ANSI)
|-
| CDISCglossary||role||analysis set. A set of subjects whose data are to be included in the main analyses.
|-
| CDISCglossary||other||analysis variables.
|-
| CDISCglossary||computer||applet. A small application, typically downloaded from a server.
|-
| CDISCglossary||computer||application. 1. Computer application; 2. Regulatory application:
|-
| CDISCglossary||documents||application. 1. Computer application; 2. Regulatory application:
|-
| CDISCglossary||documents||application. 1. Computer application; 2. Regulatory application:
|-
| CDISCglossary||documents||approvable letter
|-
| CDISCglossary||protocol||approval
|-
| CDISCglossary||documents||approval letter,
|-
| CDISCglossary||documents||approval letter. An official communication from FDA
|-
| CDISCglossary||time||arm. A planned sequence of elements, typically equivalent to a treatment group. [SDTM]
|-
| CDISCglossary||protocol||assessment. A measurement, evaluation or judgment.
|-
| CDISCglossary||protocol||audit
|-
| CDISCglossary||documents||audit certificate
|-
| CDISCglossary||documents||audit report
|-
| CDISCglossary||data||audit trail
|-
| CDISCglossary||documents||background material.
|-
| CDISCglossary||statistics||balanced study.
|-
| CDISCglossary||property||bandwidth
|-
| CDISCglossary||protocol||baseline assessment
|-
| CDISCglossary||data||baseline characteristics. Data collected for each participant at the beginning
|-
| CDISCglossary||property||baseline imbalance. Systematic error in creating intervention groups
|-
| CDISCglossary||statistics||Bayesian approaches.
|-
| CDISCglossary||statistics||beta error.
|-
| CDISCglossary||statistics||bias.
|-
| CDISCglossary||protocol||bioanalytical assays. Methods for quantitative measurement of a drug, enzyme
|-
| CDISCglossary||pharmacokinetics||bioavailability. Rate and extent to which a drug is absorbed
|-
| CDISCglossary||pharmacokinetics||bioequivalence. Scientific basis on which drugs with the same active ingredient(s) are compared.
|-
| CDISCglossary||role||biological marker. See biomarker.
|-
| CDISCglossary||documents||Biologics Licensing Application (BLA). An application to FDA for a license to market
|-
| CDISCglossary||role||biomarker. A characteristic that is objectively measured and evaluated as
|-
| CDISCglossary||statistics||biostatistics. Branch of statistics applied to the analysis of biological phenomena.
|-
| CDISCglossary||protocol||blind review. Checking and assessing data prior to breaking the blind, for the purpose of
|-
| CDISCglossary||role||blinded (masked) medications. Products that appear identical in size,
|-
| CDISCglossary||study||blinded study. A study in which is unaware of the treatment assignment
|-
| CDISCglossary||protocol||blinding. Preventing identification of treatments/procedures/test to test. Masking, while often used synonymously with blinding, is usually associated with concealing the specific study intervention used. The term “masking” is often preferred in the field of ophthalmology.
|-
| CDISCglossary||property||brand name. See proprietary name. Synonyms: trade name; proprietary
|-
| CDISCglossary||computer||browser. Computer program that runs on the user’s desktop computer
|-
| CDISCglossary||computer||cache. Storage area on a computer’s hard drive where the browser stores
|-
| CDISCglossary||property||carry-over effect. Effects of treatment that persist after treatment has been stopped,
|-
| CDISCglossary||document||case history. An adequate and accurate record prepared and
|-
| CDISCglossary||document||case record form. See case report form.
|-
| CDISCglossary||document||case report form (CRF document designed to record all of the required information to be reported to the sponsor for each trial subject.
|-
| CDISCglossary||data||case report form 2. A record of clinical study observations and other information that a study
|-
| CDISCglossary||document||case report tabulations (CRT). In a paper submission, listings of data. See also eCRT.
|-
| CDISCglossary||data||categorical data. Data evaluated by sorting values (for example, severe,
|-
| CDISCglossary||data||causality assessment. An evaluation performed by a medical professional
|-
| CDISCglossary||ethics committee||CCI committee on clinical investigations
|-
| CDISCglossary||ethics committee||CCPPRB Comité Consultative pour la Protection des Personnes dans les
|-
| CDISCglossary||format||CDISC Standard (The). CDISC term for a proposed uniform CDISC standard intended to address the full life-cycle of a clinical trial including protocol representation, capture of source data, submission and archiving using a set of derived from the current set of CDISC standards.
|-
| CDISCglossary||document||certified copy
|-
| CDISCglossary||person role||Certified IRB Professional (CIP).
|-
| CDISCglossary||ethics committee||CHR committee on human research
|-
| CDISCglossary||data||clean database. A set of reviewed
|-
| CDISCglossary||computer||client. A program that makes a
|-
| CDISCglossary||quality||clinical benefit.
|-
| CDISCglossary||data / document||clinical clarification. A query resolution from the sponsor See also self-evident change.
|-
| CDISCglossary||data||clinical data. Data pertaining to the medical well-being or status of a subject.
|-
| CDISCglossary||document||clinical development plan. document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, NOTE: the plan should have appropriate decision points and allow modification as knowledge accumulates.
|-
| CDISCglossary||format||clinical document architecture. Specification for the structure and semantics for the purpose of exchange.
|-
| CDISCglossary||document||clinical document. A documentation of clinical observations and services.
|-
| CDISCglossary||other||clinical efficacy.
|-
| CDISCglossary||investigation||clinical investigation. See clinical trial.
|-
| CDISCglossary||science||clinical pharmacology.
|-
| CDISCglossary||protocol||clinical protocol. See protocol.
|-
| CDISCglossary||science||clinical research and development. The testing of a drug compound in humans
|-
| CDISCglossary||person role||clinical research associate (CRA).
|-
| CDISCglossary||person role||clinical research coordinator (CRC). handles most of the administrative responsibilities of a clinical trial on behalf of a site Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse.
|-
| CDISCglossary||quality||clinical significance. Change in a subject’s clinical condition regarded as important whether or not due to the test intervention. criteria for clinical significance should be stated in the protocol.
|-
| CDISCglossary||document||clinical study (trial) report. A
|-
| CDISCglossary||investigation||clinical study. See clinical trial.
|-
| CDISCglossary||data||clinical trial data. clinical trial information.
|-
| CDISCglossary||document||clinical trial exemption (CTX). allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA),
|-
| CDISCglossary||data||clinical trial information. Data collected in the course of a clinical trial
|-
| CDISCglossary||investigation||clinical trial. Any investigation in human subjects intended to discover or
|-
| CDISCglossary||data||clinician reported outcome. Clinician assessment of patient outcomes,
|-
| CDISCglossary||format||codelist. Finite list of codes and their meaning
|-
| CDISCglossary||protocol||cognitive debriefing. A tool used to determine whether concepts and items are understood by patients in the same way that PRO instrument developers
|-
| CDISCglossary||study||cohort study. Study of a group of individuals, some of whom are exposed
|-
| CDISCglossary||role / aggregate||cohort. 1. A group of individuals who share a common exposure, experience or characteristic. 2. A group of individuals traced in a cohort study.
|-
| CDISCglossary||property||combination product. 1. A product comprising two or more individual
|-
| CDISCglossary||format||Common Technical Document. A format agreed upon by ICH See also eCTD.
|-
| CDISCglossary||study||comparative study.
|-
| CDISCglossary||organization||Competent Authority (CA). The regulatory body charged with
|-
| CDISCglossary||data||complete file. File for which all data
|-
| CDISCglossary||protocol||completion. 1. Subject completion: 2. Study completion:
|-
| CDISCglossary||protocol||compliance (in relation to
|-
| CDISCglossary||computer||computer application. See application.
|-
| CDISCglossary||statistics||confidence interval.
|-
| CDISCglossary||other||confidentiality. Prevention of
|-
| CDISCglossary||study design||confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
|-
| CDISCglossary||trial||confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
|-
| CDISCglossary||document||consent form. Synonym: informed consent form; see also informedconsent.
|-
| CDISCglossary||person role||consumer safety officer (CSO). FDA official who coordinates the review
|-
| CDISCglossary||organization role||contract research organization
|-
| CDISCglossary||document||contract. A written, dated, and
|-
| CDISCglossary||role||control group. The group of subjects
|-
| CDISCglossary||role||control(s). 1. Comparator against which the study treatment is evaluated
|-
| CDISCglossary||study||controlled study. A study in whicha test article is compared with atreatment that has known effects. The
|-
| CDISCglossary||format||controlled vocabulary. A finite set
|-
| CDISCglossary||computer||controls 2 Computer: processes or operations intended to ensure authenticity, integrity, and confidentiality of electronic records.
|-
| CDISCglossary||role||coordinating committee
|-
| CDISCglossary||person role||coordinating investigator.
|-
| CDISCglossary||statistics||correlation.
|-
| CDISCglossary||other||covariate (prognostic). Factor or condition that influences outcome of a trial.
|-
| CDISCglossary||ethics committee||CPPHS committee for the protection of human subjects
|-
| CDISCglossary||ethics committee||CRB central review board
|-
| CDISCglossary||ducument||CRF (paper). Case report form See also eCRF, case report form.
|-
| CDISCglossary||study||crossover trial. A trial design for which subjects function as their own control
|-
| CDISCglossary||document||curriculum vitae (cv).
|-
| CDISCglossary||protocol||data acquisition. Capture of dataContrast with data entry, electronic data capture.
|-
| CDISCglossary||organization role||data and safety monitoring board (DSMB). See data monitoring committee.
|-
| CDISCglossary||document||data clarification form. A form used to query an investigator and collect feedback to resolve questions
|-
| CDISCglossary||protocol||data clarification. Answer supplied by the investigator in response to a
|-
| CDISCglossary||protocol or document||data collection instrument. A substrate or tool (either electronic or paper) used to record, transcribe orcollect clinical data
|-
| CDISCglossary||computer||data element. 1. For XML, an item
|-
| CDISCglossary||computer||data encryption standard (DES).
|-
| CDISCglossary||protocol||data entry. Human input of data
|-
| CDISCglossary||protocol||data integrity verification. Manual process
|-
| CDISCglossary||data quality||data integrity. An attribute of data
|-
| CDISCglossary||protocol||data interchange. Transfer of data, maintains integrity
|-
| CDISCglossary||data||data item. A named component of adata element. Usually the smallest
|-
| CDISCglossary||protocol||data management conventions.
|-
| CDISCglossary||protocol||data management. Tasks
|-
| CDISCglossary||data||data model. Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use.
|-
| CDISCglossary||organization||data monitoring committee
|-
| CDISCglossary||protocol||data monitoring. Process by which clinical data are examined for completeness, consistency, and accuracy.
|-
| CDISCglossary||data||data quality. Describes the characteristics that confirm “fitness for use”—that is, ability to support auditing. NOTE: Because assessments of data quality are linked to the needs of the study and expectations of the user, the quality criteria may vary from one project to another.
|-
| CDISCglossary||data||data security. Degree to which data are protected from the risk of accidental or malicious alteration or
|-
| CDISCglossary||protocol||data selection criteria. The rules
|-
| CDISCglossary||protocol||data transformations. Algorithmic
|-
| CDISCglossary||data||data type. Data types define the structural format of the data carried in the attribute and influence the set of allowable values an attribute may
|-
| CDISCglossary||protocol||data validation. 2. Process used to determine if data are inaccurate,incomplete, or unreasonable. The process may include format checks,completeness checks, check key tests,
|-
| CDISCglossary||protocol||data validation. 1. Checking data for correctness and/or compliance with applicable standards, rules, and
|-
| CDISCglossary||data||data. Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA]
|-
| CDISCglossary||protocol||database lock. Action taken to
|-
| CDISCglossary||data||database. A collection of data or
|-
| CDISCglossary||data||dataset. An organized collection of data or information with a common theme arranged in rows and columns
|-
| CDISCglossary||other||decision rule. Succinct statement of
|-
| CDISCglossary||document||Declaration of Helsinki. A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research
|-
| CDISCglossary||data||demographic data. Characteristics
|-
| CDISCglossary||statistics||dependent variable. Outcomes
|-
| CDISCglossary||statistics||derived variable. New variable
|-
| CDISCglossary||study design||design configuration. Clinical trial design developed to compare treatment groups in a clinical trial.Examples include: Parallel GroupDesign, Crossover Design, Factorial
|-
| CDISCglossary||plan||development plan. An ordered program of clinical trials, each with specific objectives.also clinical development plan
|-
| CDISCglossary||protocol||development process. See drug development process.
|-
| CDISCglossary||permission||direct access. Permission to examine, analyze, verify, and reproduce any records and reports that are important
|-
| CDISCglossary||protocol||discontinuation. The act of concluding participation, prior to completion of all protocol-requiredsubject NOTE: Four categories of discontinuation are distinguished: a)dropout: Active discontinuation by a discontinued subject); b) investigatorinitiated discontinuation (e.g., fo rcause); c) loss to follow-up: cessation cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation.
|-
| CDISCglossary||other||discrepancy. The failure of a datapoint to pass a validation check. NOTE:
|-
| CDISCglossary||other||disease. Any deviation from or interruption of the normal structure or function of a part, organ, or system of the body as manifested by characteristic symptoms and signs.
|-
| CDISCglossary||statistics||distribution. 1. In statistics, a group
|-
| CDISCglossary||pharmacokinetics||pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other
|-
| CDISCglossary||document||document (HL7). An ordered presentation of XML elements, possibly including text and tabular analyses,can be either physical (referring to the paper) or logical (referring to thecontent) with the followingcharacteristics: 1) Stewardship; 2)Potential for authentication; 3)Wholeness; 4) Human readability; 5)Persistence; 6) Global vs. local context.
|-
| CDISCglossary||computer||document root. The element in an XML document that contains all othe relements; the first element in the document.
|-
| CDISCglossary||format||document type definition (DTD).
|-
| CDISCglossary||document||documentation. All records, in any form (including, but not limited to,written, electronic, magnetic, andoptical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a
|-
| CDISCglossary||computer||domain name. The way a particular
|-
| CDISCglossary||quality||dosage form. Physical characteristicsof a drug product, (e.g., tablet,capsule, or solution) that contains adrug substance, generally
|-
| CDISCglossary||protocol||dosage regimen. The number ofdoses per given time period; theelapsed time between doses (for
|-
| CDISCglossary||quality||dosage strength. 1. Proportion of active substance to excipient, measured in units of volume or concentration. 2.The strength of a drug product. tells how much of the active ingredient is present in each dosage.
|-
| CDISCglossary||protocol||dosage. The amount of drugadministered to a patient or testsubject over the course of the clinicalstudy; a regulated administration ofindividual doses. [AMA Manual of
|-
| CDISCglossary||protocol||dose. The amount of drugadministered to a patient or testsubject at one time or the totalquantity administered. [AMA Manualof Style]
|-
| CDISCglossary||study||double-blind study. A study in
|-
| CDISCglossary||protocol||double-dummy. A technique forretaining the blind when administeringsupplies in a clinical trial, when the twotreatments cannot be made identical.
|-
| CDISCglossary||role||dropout. A subject in a clinical trialwho for any reason fails to continue inthe trial until the last visit orobservation required of him/her by the
|-
| CDISCglossary||protocol||drug development process. The
|-
| CDISCglossary||role||drug product. 1. A dosage form thatcontains an active drug ingredient orplacebo; 2. A finished dosage form asdescribed in regulations. [SPL Glossary]
|-
| CDISCglossary||computer||dynamic HTML. Collective term for a
|-
| CDISCglossary||ethics committee||EAB ethical advisory board
|-
| CDISCglossary||ethics committee||EC ethics committee
|-
| CDISCglossary||study||eClinical trial. Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access,exchange and archive data Syn eClinical study, eClinical investigation.
|-
| CDISCglossary||document||eCRF. 1. Auditable electronic record designed to capture information required by the clinical trial protocol to be reported to the sponsor on each trial subject. 2. A CRF in which related data items and their associated comments, notes, and signatures are linked electronically. NOTE: eCRFs may
|-
| CDISCglossary||document||eCRT. CRTs provided in electronic format for eSubmissions (electronic Submissions; FDA - SAS transport files; replaced by STDM
|-
| CDISCglossary||protocol||edit check. An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range or
|-
| CDISCglossary||data||effect. An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments.
|-
| CDISCglossary||quality||effectiveness. The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.
|-
| CDISCglossary||quality||efficacy. The capacity of a drug or treatment to produce beneficial effects
|-
| CDISCglossary||protocol||electronic data capture (EDC).
|-
| CDISCglossary||computer||electronic record. Any combination
|-
| CDISCglossary||computer||electronic signature. A computer
|-
| CDISCglossary||time||element. 1. In trial design, a basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.
|-
| CDISCglossary||computer||element2. A section of text in an XML
|-
| CDISCglossary||document||eMedical record. An electronic
|-
| CDISCglossary||data||endpoint. Variable that pertains to the efficacy or safety evaluations of a
|-
| CDISCglossary||protocol||enroll. To register or enter into a
|-
| CDISCglossary||aggregate population||enrollment (cumulative). Current enrollment as well as any ever-enrolled subjects who have ended participation.
|-
| CDISCglossary||aggregate||enrollment (current). Subjects actively continuing to participate in a
|-
| CDISCglossary||aggregate||enrollment (target). The number of subjects in a class or group intended to be enrolled in a trial.
|-
| CDISCglossary||aggregate||enrollment 2. The class of enrolled subjects in a clinical trial.
|-
| CDISCglossary||protocol||enrollment. 1. The act of enrolling
|-
| CDISCglossary||organization||Enterprise Vocabulary Services
|-
| CDISCglossary||time||epoch. An interval of time in the planned conduct of a study during which the treatment is consistent. Synonyms: period, cycle, phase, stage.
|-
| CDISCglossary||data||ePRO. PRO data initially captured electronically
|-
| CDISCglossary||quality||equipoise. A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.
|-
| CDISCglossary||study||equivalence trial. A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically primary objective of showing that the response to two or more treatments differs by an amount that is clinically
|-
| CDISCglossary||data||eSource data (electronic source data). Source data captured initially into a permanent electronic record used for the reconstruction and
|-
| CDISCglossary||document||eSource document (electronic
|-
| CDISCglossary||characteristic||established name. The official name of a drug substance.
|-
| CDISCglossary||organization||ethics committee. See institutional review board, independent ethics committee.
|-
| CDISCglossary||organization role||Ethics Committees
|-
| CDISCglossary||organization||European Medicines Agency (EMEA). The regulatory agency for EU
|-
| CDISCglossary||characteristic||evaluable (for efficacy and safety). Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in Efficacy/Safety
|-
| CDISCglossary||protocol||exclusion criteria. List of
|-
| CDISCglossary||pharmacokinetics||excretion. The act or process of eliminating waste products from the body
|-
| CDISCglossary||study||exploratory trial. Phase 1 or 2 trial during which the actions of a therapeutic intervention are assessed and measured. NOTE: Procedures in
|-
| CDISCglossary||computer||Extraction Transformation Load(ETL). A class of software applications for data extraction, transformation and loading that are used to implement
|-
| CDISCglossary||computer||File Transfer Protocol (FTP). A
|-
| CDISCglossary||doc||final report. A written description of
|-
| CDISCglossary||conclusion||finding. A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.
|-
| CDISCglossary||role||first subject in (FSI, FPI). The date and time the first subject is enrolled and randomized into a study. The
|-
| CDISCglossary||role||first subject screened. First subject who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial. who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
|-
| CDISCglossary||role||first subject treated. First subject who receives the test article or placebo in a clinical trial.
|-
| CDISCglossary||study||first-in-humans study. The first Phase 1 study in which the test product is administered to human beings. first-in-man study. See first-in humans study.
|-
| CDISCglossary||organization||Food and Drug Administration
|-
| CDISCglossary||document||Form. A collection of items and item groups for capturing and displaying clinical trial data.
|-
| CDISCglossary||statistics||frequentist methods. Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation.
|-
| CDISCglossary||protocol||frozen. Status of a database, file, or element that has been presumed to be in its final state pending “lock” and where further editing is prevented without “unfreezing.” NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from “locking”
|-
| CDISCglossary||role||functional roles (in a study). See role
|-
| CDISCglossary||characteristic||gender. Subject self-identification re: male/female
|-
| CDISCglossary||statistics||generalizability. The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. [ICH
|-
| CDISCglossary||characteristic||generic name. The drug identifying name to which all branded (proprietary) names for that indication are associated
|-
| CDISCglossary||conclusion||global assessment variable. A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator’s overall impression about the state or change in state of a subject.
|-
| CDISCglossary||document||glossary. A collection of specialized words or terms with their meanings.
|-
| CDISCglossary||standard||good clinical practice (GCP). A standard for the design, conduct,
|-
| CDISCglossary||standard||good clinical research practice(GCRP). Term sometimes used to describe GCP. See good clinical practice.
|-
| CDISCglossary||data||granularity. Refers to the size of an information unit in relation to a whole NOTE: Structuring “privileges” in electronic systems is said to be highly granular when each of many roles can differ in their capacity to act on electronic records.
|-
| CDISCglossary||study||group sequential design. A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests. [Center for
|-
| CDISCglossary||standard||harmonized standard. A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC).health authority. Synonym for regulatory authority. NOTE: used in the
|-
| CDISCglossary||organization||Health Level 7 (HL7). An ANSI accredited Standards Developing Organization (SDO) operating in the healthcare arena. NOTE: Level 7 refers to the highest level of the International Standards Organization’s (ISO)communications model for Open
|-
| CDISCglossary||role||healthcare provider. 1. One who directly or indirectly administers interventions that are designed to improve the physical or emotional status of patients. 2. A person licensed, certified or otherwise authorized or permitted by law to administer health
|-
| CDISCglossary||role||healthy volunteer. Subject (not a patient) in a clinical trial. NOTE: Usually healthy volunteers serve as subjects in Phase 1 trials.
|-
| CDISCglossary||ethics committee||HEX human experimentation committee
|-
| CDISCglossary||ethics committee||HSRC human subjects review committee
|-
| CDISCglossary||role||human subject. Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR50.3]. Synonym: subject/trial subject.
|-
| CDISCglossary||standard||Huriet Law. France’s regulations
|-
| CDISCglossary||computer||HyperText Markup Language
|-
| CDISCglossary||computer||hypertext. Links in a document that
|-
| CDISCglossary||hypothesis||hypothesis to test. In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value.
|-
| CDISCglossary||ethics committee||IEC independent ethics committee
|-
| CDISCglossary||role||impartial witness. A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who
|-
| CDISCglossary||protocol||inclusion criteria. The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. independent data monitoring
|-
| CDISCglossary||organization||independent data monitoring committee (IDMC). A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify,
|-
| CDISCglossary||organization||independent ethics committee(IEC). An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to
|-
| CDISCglossary||data||indication. A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. NOTE: Where such a benefit has been established and approved by regulatory authorities, the therapy is said to be approved for such
|-
| CDISCglossary||protocol||informed consent. An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. Informed consent is an ongoing, interactive process, rather than a onetime
|-
| CDISCglossary||organization||institution (medical). Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH]institutional review board (IRB). An independent body constituted of medical, scientific, and non-scientific
|-
| CDISCglossary||organization||institutional review board (IRB). An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among
|-
| CDISCglossary||protocol||instrument. A means to capture data (e.g., questionnaire, diary) plus all the information anddocumentation that supports its use.
|-
| CDISCglossary||standard||intention-to-treat. The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given.
|-
| CDISCglossary||statistics||interaction (qualitative and quantitative). The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (for example, the centre). A quantitative interaction
|-
| CDISCglossary||protocol||Interim analysis(es). Analysis comparing intervention groups at anytime before the formal completion of the trial, usually before recruitment is complete. [CONSORT Statement]interim analysis schedule. The time/information points at which
|-
| CDISCglossary||document||interim clinical trial/study report. A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH]internal consistency. Pertaining to data that do not include contradictions.
|-
| CDISCglossary||data quality||internal consistency. Pertaining to data that do not include contradictions.
|-
| CDISCglossary||computer||Internet service provider (ISP). A
|-
| CDISCglossary||computer||Internet. A global system of
|-
| CDISCglossary||computer||interoperability. Ability of two or more systems or components to exchange information and to use the information that has been exchanged.
|-
| CDISCglossary||other||interpretation of results. [from PRODraft Guidance] Compare to questionnaire, survey (see Comments on Draft PRO Guidance, April 4, 2006by ISOQoL, p. 8).intention-to-treat. The principle that asserts that the effect of a
|-
| CDISCglossary||quality||inter-rater reliability. The property of scales yielding equivalent results when used by different raters on different occasions.
|-
| CDISCglossary||role||intervention. The drug, device, therapy or process under investigation in a clinical trial which has an effect on outcome of interest in a study: e.g., health-related quality of life, efficacy, safety, pharmacoeconomics. Synonyms: therapeutic intervention, medical product. See also: test articles; devices;
|-
| CDISCglossary||role||investigational product. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
|-
| CDISCglossary||role||investigational treatment. An intervention under investigation in a clinical trial.
|-
| CDISCglossary||role||investigator. 1. A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. 2. The individual principal investigator. 2. The individual under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is See also sponsor-investigator.
|-
| CDISCglossary||||investigator/institution. An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
|-
| CDISCglossary||doc||investigator’s brochure. A compilation of the clinical and nonclinical data on the investigationalproduct(s) which is relevant to the study of the investigational product(s)in human subjects. item. 1. A representation of a clinical
|-
| CDISCglossary||ethics committee||IRB independent review board; institutional review board
|-
| CDISCglossary||data||item definition. 1. In a questionnaire or form to be completed in a clinical trial, the specification of a question and the specification of the format and semantics of the response.2. Formal specification of the properties of an item or field of data in an eClinical trial.
|-
| CDISCglossary||protocol||item generation. Establishing the content to be covered by the items in aPRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and
|-
| CDISCglossary||aggregate||item group definition. The specification in an eClinical Trial of a collection of items often clinically related to each other and useful to consider as an ensemble. NOTE: Item groups are likely to have greater granularity in analysis datasets using
|-
| CDISCglossary||data||item. 1. A representation of a clinical variable, fact, concept or instruction in a manner suitable for communication, interpretation or processing by humans or by automated means. NOTE: Items are collected together to form item groups. 2. An individual question, statement, or task that is evaluated by the patient to address a particular concept to be measured by a PRO instrument. [1. CDISC. 2. from PRO item definition. 1. In a questionnaire or form to be completed
|-
| CDISCglossary||other||Janus. 1. A logical design conceived by Dr. Norman Stockbridge of the FDA for a data warehouse intended to integrate submission data, protocol descriptions and analysis plans from clinical and animal studies into as an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining and retrospective comparative analysis. 2) the name assigned to a component of the NCI’s CaBIG Clinical Research Information Exchange (CRIX)
|-
| CDISCglossary||document||label. Description of a drug product/device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities[FDA; SPL] Synonyms: package insert,
|-
| CDISCglossary||organization||laboratory (clinical). A laboratory providing analyses of samples collected in clinical care or research.
|-
| CDISCglossary||time||last subject out/complete(LSC/LPC or LSO/LPO). 1. The date and time when the last subject has reached a planned or achieved milestone representing the completion of the trial. 2. The last subject to complete a trial. See also subject, pt, completion
|-
| CDISCglossary||||
|-
| CDISCglossary||time||legal authentication. A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document.
|-
| CDISCglossary||role||legally acceptable representative. An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject\'s participation in the clinical trial. [ICH, E6 Glossary]
|-
| CDISCglossary||role||Leiter der klinischen Prüfung.Under the German Drug Law, the physician who is head of the clinical investigation
|-
| CDISCglossary||unscheduled||life-threatening adverse event/experience. Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred event/experience. Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death. [FDA 21 CFR §312.32;ICH-E2A]
|-
| CDISCglossary||study||longitudinal study. Investigation in which data are collected from a number of subjects over a long period of time
|-
| CDISCglossary||ethics committee||LREC local research ethics committees (UK)
|-
| CDISCglossary||study||marketing support trials. Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decisionmakers the rationale for preferring one therapy over another.
|-
| CDISCglossary||computer||markup. Computer-processable annotations within a multimedia document. NOTE: In the context of the HL7specification, markup syntax is according to the XML Specification.
|-
| CDISCglossary||study||masking. See blinding.
|-
| CDISCglossary||study||matched-pair design. A type of parallel trial design in which investigators identify pairs of subjects who are “identical” with respect to relevant factors, then randomize them so that one receives Treatment A and the other Treatment B. See also pairing.
|-
| CDISCglossary||study||matching. See pairing.
|-
| CDISCglossary||statistics||mean. The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.
|-
| CDISCglossary||statistics||median. The middle value in a dataset; that is, just as many values are greater than the median and lower than the median value.
|-
| CDISCglossary||role||medical monitor. A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.medical product. See intervention.
|-
| CDISCglossary||role||medicinal product. Synonym for therapeutic intervention, but usually a drug.
|-
| CDISCglossary||organization||Medicines and Healthcareproducts Regulatory Agency(MHRA). The UK government agencyresponsible for ensuring thatmedicines and medical devices work,and are acceptably safe.
|-
| CDISCglossary||study||mega-trials. Massive clinical trialsthat test the advantages oftherapeutic interventions by enrolling10,000 or more subjects. Synonym:large sample trials.
|-
| CDISCglossary||document||Memorandum ofUnderstanding (MOU). A MOUbetween FDA and another regulatoryagency allows mutual recognition ofinspections.
|-
| CDISCglossary||data||message (HL7). The atomic unit ofdata transferred between systems. Itcomprises a group of segments in adefined sequence. Each message has amessage type that defines its purpose. For example, the Admission,Discharge and Transfer (ADT) Message
|-
| CDISCglossary||protocol||meta-analysis. The formalevaluation of the quantitativeevidence from two or more trialsbearing on the same question. NOTE:This most commonly involves thestatistical combination of summarystatistics from the various trials, but
|-
| CDISCglossary||pharmacokinetics||metabolism. The biochemicalalteration of substances introducedinto the body
|-
| CDISCglossary||data||metadata. Data that describe otherdata, particularly XML tagscharacterizing attributes of values inclinical data fields.
|-
| CDISCglossary||computer||migration. The act of moving a system or software product (including data) from an old to new operational environment in accordance with a software quality system
|-
| CDISCglossary||data role||missing data. 1. Data notcompleted, or corrupted in reports andcase report forms. 2. Particularly thedata not captured when a subjectwithdraws from a trial.
|-
| CDISCglossary||statistics||mode. The most frequently occurringvalue in a data set.model. A formal structure forrepresenting and analyzing a processsuch as a clinical trial or theinformation pertaining to a restrictedcontext, e.g., clinical trial data. [CDISC]
|-
| CDISCglossary||data model||model. A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context, e.g., clinical trial data.
|-
| CDISCglossary||computer||modem. From modulator/demodulator; a device that converts digital data into analog data that can be transmitted via telephone or cable lines used for communications. monitor. Person employed by the sponsor or CRO who is responsible for
|-
| CDISCglossary||role||monitor. Person employed by thesponsor or CRO who is responsible fordetermining that a trial is beingconducted in accordance with theprotocol and GCP guidance. NOTE: Amonitor’s duties may include, but arenot limited to, helping to plan and
|-
| CDISCglossary||organization||monitoring committee. Seeindependent data-monitoringcommittee.
|-
| CDISCglossary||document||monitoring report. A written reportfrom the monitor to the sponsor aftereach site visit and/or other trial-relatedcommunication according to thesponsor’s SOPs.
|-
| CDISCglossary||protocol||monitoring visit. A visit to a studysite to review the progress of a clinicalstudy and to ensure protocoladherence, accuracy of data, safety ofsubjects, and compliance withregulatory requirements and goodclinical practice guidelines. [from ICH
|-
| CDISCglossary||protocol||monitoring. The act of overseeingthe progress of a clinical trial, and ofensuring that it is conducted, recorded,and reported in accordance with theprotocol, standard operating procedures(SOPs), good clinical practice(GCP), and the applicable regulatory
|-
| CDISCglossary||ethics committee||MREC multicentre research ethics committees (UK)
|-
| CDISCglossary||study||multicenter study. See multicenter trial.
|-
| CDISCglossary||study||multicenter trial. Clinical trialconducted according to a singleprotocol but at more than one site,and, therefore, carried out by morethan one investigator. [ICH E9 Glossary]Synonym: multicenter study; seeinvestigator/institution.
|-
| CDISCglossary||computer||natural language. Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines.
|-
| CDISCglossary||document||New Drug Application (NDA). Anapplication to FDA for a license tomarket a new drug in the UnitedStates.n-of-1 study. A trial in which anindividual subject is administered atreatment repeatedly over a number of
|-
| CDISCglossary||ethics committee||NIRB noninstitutional review board
|-
| CDISCglossary||study||n-of-1 study. A trial in which anindividual subject is administered atreatment repeatedly over a number ofepisodes to establish the treatment’seffect in that person, often with theorder of experimental and controltreatments randomized.
|-
| CDISCglossary||study||nonclinical study. Biomedicalstudies not performed on humansubjects.
|-
| CDISCglossary||document||not approvable letter. An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.
|-
| CDISCglossary||organization||Notified Body (NB). A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB.
|-
| CDISCglossary||ethics committee||NRB noninstitutional review board, also known as an independent review board
|-
| CDISCglossary||statistics||null hypothesis. The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. NOTE: A null hypothesis (for
|-
| CDISCglossary||document||Nuremberg Code. Code of ethics, set forth in 1947, for conducting human medical research. objective. The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing).
|-
| CDISCglossary||data||objective measurement. A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment. See also outcome, patient-reported outcome;
|-
| CDISCglossary||data||observation. 1. An assessment of patient condition or analysis of data collected on an individual patient or group of patients. 2. (SDTM) A discrete piece of information collected during a study.
|-
| CDISCglossary||data||observer assessment. An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.). NOTE: Distinguished from self-assessment. The observer relies on his or her judgment to assess the subject. An
|-
| CDISCglossary||trigger||open to enrollment. The status of a study such that a subject can be enrolled into that study.
|-
| CDISCglossary||study design||open-label study. A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding. open to enrollment. The status of a study such that a subject can be
|-
| CDISCglossary||standard||operational model. The set of CDISC data standards (including ODMand LAB) used to capture and archive data from clinical trials.
|-
| CDISCglossary||document||opinion (in relation to independent ethics committee). The judgment and/or the advice provided by an independent ethics committee.
|-
| CDISCglossary||metadata||origin. 1) Source of information collected in the course of a clinical trial. Specifically used to differentiate between data collected at point of patient contact and data that are derived or calculated. 2) (SDTM) A metadata attribute defined for each dataset variable in the “Define\" document of an SDTM submission that refers to the source of a variable (e.g.,CRF, derived, sponsor defined, PRO,etc.).
|-
| CDISCglossary||evidence code||original data. Those values that represent the first recording of study data. [CSUCT Definitions]outcome (of adverse event). Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology
|-
| CDISCglossary||data||outcome (of adverse event). Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved, recovering/ resolving, not recovered/not resolved, recovered /resolved with sequelae, fatal, or unknown
|-
| CDISCglossary||data||outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective
|-
| CDISCglossary||other||outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective
|-
| CDISCglossary||science||outcomes research. Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions.
|-
| CDISCglossary||statistics||outliers. Values outside of an expected range. packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to
|-
| CDISCglossary||mixed||packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.
|-
| CDISCglossary||protocol||pairing. A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B. See also matched-pair design.
|-
| CDISCglossary||study||parallel trial. Subjects are randomized to one of two or more differing treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. Synonyms: parallel group trial, parallel design trial
|-
| CDISCglossary||statistics||parameter. A variable in a model, or a variable that wholly or partially characterizes a probability distribution mathematics and statistics). NOTE: In clinical trials the term is often used synonymously with “variable” for factual information (age, date of
|-
| CDISCglossary||role||participant. A person or entity with a role in healthcare or a clinical study.NOTE: Participants in a clinical trial may include subjects and study personnel. A subject participates as part of the group of people who are administered the therapeutic intervention or control.
|-
| CDISCglossary||document||patient file. One that contains demographic, medical, and treatment information about a patient or subject. It may be paper- or computer-based or a mixture of computer and paperrecords.
|-
| CDISCglossary||document||patient package leaflet. labeling (content of). All text, tables and figures in labeling as described in regulations for a specific product
|-
| CDISCglossary||role||patient. Person under a physician\'s care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. See also subject, trial subject, healthy volunteer. Often used interchangeably
|-
| CDISCglossary||evidence code||patient-reported outcome (PRO).Report coming directly from patients or subjects through interviews or selfcompleted questionnaires or other data capture tools such as diaries about their life, health condition(s) and treatment. NOTE: subjective measurement
|-
| CDISCglossary||data||patient-reported outcome; objective measures are observations (SDTM) and could be endpoints. Patient-reported outcomes are subjective measurements.
|-
| CDISCglossary||data||permanent data. Data that become or are intended to become part of an electronic record in relation to a regulatory submission. Any changes made to such permanent data are recorded via an audit trail so that prior values are not obscured.
|-
| CDISCglossary||role||per-protocol analysis set. The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.
|-
| CDISCglossary||pharmacokinetics||pharmacodynamics. Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents.pharmacoeconomics. Branch of
|-
| CDISCglossary||pharmacokinetics||pharmacoeconomics. Branch of economics that applies cost-benefit, cost-utility, cost-minimization, and cost-effectiveness analyses to assess the utility of different pharmaceutical products or to compare drug therapy to other treatments.
|-
| CDISCglossary||protocol||pharmacogenetic test. An assay intended to study inter individual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.
|-
| CDISCglossary||pharmacokinetics||pharmacogenetics. Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.pharmacogenomic test. An assay intended to study interindividual variations in whole genome or
|-
| CDISCglossary||protocol||pharmacogenomic test. An assay intended to study interindividual variations in whole genome or candidate gene maps, biomarkers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response. Compare to pharmacogenetic test.pharmacogenomics. Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to
|-
| CDISCglossary||pharmacokinetics||pharmacogenomics. Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to predict whether a person will respond favorably, adversely, or not at all to an investigational product.
|-
| CDISCglossary||pharmacokinetics||pharmacokinetics. Study of the processes of bodily absorption, distribution, metabolism, and excretion(ADME) of medicinal products. pharmacology. Science that deals with the characteristics, effects, and uses of drugs and their interactions
|-
| CDISCglossary||pharmacokinetics||pharmacology. Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.pharmacovigilance. Term used for adverse event monitoring and reporting.
|-
| CDISCglossary||phase||pharmacovigilance. Term used for adverse event monitoring and reporting.phase. Clinical trials are generally categorized into four (sometimes five) phases described below. A therapeutic intervention may be evaluated in two
|-
| CDISCglossary||study||Phase 1. The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted inpatients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
|-
| CDISCglossary||study||Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug
|-
| CDISCglossary||study||Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit–risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3studies usually include from several
|-
| CDISCglossary||study||Phase 3b. A subcategory of Phase 3trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval.
|-
| CDISCglossary||study||Phase 4. Postmarketing (Phase 4)studies to delineate additional information about the drug’s risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but
|-
| CDISCglossary||study||Phase 5. Postmarketing surveillance is sometimes referred to as Phase 5. See also outcomes research. placebo. A pharmaceutical preparation that does not contain the investigational agent. In blinded studies, it is generally prepared to be
|-
| CDISCglossary||study design||phase. Clinical trials are generally categorized into four (sometimes five) phases A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
|-
| CDISCglossary||role||placebo. A pharmaceutical preparation that does not contain the investigational agent. In blinded studies, it is generally prepared to be physically indistinguishable from the preparation containing the investigational product.
|-
| CDISCglossary||aggregate||population. Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled.
|-
| CDISCglossary||protocol||post marketing surveillance. Ongoing safety monitoring of marketed drugs. See also Phase 4studies, Phase 5 studies. pragmatic trial. Term used to describe a clinical study designed to examine the benefits of a product
|-
| CDISCglossary||study||pragmatic trial. Term used to describe a clinical study designed to examine the benefits of a product under real world conditions. preclinical studies. Animal studies that support Phase 1 safety and tolerance studies and must comply
|-
| CDISCglossary||study||preclinical studies. Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP).NOTE: Data about a drug’s activities and effects in animals help establish boundaries for safe use of the drug in
|-
| CDISCglossary||document||Pre-Market Approval Application (PMA). An application to FDA for a license to market a new device in the United States. primary objective. The primaryobjective(s) is the main question to be answered and drives any statistical
|-
| CDISCglossary||role||primary variable. An outcome of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions.
|-
| CDISCglossary||role||product. 1. Drug product: A finished dosage form that contains a drug substance. 2. A physical entity that is intended to diagnose, treat, or prevent a disease or other abnormal condition, and subject to regulatory authority
|-
| CDISCglossary||organization||PROMIS. NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function and emotional well-being. [NIH]proprietary name. A commercial
|-
| CDISCglossary||characteristic||proprietary name. A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL] Synonyms: trade name, brand name. prospective study. Investigation in which a group of subjects is recruited
|-
| CDISCglossary||study||prospective study. Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol. protocol. A document that describes the objective(s), design, methodology, statistical considerations, and
|-
| CDISCglossary||document||protocol amendment(s). A written description of a change(s) to or formal clarification of a protocol. [ICH E3]protocol approval (Sponsor). Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer
|-
| CDISCglossary||protocol||protocol approval (Sponsor). Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated
|-
| CDISCglossary||unscheduled||protocol deviation. A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor
|-
| CDISCglossary||characteristic||Protocol Identifying Number. Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers
|-
| CDISCglossary||document||protocol referenced documents. Protocol referenced documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [from ICH E61.44] See also protocol.
|-
| CDISCglossary||characteristic||protocol violation. A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per protocol analysis, and may require that the subject (s) who violate the protocol
|-
| CDISCglossary||unscheduled||protocol violation. A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per protocol analysis, and may require that the subject(s) who violate the protocol
|-
| CDISCglossary||document||protocol. A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocoldocuments.NOTE: Present usage can refer to any of three distinct entities: 1)the plan (i.e., content) of a protocol, 2)the protocol document and 3) a series of tests or treatments (as in oncology).
|-
| CDISCglossary||protocol||protocolauthority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that maybe located at the site of the trial, at the
|-
| CDISCglossary||data||proxy (as an origin of outcome measures). A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures. Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO)directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. [CDISC (extension
|-
| CDISCglossary||person role||proxy respondent. Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. Compare to observer assessment.
|-
| CDISCglossary||other||psychometric reliability. See reliability, psychometric.
|-
| CDISCglossary||protocol||psychometric validation. The specialized process of validating questionnaires used in outcomes research to show that they measure what they purport to measure. NOTE: Several types of validity are distinguished. For example, face validity means that an assessment instrument appears by inspection and consideration of the semantic content of items in it to be measuring what it is supposed to measure. Construct validity means that a scale based on one or more items measures an unobservable psychological construct(e.g., “distress”) that it is proposed to measure. Construct validity is usually tested by measuring the correlation in assessments obtained from several scales purported to measure the same construct. [Guyatt et al., 1993; DIA
|-
| CDISCglossary||science||psychometrics. The science of assessing the measurement characteristics of scales that assess human psychological characteristics.
|-
| CDISCglossary||statistics||p-value. Study findings can also be
|-
| CDISCglossary||statistics||qualitative variable. One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes.
|-
| CDISCglossary||protocol||quality assurance (QA). All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable
|-
| CDISCglossary||protocol||quality control (QC). The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.[ICH]
|-
| CDISCglossary||quality||quality of life. A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationships to salient features of the environment.
|-
| CDISCglossary||statistics||quantitative variable. One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum. query. A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or
|-
| CDISCglossary||protocol||query management. Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data. query resolution. The closure of a query usually based on information
|-
| CDISCglossary||protocol||query resolution. The closure of a query usually based on information contained in a data clarification. questionnaire. A set of questions or items shown to a respondent in order to get answers for research purposes.[PRO Draft Guidance] See also
|-
| CDISCglossary||document||query. A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.
|-
| CDISCglossary||document assay||questionnaire. A set of questions or items shown to a respondent in order to get answers for research purposes.[PRO Draft Guidance] See also instrument, survey.
|-
| CDISCglossary||protocol||random allocation. Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: In a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.
|-
| CDISCglossary||statistics||random number table. Table of numbers with no apparent pattern used in the selection of random samples for clinical trials. random sample.
|-
| CDISCglossary||role||random sample. Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection. randomization. The process of assigning trial subjects to treatment or
|-
| CDISCglossary||protocol||randomization. The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects maybe assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balancedstudy.raw data. Data as originally collected.
|-
| CDISCglossary||data||raw data. Data as originally collected. Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments)
|-
| CDISCglossary||organization||RCRIM. Regulated Clinical Research and Information Management, which is a Technical Committee within HL7 (an acronym pronounced “arcrim”).
|-
| CDISCglossary||ethics committee||REB research ethics board (Canada)
|-
| CDISCglossary||ethics committee||Recherches Biomédicales (France)
|-
| CDISCglossary||protocol||reconstruction (of a study). For eClinical trials FDA expects archival trial records to support review of the data
|-
| CDISCglossary||protocol||recruitment (investigators).Process used by sponsors to identify,select and arrange for investigators toserve in a clinical study.
|-
| CDISCglossary||protocol||recruitment (subjects). Processused by investigators to find and enrollappropriate subjects (those selected onthe basis of the protocol’s inclusion andexclusion criteria) into a clinical study.
|-
| CDISCglossary||time||recruitment period. Time period during which subjects are or are planned to be enrolled in a clinical trial.
|-
| CDISCglossary||protocol||recruitment target. Number ofsubjects that must be recruited ascandidates for enrollment into a studyto meet the requirements of theprotocol. In multicenter studies, eachinvestigator has a recruitment target.Reference Information Model
|-
| CDISCglossary||data model||Reference Information Model(RIM). An information model used as the ultimate defining reference for al lHL7 standards.
|-
| CDISCglossary||data||registry. A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
|-
| CDISCglossary||organization or role||regulatory authorities. Bodieshaving the power to regulate. NOTE: Inthe ICH GCP guideline the termincludes the authorities that reviewsubmitted clinical data and those thatconduct inspections. These bodies aresometimes referred to as competent
|-
| CDISCglossary||quality||reliability, psychometric. The degree to which a psychometric “instrument” is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time
|-
| CDISCglossary||other||reliability, psychometric. Thedegree to which a psychometric“instrument” is free from random erroreither by testing the homogeneity ofcontent on multi-item tests withinternal consistency evaluation ortesting the degree to which theinstrument yields stable scores over time
|-
| CDISCglossary||protocol||replacement. The act of enrolling aclinical trial subject to compensate forthe withdrawal of another.representative. See legallyacceptable representative.research hypothesis. Theproposition that a study sets out to
|-
| CDISCglossary||role||representative. See legallyacceptable representative.
|-
| CDISCglossary||hypothesis||research hypothesis. The proposition that a study sets out to support (or disprove); for example,“blood pressure will be lowered by[specific endpoint] in subjects who receive the test product.” See also null hypothesis.
|-
| CDISCglossary||data||Researcher’s records of subjects/patients, such as patient medical charts, hospital records, X-rays,and attending physician’s notes. NOTE:These records may or may not accompany an application to a Regulatory Authority, but must be kept
|-
| CDISCglossary||document||result synopsis. The brief reportprepared by biostatisticianssummarizing primary (and secondary)efficacy results and key demographicinformation.
|-
| CDISCglossary||study||retrospective. Capture of clinicaltrial data is retrospective when it isrecalled from memory rather thancaptured contemporaneously in realtime.NOTE: Retrospective capture isimportant in PROs because of “recallbias” and other errors documented in
|-
| CDISCglossary||quality||risk. In clinical trials, the probability of harm or discomfort for subjects. NOTE:Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat,for example, will be expected to have a low incidence of troubling side effects.
|-
| CDISCglossary||role||role. 1. The function or responsibilityassumed by a person in the context ofa clinical study. Examples include datamanager, investigator. 2. Classifier forvariables that describe “observations”in the SDTM. Role is a metadataattribute that determines the type ofinformation conveyed by anobservation-describing variable andstandardizes rules for using thedescribing variable. [1. HL7. 2. SDTM]See also functional role.safety. Relative freedom from harm.
|-
| CDISCglossary||quality||safety and tolerability. The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs andsymptoms), and other special safetytests (e.g., ECGs, ophthalmology). The tolerability of the medical productrepresents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]
|-
| CDISCglossary||quality||safety. Relative freedom from harm.In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests andprocedures, psychiatric evaluation,
|-
| CDISCglossary||protocol||sample size adjustment. Aninterim check conducted on blindeddata to validate the sample sizecalculations or re-evaluate thesample size.screen failure. Potential subject whodid not meet one or more criteria
|-
| CDISCglossary||statistics||sample size. 1. A subset of a largerpopulation, selected for investigationto draw conclusions or make estimatesabout the larger population. 2. Thenumber of subjects in a clinical trial. 3.Number of subjects required forprimary analysis.
|-
| CDISCglossary||role||screen failure. Potential subject whodid not meet one or more criteriarequired for participation in a trial. Seealso screening of subjects.screen/screening (ofsubstances). Screening is the processby which substances are evaluated in a
|-
| CDISCglossary||protocol||screen/screening (ofsubstances). Screening is the processby which substances are evaluated in abattery of tests or assays (screens)designed to detect a specific biologicalproperty or activity. It can be conductedon a random basis in which substances
|-
| CDISCglossary||protocol||screening (of sites). Determiningthe suitability of an investigative siteand personnel to participate in aclinical trial.screening (of subjects). A processof active consideration of potentialsubjects for enrollment in a trial. See
|-
| CDISCglossary||protocol||screening (of subjects). A processof active consideration of potentialsubjects for enrollment in a trial. Seealso screen failure.
|-
| CDISCglossary||study||screening trials. Trials conducted todetect persons with early, mild andasymptomatic disease.script. A program or a sequence ofinstructions that are interpreted orcarried out by another program or bya person.
|-
| CDISCglossary||computer||script. A program or a sequence of instructions that are interpreted or carried out by another program or by a person. secondary objective. See objective. secondary variable. The primary outcome is the outcome of greatest
|-
| CDISCglossary||study||See also blinding/masking, double-blind study, single-blind study, triple-blind study; contrast with open-label or unblinded study.
|-
| CDISCglossary||unshceduled event||See also serious adverse event, serious adverse experience.
|-
| CDISCglossary||||semantic. In the context of a technical specification, semantic refers to the meaning of an element asdistinct from its syntax. Syntax canchange without affecting semantics.
|-
| CDISCglossary||unscheduled||serious adverse event (SAE) orserious adverse drug reaction(serious ADR). Any untowardmedical occurrence that at any dose:results in death, is life threatening,requires inpatient hospitalization orprolongation of existing hospitalization,
|-
| CDISCglossary||unscheduled||serious adverse experience. Anyexperience that suggests a significanthazard, contra-indication, side effect orprecaution. See also serious adverseevent.server. A computer that controls acentral repository of data, files and/or
|-
| CDISCglossary||computer||server. A computer that controls a central repository of data, files and/or applications that can be accessed and/or manipulated in some manner by client computers. A
|-
| CDISCglossary||characteristic||sex. Maleness or femaleness, as defined by chromosomal makeup. See also gender. side effects. Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea,
|-
| CDISCglossary||unscheduled||side effects. Any actions or effectsof a drug or treatment other than theintended effect. Negative or adverseeffects may include headache, nausea,hair loss, skin irritation, or otherphysical problems. Experimental drugsmust be evaluated for both immediate
|-
| CDISCglossary||study design||single-blind study. A study in which one party, either the investigatoror the subject, does not know which medication or placebo is administered to the subject; also called single masked study. See also blind study,double-blind study, triple-blind study.
|-
| CDISCglossary||protocol||software validation. Confirmationby examination and provision ofobjective evidence that softwarespecifications conform to user needsand intended uses, and that theparticular requirements implementedthrough software can be consistently
|-
| CDISCglossary||computer||software. Computer programs,procedures, rules, and any associated documentation pertaining to the operation of a system.software validation.
|-
| CDISCglossary||protocol||source data verification. Theprocess of ensuring that data that havebeen derived from source dataaccurately represent the source data.source document verification.The process by which the informationreported by an investigator is comparedwith the original records to ensure thatit is complete, accurate and valid.[Schuyl and Engel, 1999; Khosla et al.,Indian J. Pharm 32:180–186, 2000]Synonym: SDV. See also validation ofdata.
|-
| CDISCglossary||data||source data. All information in original records and certified copies of original records of clinical findings,observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
|-
| CDISCglossary||document||source documents. Originaldocuments, data, and records (e.g.,hospital records, clinical and officecharts, laboratory notes, memoranda,subjects’ diaries or evaluationchecklists, pharmacy dispensingrecords, recorded data from automated
|-
| CDISCglossary||population||special populations. Subsets ofstudy populations of particular interestincluded in clinical trials to ensure thattheir specific characteristics areconsidered in interpretation of data[e.g., geriatric].
|-
| CDISCglossary||human role||sponsor. 1. An individual, company,institution, or organization that takes responsibility for the initiation,management, and/or financing of aclinical trial. 2. A corporation or agencywhose employees conduct the investigation is considered a sponsor; employees are considered investigators
|-
| CDISCglossary||human role||sponsor-investigator. An individualwho both initiates and conducts, aloneor with others, a clinical trial, andunder whose immediate direction theinvestigational product is administeredto, dispensed to, or used by a subject.NOTE: The term does not include any person other than an individual, hence not a corporation, agency
|-
| CDISCglossary||statistics||standard deviation. Indicator of the relative variability of a variable around its mean; the square root of the variance.
|-
| CDISCglossary||standard||standard of care. A guideline for medical management and treatment.
|-
| CDISCglossary||plan||standard operating procedures(SOPs). Detailed, written instructions to achieve uniformity of the performance of a specific function
|-
| CDISCglossary||reference||standard treatment. A treatment currently in wide use and approved by the FDA or other health authority,considered to be effective in the treatment of a specific disease or condition.
|-
| CDISCglossary||plan||statistical analysis plan. Adocument that contains a moretechnical and detailed elaboration ofthe principal features of the analysisdescribed in the protocol, and includesdetailed procedures for executing thestatistical analysis of the primary and secondary variables and other data
|-
| CDISCglossary||protocol||statistical method. The particular mathematical tests and techniques that are to be used to evaluate the clinicaldata in a trial.
|-
| CDISCglossary||statistics||statistical significance. State tha tapplies when a hypothesis is rejected.Whether or not a given result is significant depends on the significance level adopted.
|-
| CDISCglossary||statistics||stochastic. Involving a randomvariable; involving chance orprobability.
|-
| CDISCglossary||protocol||stopping rules. A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great
|-
| CDISCglossary||standard||structured product label (SPL).The Structured Product Labeling (SPL)specification is an HL7 ANSI-approveddocument markup standard thatspecifies the structure and semanticsfor the exchange of productinformation. [HL7]
|-
| CDISCglossary||human role||study coordinator. See clinical research coordinator
|-
| CDISCglossary||study||study description. Representationof key elements of study; e.g., control,blinding, gender, dose, indication,configuration.
|-
| CDISCglossary||study||study design rationale. Reason for choosing the particular study design.
|-
| CDISCglossary||study||study design schematic.Diagrammatic representation of keyactivities within the study.
|-
| CDISCglossary||study||study design. Plan for the preciseprocedure to be followed in a clinicaltrial, including planned and actualtiming of events, choice of controlgroup, method of allocatingtreatments, blinding methods; assignsa subject to pass through one or more epochs in the course of the trial
|-
| CDISCglossary||date||study initiation. Date and time ofinformed consent of first subjectenrolled into a study. [ICH E3] Compareto study start. Synonym: date of firstenrollment.
|-
| CDISCglossary||population||study population. Defined byprotocol inclusion/exclusion criteria.study protocol. See protocol.
|-
| CDISCglossary||protocol||study protocol. See protocol.
|-
| CDISCglossary||event||study start. The formal recognition ofthe beginning of a clinical trial that isreferred to in the clinical study report.
|-
| CDISCglossary||role||study variable. A term used in trialdesign to denote a variable to becaptured on the CRF. See also variable.
|-
| CDISCglossary||study||study. See clinical trial. NOTE:Occasionally refers to a project of several related clinical trials.
|-
| CDISCglossary||human role||sub-investigator. Any member ofthe clinical trial team designated andsupervised by the investigator at a trialsite to perform critical trial-relatedprocedures and/or to make importanttrial-related decisions (e.g., associates,residents, research fellows) [ICH] See associates, residents, research fellows
|-
| CDISCglossary||event||subject data event. A subject visitor other encounter where subject dataare collected, generated or reviewed.
|-
| CDISCglossary||identifier||subject identification code. Aunique identifier assigned by theinvestigator to each trial subject toprotect the subject’s identity and usedin lieu of the subject’s name when theinvestigator reports adverse eventsand/or other trial-related data.
|-
| CDISCglossary||human role||subject/trial subject. An individualwho participates in a clinical trial,either as recipient of the investigationalproduct(s) or as a control. [ICH] Seealso healthy volunteer, human subject.
|-
| CDISCglossary||data||subject-reported outcome (SRO).
|-
| CDISCglossary||evidence code||subject-reported outcome (SRO).An outcome reported directly by asubject in a clinical trial. [Patrick, D.L.,2003] See also patient-reportedoutcome (PRO).
|-
| CDISCglossary||data format||submission model. A set of datastandards (including SDTM, ADaM anddefine.xml) for representing data thatare submitted to regulatory authoritiesto support product marketingapplications. NOTE: CDISC submissiondata consist of: tabulations thatrepresent the essential data collectedabout patients; analysis data structuredto support analysis and interpretation;and metadata descriptions.
|-
| CDISCglossary||study||superiority trial. A trial with theprimary objective of showing that theresponse to the investigational productis superior to a comparative agent(active or placebo control). [ICH E9]supplier. An organization that entersinto a contract with the acquirer for
|-
| CDISCglossary||organization role||supplier. An organization that entersinto a contract with the acquirer for the supply of a system, softwareproduct, or software service under theterms of a contract.
|-
| CDISCglossary||role||supporting variables. See variable
|-
| CDISCglossary||role||surrogate marker. A measurementof a drug’s biological activity thatsubstitutes for a clinical endpoint suchas death or pain relief.
|-
| CDISCglossary||role||surrogate variable. A variable thatprovides an indirect measurement ofeffect in situations where directmeasurement of clinical effect is notfeasible or practical.
|-
| CDISCglossary||protocol||survey. Any means (e.g.,questionnaire, diary, interview script,group of items) that is used to collectPRO data. NOTE: Survey refers to thecontent of the group of items and doesnot necessarily include the training andscoring documents generally not seen by respondants
|-
| CDISCglossary||other||syntactic. The order, format, contentof clinical trial data and/or documentsas distinct from their meaning NOTE:Syntactic interoperability is achievedwhen information is correctlyexchanged between two systemsaccording to structured rules whether or not sensible meaning is preserved
|-
| CDISCglossary||aggregate||system. People, machines, software, applications and/or methods organized to accomplish a set of specific functions or objectives.
|-
| CDISCglossary||protocol||target enrollment. The number ofsubjects in a class or group (includingthe total for the entire trial) intendedto be enrolled in a trial to reach theplanned sample size. Targetenrollments are set so that statisticaland scientific objectives of a trial will be met
|-
| CDISCglossary||role||technology provider. A person,company or other entity who develops,produces and sells softwareapplications and/or hardware for use inconducting clinical trials and/or inanalyzing clinical trial data and orsubmitting clinical trial information for regulatory approval
|-
| CDISCglossary||event||termination (of subject). Nowconsidered nonstandard. Seediscontinuation.
|-
| CDISCglossary||event||termination (of trial). Prematurediscontinutation of a trial prior to plan.
|-
| CDISCglossary||standard||terminology. A standardized, finiteset of terms (e.g., picklists, ICD9 codes)that denote patient findings,circumstances, events, andinterventions. NOTE: The terms shouldhave sufficient detail to support clinicalresearch, healthcare decisions,outcomes research and qualityimprovement. Standardization shouldbe sufficient that the same set of termsmay be extended to administrative,regulatory, and fiscal applications. [J.J.Cimino] Compare to glossary, which isa list of words and their definitionspertaining to usage in a particular fieldor context.
|-
| CDISCglossary||protocol||therapeutic intervention. Seeintervention
|-
| CDISCglossary||protocol||Time-of-entry editchecks are a type of edit check that isrun (executed) at the time data arefirst captured or transcribed to an
|-
| CDISCglossary||document||Tome. Record documenting everycomment on proposed regulations thathas been addressed by FDA
|-
| CDISCglossary||protocol||transcription. Process oftransforming dictated or otherwisedocumented information from onestorage medium to another. NOTE:often refers explicitly to data that ismanually transcribed from source docsor measuring devices to CRFs or to eCRFs
|-
| CDISCglossary||event||treatment effect. An effectattributed to a treatment in a clinicaltrial. In most clinical trials thetreatment effect of interest is acomparison (or contrast) of two ormore treatments.
|-
| CDISCglossary||event||treatment-emergent adverseevent. An event that emerges duringtreatment, having been absentpretreatment, or worsens relative tothe pretreatment state.
|-
| CDISCglossary||role||trial coordinator. See clinicalresearch coordinator.
|-
| CDISCglossary||standard||Trial Design Model. Defines astandard structure for representing theplanned sequence of events and thetreatment plan of a trial. NOTE: acomponent of the SDTM that buildsupon elements, arms epochs, visits;suitable also for syntactic interpretationupon elements, arms epochs, visits;suitable also for syntactic interpretationby machines. [CDISC] See study design.
|-
| CDISCglossary||role||trial site. The location(s) where trialrelatedactivities are actuallyconducted.
|-
| CDISCglossary||human role||trial statistician. A statistician whohas a combination ofeducation/training and experiencesufficient to implement the principles inthe ICH E9 guidance and who isresponsible for the statistical aspects ofthe trial. [ICH E9]
|-
| CDISCglossary||role||trial subject. Subject in a clinicaltrial. See also participant, patient,subject
|-
| CDISCglossary||study design||triple-blind study. A study in whichknowledge of the treatmentassignment(s) is concealed from thepeople who organize and analyze thedata of a study as well as from subjectsand investigators.
|-
| CDISCglossary||statistics||t-test. A statistical test used tocompare the means of two groups oftest data
|-
| CDISCglossary||statistics||type 1 (or type I) error. Error madewhen a null hypothesis is rejected butis actually true. Synonym: false positive.type 2 (or type II) error. Errormade when an alternative hypothesis isrejected when it is actually true.Synonym: false negative.
|-
| CDISCglossary||statistics||type 2 (or type II) error. Errormade when an alternative hypothesis isrejected when it is actually true.Synonym: false negative.
|-
| CDISCglossary||statistics||type 3 (or type III) error. Somestatisticians use this designation for anerror made when calling the lesseffective treatment the more effectiveone.
|-
| CDISCglossary||protocol||type of comparison. Howtreatment arms will be compared, e.g.,Safety, Efficacy, PK/PD. May alsoinclude comparison to data from otherstudies or sources; e.g., historicalcontrol.
|-
| CDISCglossary||protocol||unblinding. Identification of thetreatment code of a subject or groupedresults in studies where the treatmentassignment is unknown to the subjectand investigators
|-
| CDISCglossary||statistics||unequal randomization. Seerandomization.
|-
| CDISCglossary||unscheduled||unexpected adverse drugreaction. An adverse reaction, whosenature, severity, specificity, or outcomeis not consistent with the term ordescription used in the applicableproduct information. See alsoadverse drug reaction.
|-
| CDISCglossary||computer||uniform resource locator (URL).Address of a Web page,actmagazine.com, for example
|-
| CDISCglossary||protocol||user site testing (UST). Any testingthat takes place outside of thedeveloper’s controlled environment.NOTE: Terms such as beta test, sitevalidation, user acceptance test,installation verification, and installationtesting have all been used to describe UST
|-
| CDISCglossary||characteristic; evidence code||valid. 1. Sound. 2. Well grounded on principles of evidence. 3. Able to withstand criticism or objection
|-
| CDISCglossary||protocol||validation of data. 1. A processused to determine if data areinaccurate, incomplete, orunreasonable. The process may includeformat checks, completeness checks,check key tests, reasonableness checksand limit checks. 2. The checking ofdata for correctness or compliance withapplicable standards, rules, andconventions. NOTE: Meaning 1. is not“data verification” but meaning 2.could be
|-
| CDISCglossary||protocol||validation. 1. Process ofestablishing suitability to purpose. 2.For software and systems, establishingdocumented evidence which providesa high degree of assurance that aspecific process will consistentlyproduce a product meeting itspredetermined specifications andquality attributes. NOTE: Validation isaccomplished by planning how tomeasure and/or evaluate suitability topurpose; then executing the plan anddocumenting the results. [FDA
|-
| CDISCglossary||protocol||validity, psychometric. Seepsychometric validation.
|-
| CDISCglossary||protocol||validity. See validation.
|-
| CDISCglossary||role||variable. 1. Any quantity that varies;any attribute, phenomenon or eventthat can have different qualitative orquantitative values. 2. In SDTM“variables” are used to describeobservations. Such describingvariables have roles that determine the type of information conveyed by the variable about each observation and how it can be used
|-
| CDISCglossary||statistics||variance. A measure of the
|-
| CDISCglossary||computer||verification Provides objective evidence that the design outputs of a particular phaseof the software development life cycle meet all of the specified requirements
|-
| CDISCglossary||protocol||verification. 1. The act of reviewing, inspecting, testing,checking, auditing, or otherwise establishing and documenting confirmation to requirements see source doc verification (SDV)
|-
| CDISCglossary||protocol||verification. Verification usuallyconcerns confirmation that specifiedrequirements have been met, buttypically refers to the tracing ofrequirements and evidence ofconformance in the individual phasesor modules rather than suitability ofthe complete product. Validation is,“the evaluation of software at the endof the software development processto ensure compliance with the userrequirements” (ANSI/ASQC A3-1978)and should not be thought of as an end to end process
|-
| CDISCglossary||protocol||visit. A clinical encounter thatencompasses planned and unplannedtrial interventions, procedures andassessments that may be performed
|-
| CDISCglossary||role||volunteer. A person volunteering toparticipate as a subject in a clinicaltrial, often a healthy person agreeingto participate in a Phase 1 trial. See
|-
| CDISCglossary||role||vulnerable subjects. Individualswhose willingness to volunteer in aclinical trial may be unduly influencedby the expectation, whether justified
|-
| CDISCglossary||ducument||Warning Letter. A written
|-
| CDISCglossary||protocol||washout period. A period in a
|-
| CDISCglossary||computer||Web browser. A computer program
|-
| CDISCglossary||computer||Web page. A single page on a Web
|-
| CDISCglossary||computer||Web server. A computer server that
|-
| CDISCglossary||computer||Web site. A collection of Web pages
|-
| CDISCglossary||stats||weighting. An adjustment in a value
|-
| CDISCglossary||characteristic||well-being (of the trial subjects). The physical and mental integrity of the subjects participating
|-
| CDISCglossary||protocol||withdrawal. The act of reducing thedegree of participation by a subject in
|-
| CDISCglossary||other||within-subject differences. In acrossover trial, variability in eachsubject is used to assess treatmentdifferences.
|-
| CDISCglossary||computer||World Wide Web. All the resources
|-
| FCR||||1. Basic vs applied
|-
| FCR||||1. Hierarchical – show vertical relationships
|-
| FCR||quality||1. Morbidity
|-
| FCR||data||1. Outcome assessment
|-
| FCR||||1. Physical
|-
| FCR||protocol||1. Tradition (precedent)
|-
| FCR||study design||10. Historical research
|-
| FCR||quality||10. self-assessment of functional capacity
|-
| FCR||role||10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
|-
| FCR||||11. Propositions – state the relationships between variables
|-
| FCR||quality||11. quality of life
|-
| FCR||study design||11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
|-
| FCR||data model||12. Model – symbolic representation of the elements of a system
|-
| FCR||study design||12. Single-subject design
|-
| FCR||conclusion||13. Inductive theory – theory based on empirically verifiable observations
|-
| FCR||study design||13. Sequential clinical trial
|-
| FCR||study design||14. Evaluation research – assessment of the success of a program or policy
|-
| FCR||conclusion||14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
|-
| FCR||conclusion||15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
|-
| FCR||study design||15. Quasi-experimental research
|-
| FCR||protocol||16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
|-
| FCR||study design||16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
|-
| FCR||protocol||17. Deduction – theory testing
|-
| FCR||study design||17. Qualitative vs quantitative research
|-
| FCR||protocol||18. Induction – theory development
|-
| FCR||data||2. Acute conditions and chronic conditions
|-
| FCR||protocol||2. Authority (trusted expert)
|-
| FCR||quality||2. mortality
|-
| FCR||study design||2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
|-
| FCR||||2. Schematic
|-
| FCR||time||2. Temporal – order concepts in time and states a sequence of events
|-
| FCR||study design||3. Case study – description of one or more patients
|-
| FCR||data||3. length of stay
|-
| FCR||||3. Process
|-
| FCR||time||3. Quantitative – frequency or duration of a specific behavior
|-
| FCR||data||3. Sources of knowledge
|-
| FCR||protocol||3. Trial and error
|-
| FCR||study design||4. Developmental research – description of pattern of change over time
|-
| FCR||protocol||4. Logical reasoning - Deductive reasoning, Inductive reasoning
|-
| FCR||data||4. readmission
|-
| FCR||||4. Statistical
|-
| FCR||science||4. Types of research
|-
| FCR||study design||5. Normative research – establishing normal values
|-
| FCR||quality||5. Physical
|-
| FCR||protocol||5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
|-
| FCR||study design||6. Qualitative research – gathering data through interview or observation
|-
| FCR||quality||6. social
|-
| FCR||data model||6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
|-
| FCR||study design||7. Cohort or case-control studies – establish associations
|-
| FCR||hypothesis||7. Hypothesis - specific predictions based on a theory.
|-
| FCR||quality||7. psychological well-being
|-
| FCR||data||8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
|-
| FCR||study design||8. Methodological studies – establish reliability and validity of a new method
|-
| FCR||quality||8. Patient satisfaction
|-
| FCR||data||9. Constructs – concepts that represent non-observable behaviors or events
|-
| FCR||quality||9. patient preference
|-
| FCR||study design||9. Secondary analysis – exploring new relationships in old data
|-
| MUSC||data||accrual rate
|-
| MUSC||role||active control
|-
| MUSC||||adherence
|-
| MUSC||unscheduled||adjustment
|-
| MUSC||unscheduled||adverse event
|-
| MUSC||data||allocation ratio
|-
| MUSC||statistics||alternative hypothesis
|-
| MUSC||data||analysis datasets
|-
| MUSC||protocol||assessment
|-
| MUSC||statistics||assessment bias
|-
| MUSC||time||assessment schedule
|-
| MUSC||||as-treated
|-
| MUSC||protocol||auditing
|-
| MUSC||study design||balanced design
|-
| MUSC||||baseline
|-
| MUSC||||baseline comparability
|-
| MUSC||statistics||bias
|-
| MUSC||protocol||biased coin randomizaiton
|-
| MUSC||statistics||binormial
|-
| MUSC||quality||bioequivalence
|-
| MUSC||protocol||blinding
|-
| MUSC||role||block
|-
| MUSC||data||carryover effect
|-
| MUSC||document||case report
|-
| MUSC||document||case report form
|-
| MUSC||study design||case-control design
|-
| MUSC||protocol||censoring
|-
| MUSC||data||clinical trial management system
|-
| MUSC||protocol||cluster randomization
|-
| MUSC||protocol||coding
|-
| MUSC||role||cohort
|-
| MUSC||study design||community intervention trial
|-
| MUSC||quality||comparative treatment efficacy
|-
| MUSC||quality||complaince
|-
| MUSC||role||concurrent controls
|-
| MUSC||statistics||confidence interval
|-
| MUSC||study design||confirmatory trial
|-
| MUSC||role||confounder
|-
| MUSC||role||confounding factor
|-
| MUSC||document||CONSORT statement
|-
| MUSC||||constrain
|-
| MUSC||||context
|-
| MUSC||data||continous
|-
| MUSC||role||controls
|-
| MUSC||study design||crossover
|-
| MUSC||study design||crossover trial
|-
| MUSC||||cross-sectional analysis
|-
| MUSC||organization role||data and safety monitoring board
|-
| MUSC||document||data clarification query
|-
| MUSC||document||data clarification request
|-
| MUSC||time||data collection schedule
|-
| MUSC||protocol||data management
|-
| MUSC||protocol||data management plan
|-
| MUSC||organization role||data safety monitoring committee
|-
| MUSC||data||database
|-
| MUSC||protocol||data-dependent stopping
|-
| MUSC||data||derived data
|-
| MUSC||||deterministic
|-
| MUSC||study design||diagnostic trial
|-
| MUSC||||dichotomous
|-
| MUSC||data||discret
|-
| MUSC||conclusion||dose finding
|-
| MUSC||protocol||double blinding
|-
| MUSC||protocol||double masking
|-
| MUSC||unscheduled||dropouts
|-
| MUSC||quality||drug lot
|-
| MUSC||unscheduled||early termination
|-
| MUSC||quality||efficacy
|-
| MUSC||protocol||electronic data capture
|-
| MUSC||protocol||eligibility
|-
| MUSC||data||endpoint
|-
| MUSC||quality||equipoise
|-
| MUSC||study design||equivalence trials
|-
| MUSC||protocol||estimate
|-
| MUSC||protocol||evaluation
|-
| MUSC||organization role||excecutive committee
|-
| MUSC||protocol||exclusion criteria
|-
| MUSC||||expectation bias
|-
| MUSC||||experiment
|-
| MUSC||study design||factorial design
|-
| MUSC||protocol||follow-up
|-
| MUSC||||group sequential
|-
| MUSC||role||historic controls
|-
| MUSC||statistics||imbalance
|-
| MUSC||protocol||imputation of missing data
|-
| MUSC||protocol||inclusion criteria
|-
| MUSC||protocol||informed consent
|-
| MUSC||organization role||institutional review board
|-
| MUSC||protocol||intention to treat
|-
| MUSC||role||intention to treat population
|-
| MUSC||statistics||interaction
|-
| MUSC||protocol||interim analysis
|-
| MUSC||||intersubject
|-
| MUSC||role||intervention
|-
| MUSC||||intrasubject
|-
| MUSC||document||investigational new drug (IND) application
|-
| MUSC||quality||investigator competence
|-
| MUSC||||local control
|-
| MUSC||data||lost to follow-up
|-
| MUSC||statistics||main effect
|-
| MUSC||protocol||masking
|-
| MUSC||person role||medical safety monitor
|-
| MUSC||protocol||meta-analysis
|-
| MUSC||protocol||minimization randomization
|-
| MUSC||||minority representation
|-
| MUSC||data||missing data
|-
| MUSC||protocol||monitoring
|-
| MUSC||study design||multi-center
|-
| MUSC||study design||multi-site
|-
| MUSC||statistics||multivariable
|-
| MUSC||conclusion||negative findings
|-
| MUSC||statistics||nesting design
|-
| MUSC||document||new drug application (NDA)
|-
| MUSC||statistics||Neyman allocation
|-
| MUSC||unscheduled||nonadherence
|-
| MUSC||unscheduled||noncomplaince
|-
| MUSC||||noninferiority
|-
| MUSC||statistics||null hypothesis
|-
| MUSC||data||observation
|-
| MUSC||statistics||odds
|-
| MUSC||statistics||odds ratio
|-
| MUSC||statistics||one-sided test
|-
| MUSC||||optimal allocation
|-
| MUSC||quality||over-the -count (OTC)
|-
| MUSC||study design||parallel design
|-
| MUSC||protocol||permuted block randomization
|-
| MUSC||role||per-protocol population
|-
| MUSC||study design||phase I trial
|-
| MUSC||study design||phase II trial
|-
| MUSC||study design||phase IIA
|-
| MUSC||study design||phase IIB
|-
| MUSC||study design||phase IIB
|-
| MUSC||study design||phase III trial
|-
| MUSC||study design||phase IV trial
|-
| MUSC||study design||pivotal trials
|-
| MUSC||study design||placebo controlled
|-
| MUSC||protocol||play the winner
|-
| MUSC||role||plecabo
|-
| MUSC||aggregate||population
|-
| MUSC||conclusion||positive findings
|-
| MUSC||statistics||power
|-
| MUSC||study design||prevention trials
|-
| MUSC||||primary efficacy
|-
| MUSC||conclusion||primary outcome
|-
| MUSC||data||primary response
|-
| MUSC||person role||principal investigator
|-
| MUSC||role||prognostic factor
|-
| MUSC||protocol||project management
|-
| MUSC||protocol||project management plan
|-
| MUSC||protocol||protocal complaince
|-
| MUSC||protocol||protocol
|-
| MUSC||unscheduled||protocol exception
|-
| MUSC||unscheduled||protocol violation
|-
| MUSC||statistics||pseudorandom
|-
| MUSC||statistics||p-value
|-
| MUSC||protocol||quality assurance
|-
| MUSC||protocol||random play the winner
|-
| MUSC||protocol||recruitment
|-
| MUSC||protocol||regulatory management
|-
| MUSC||data||repeat measurement
|-
| MUSC||data||response
|-
| MUSC||protocol||response adaptive randomization
|-
| MUSC||study design||retrospective design
|-
| MUSC||quality||safety
|-
| MUSC||statistics||sample size
|-
| MUSC||||sample size inflation
|-
| MUSC||protocol||screening
|-
| MUSC||||selection bias
|-
| MUSC||study design||sequential design
|-
| MUSC||unscheduled||serious adverse event
|-
| MUSC||role||sham treatment
|-
| MUSC||study design||single-center
|-
| MUSC||study design||single-site
|-
| MUSC||document||source document
|-
| MUSC||person role||sponsor
|-
| MUSC||protocol||statistical analysis plan
|-
| MUSC||statistics||statistical significant
|-
| MUSC||organization role||steering committee
|-
| MUSC||protocol||stop rule
|-
| MUSC||statistics||stratification
|-
| MUSC||person role||study coordinator
|-
| MUSC||role||subject
|-
| MUSC||quality||superiority
|-
| MUSC||conclusion||surrogate outcome
|-
| MUSC||time||time to event
|-
| MUSC||protocol||titration
|-
| MUSC||quality||tocxicity
|-
| MUSC||quality||tolerability
|-
| MUSC||role||treatment
|-
| MUSC||||treatment allocation
|-
| MUSC||role||treatment group
|-
| MUSC||unscheduled||treatment-emergenet adverse event (TEAE)
|-
| MUSC||protocol||trilple blinding
|-
| MUSC||protocol||triple masking
|-
| MUSC||statistics||two-sided test
|-
| MUSC||statistics||type I error
|-
| MUSC||statistics||type II error
|-
| MUSC||statistics||univariable
|-
| MUSC||protocol||urn randomization
|-
| MUSC||||varibility
|-
| MUSC||time||washout period
|-
| MUSC||protocol||withdrawal consent
|-
| RCT||role||Analyzed population
|-
| RCT||time||Anchored-time
|-
| RCT||conclusion||Ancillary-outcome
|-
| RCT||data||Baseline
|-
| RCT||protocol||Blinding
|-
| RCT||protocol||Blinding-method
|-
| RCT||study design||Cointervention*
|-
| RCT||study design||Comparison-arm
|-
| RCT||quality||Cost
|-
| RCT||role||Crossover population
|-
| RCT||time||Date
|-
| RCT||||Device
|-
| RCT||time||Double-anchored-interval
|-
| RCT||role||Drug
|-
| RCT||protocol||Drug-step
|-
| RCT||time||Duration
|-
| RCT||role||Eligible-population
|-
| RCT||role||Enrolled-population
|-
| RCT||role||Excluded population
|-
| RCT||protocol||Exclusion-rule
|-
| RCT||protocol||Executed-protocol
|-
| RCT||protocol||Executed-secondary-study-protocol
|-
| RCT||study design||Experimental-arm
|-
| RCT||protocol||Follow-up activity
|-
| RCT||role||Funder
|-
| RCT||protocol||Inclusion-rule
|-
| RCT||organization||Institution
|-
| RCT||protocol||Intended-protocol
|-
| RCT||protocol||Intended-secondary-study-protocol
|-
| RCT||time||Interval
|-
| RCT||study design||Intervention*
|-
| RCT||study design||Intervention-arm
|-
| RCT||protocol||Intervention-step
|-
| RCT||role||Investigator
|-
| RCT||protocol||Non-drug-intervention-step
|-
| RCT||||No-treatment
|-
| RCT||data||Outcome
|-
| RCT||data||Outcomes-followup
|-
| RCT||role||Placebo
|-
| RCT||conclusion||Primary-outcome
|-
| RCT||protocol||Primary-recruitment-flowchart
|-
| RCT||protocol||Procedure
|-
| RCT||protocol||Protocol
|-
| RCT||unscheduled||Protocol-change
|-
| RCT||protocol||Protocol-concept
|-
| RCT||role||Randomized-population
|-
| RCT||||Reason
|-
| RCT||role||Recruited-population
|-
| RCT||protocol||Recruitment-flowchart
|-
| RCT||role||Screened-population
|-
| RCT||conclusion||Secondary-outcome
|-
| RCT||study design||Secondary-study
|-
| RCT||protocol||Secondary-study-protocol
|-
| RCT||data||Side-effect
|-
| RCT||time||Single-anchored-interval
|-
| RCT||role||Site-enrollment
|-
| RCT||protocol||Stopping-rule
|-
| RCT||role||Study-arm population
|-
| RCT||organization role||Study-committee
|-
| RCT||conclusion||Study-outcome
|-
| RCT||organization role||Study-site
|-
| RCT||time||Timepoint
|-
| RCT||time||Time-range
|-
| RCT||role||Treatment-assignment
|-
| RCT||||Trial
|-
| RCT||role||Trial-participant
|-
| RCT||data||Withdrawal-reason
|-
|
|}

File:CTO-terms-wAllCDISCglossary.xls

2007-05-09T20:43:05Z

Jalee:

OCI Term Compilation (Jennifer)

2007-05-09T20:41:51Z

Jalee:

Go back to [[CTO:Main Page]]

Download the term list here:
* May 3 term list [[Image:CTO-may3.xls]]
* May 9 term list

Some notes from Simona on the RCT terms as classified in the May 3 term list:
[[Image:CTO-may3-RCT.xls]]

Download term lists (above links) or view the May 9 term list here:

{| {{table}}
| align="center" style="background:#f0f0f0;"|'''source'''
| align="center" style="background:#f0f0f0;"|'''draft category'''
| align="center" style="background:#f0f0f0;"|'''term / definition'''
|-
| CDISCglossary||format||“adequate and well-controlled study”see 21CFR 314.126.
|-
| CDISCglossary||pharmacokinetics||absorption.
|-
| CDISCglossary||documents||action letter.
|-
| CDISCglossary||protocol||activation. event when an eClinical trial system is enabled for capturing data,
|-
| CDISCglossary||protocol||admission criteria.
|-
| CDISCglossary||unshceduled event||adverse drug experience. See adverse drug reaction.
|-
| CDISCglossary||unshceduled event||adverse drug reaction (ADR)
|-
| CDISCglossary||unshceduled event||adverse event (AE). Synonyms: side effect, adverse experience.
|-
| CDISCglossary||protocol||algorithm.
|-
| CDISCglossary||statistics||alpha error.
|-
| CDISCglossary||documents||amendment.
|-
| CDISCglossary||organization||American National Standards Institute (ANSI)
|-
| CDISCglossary||role||analysis set. A set of subjects whose data are to be included in the main analyses.
|-
| CDISCglossary||other||analysis variables.
|-
| CDISCglossary||computer||applet. A small application, typically downloaded from a server.
|-
| CDISCglossary||computer||application. 1. Computer application; 2. Regulatory application:
|-
| CDISCglossary||documents||application. 1. Computer application; 2. Regulatory application:
|-
| CDISCglossary||documents||application. 1. Computer application; 2. Regulatory application:
|-
| CDISCglossary||documents||approvable letter
|-
| CDISCglossary||protocol||approval
|-
| CDISCglossary||documents||approval letter,
|-
| CDISCglossary||documents||approval letter. An official communication from FDA
|-
| CDISCglossary||time||arm. A planned sequence of elements, typically equivalent to a treatment group. [SDTM]
|-
| CDISCglossary||protocol||assessment. A measurement, evaluation or judgment.
|-
| CDISCglossary||protocol||audit
|-
| CDISCglossary||documents||audit certificate
|-
| CDISCglossary||documents||audit report
|-
| CDISCglossary||data||audit trail
|-
| CDISCglossary||documents||background material.
|-
| CDISCglossary||statistics||balanced study.
|-
| CDISCglossary||property||bandwidth
|-
| CDISCglossary||protocol||baseline assessment
|-
| CDISCglossary||data||baseline characteristics. Data collected for each participant at the beginning
|-
| CDISCglossary||property||baseline imbalance. Systematic error in creating intervention groups
|-
| CDISCglossary||statistics||Bayesian approaches.
|-
| CDISCglossary||statistics||beta error.
|-
| CDISCglossary||statistics||bias.
|-
| CDISCglossary||protocol||bioanalytical assays. Methods for quantitative measurement of a drug, enzyme
|-
| CDISCglossary||pharmacokinetics||bioavailability. Rate and extent to which a drug is absorbed
|-
| CDISCglossary||pharmacokinetics||bioequivalence. Scientific basis on which drugs with the same active ingredient(s) are compared.
|-
| CDISCglossary||role||biological marker. See biomarker.
|-
| CDISCglossary||documents||Biologics Licensing Application (BLA). An application to FDA for a license to market
|-
| CDISCglossary||role||biomarker. A characteristic that is objectively measured and evaluated as
|-
| CDISCglossary||statistics||biostatistics. Branch of statistics applied to the analysis of biological phenomena.
|-
| CDISCglossary||protocol||blind review. Checking and assessing data prior to breaking the blind, for the purpose of
|-
| CDISCglossary||role||blinded (masked) medications. Products that appear identical in size,
|-
| CDISCglossary||study||blinded study. A study in which is unaware of the treatment assignment
|-
| CDISCglossary||protocol||blinding. Preventing identification of treatments/procedures/test to test. Masking, while often used synonymously with blinding, is usually associated with concealing the specific study intervention used. The term “masking” is often preferred in the field of ophthalmology.
|-
| CDISCglossary||property||brand name. See proprietary name. Synonyms: trade name; proprietary
|-
| CDISCglossary||computer||browser. Computer program that runs on the user’s desktop computer
|-
| CDISCglossary||computer||cache. Storage area on a computer’s hard drive where the browser stores
|-
| CDISCglossary||property||carry-over effect. Effects of treatment that persist after treatment has been stopped,
|-
| CDISCglossary||document||case history. An adequate and accurate record prepared and
|-
| CDISCglossary||document||case record form. See case report form.
|-
| CDISCglossary||document||case report form (CRF document designed to record all of the required information to be reported to the sponsor for each trial subject.
|-
| CDISCglossary||data||case report form 2. A record of clinical study observations and other information that a study
|-
| CDISCglossary||document||case report tabulations (CRT). In a paper submission, listings of data. See also eCRT.
|-
| CDISCglossary||data||categorical data. Data evaluated by sorting values (for example, severe,
|-
| CDISCglossary||data||causality assessment. An evaluation performed by a medical professional
|-
| CDISCglossary||ethics committee||CCI committee on clinical investigations
|-
| CDISCglossary||ethics committee||CCPPRB Comité Consultative pour la Protection des Personnes dans les
|-
| CDISCglossary||format||CDISC Standard (The). CDISC term for a proposed uniform CDISC standard intended to address the full life-cycle of a clinical trial including protocol representation, capture of source data, submission and archiving using a set of derived from the current set of CDISC standards.
|-
| CDISCglossary||document||certified copy
|-
| CDISCglossary||person role||Certified IRB Professional (CIP).
|-
| CDISCglossary||ethics committee||CHR committee on human research
|-
| CDISCglossary||data||clean database. A set of reviewed
|-
| CDISCglossary||computer||client. A program that makes a
|-
| CDISCglossary||quality||clinical benefit.
|-
| CDISCglossary||data / document||clinical clarification. A query resolution from the sponsor See also self-evident change.
|-
| CDISCglossary||data||clinical data. Data pertaining to the medical well-being or status of a subject.
|-
| CDISCglossary||document||clinical development plan. document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, NOTE: the plan should have appropriate decision points and allow modification as knowledge accumulates.
|-
| CDISCglossary||format||clinical document architecture. Specification for the structure and semantics for the purpose of exchange.
|-
| CDISCglossary||document||clinical document. A documentation of clinical observations and services.
|-
| CDISCglossary||other||clinical efficacy.
|-
| CDISCglossary||investigation||clinical investigation. See clinical trial.
|-
| CDISCglossary||science||clinical pharmacology.
|-
| CDISCglossary||protocol||clinical protocol. See protocol.
|-
| CDISCglossary||science||clinical research and development. The testing of a drug compound in humans
|-
| CDISCglossary||person role||clinical research associate (CRA).
|-
| CDISCglossary||person role||clinical research coordinator (CRC). handles most of the administrative responsibilities of a clinical trial on behalf of a site Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse.
|-
| CDISCglossary||quality||clinical significance. Change in a subject’s clinical condition regarded as important whether or not due to the test intervention. criteria for clinical significance should be stated in the protocol.
|-
| CDISCglossary||document||clinical study (trial) report. A
|-
| CDISCglossary||investigation||clinical study. See clinical trial.
|-
| CDISCglossary||data||clinical trial data. clinical trial information.
|-
| CDISCglossary||document||clinical trial exemption (CTX). allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA),
|-
| CDISCglossary||data||clinical trial information. Data collected in the course of a clinical trial
|-
| CDISCglossary||investigation||clinical trial. Any investigation in human subjects intended to discover or
|-
| CDISCglossary||data||clinician reported outcome. Clinician assessment of patient outcomes,
|-
| CDISCglossary||format||codelist. Finite list of codes and their meaning
|-
| CDISCglossary||protocol||cognitive debriefing. A tool used to determine whether concepts and items are understood by patients in the same way that PRO instrument developers
|-
| CDISCglossary||study||cohort study. Study of a group of individuals, some of whom are exposed
|-
| CDISCglossary||role / aggregate||cohort. 1. A group of individuals who share a common exposure, experience or characteristic. 2. A group of individuals traced in a cohort study.
|-
| CDISCglossary||property||combination product. 1. A product comprising two or more individual
|-
| CDISCglossary||format||Common Technical Document. A format agreed upon by ICH See also eCTD.
|-
| CDISCglossary||study||comparative study.
|-
| CDISCglossary||organization||Competent Authority (CA). The regulatory body charged with
|-
| CDISCglossary||data||complete file. File for which all data
|-
| CDISCglossary||protocol||completion. 1. Subject completion: 2. Study completion:
|-
| CDISCglossary||protocol||compliance (in relation to
|-
| CDISCglossary||computer||computer application. See application.
|-
| CDISCglossary||statistics||confidence interval.
|-
| CDISCglossary||other||confidentiality. Prevention of
|-
| CDISCglossary||study design||confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
|-
| CDISCglossary||trial||confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
|-
| CDISCglossary||document||consent form. Synonym: informed consent form; see also informedconsent.
|-
| CDISCglossary||person role||consumer safety officer (CSO). FDA official who coordinates the review
|-
| CDISCglossary||organization role||contract research organization
|-
| CDISCglossary||document||contract. A written, dated, and
|-
| CDISCglossary||role||control group. The group of subjects
|-
| CDISCglossary||role||control(s). 1. Comparator against which the study treatment is evaluated
|-
| CDISCglossary||study||controlled study. A study in whicha test article is compared with atreatment that has known effects. The
|-
| CDISCglossary||format||controlled vocabulary. A finite set
|-
| CDISCglossary||computer||controls 2 Computer: processes or operations intended to ensure authenticity, integrity, and confidentiality of electronic records.
|-
| CDISCglossary||role||coordinating committee
|-
| CDISCglossary||person role||coordinating investigator.
|-
| CDISCglossary||statistics||correlation.
|-
| CDISCglossary||other||covariate (prognostic). Factor or condition that influences outcome of a trial.
|-
| CDISCglossary||ethics committee||CPPHS committee for the protection of human subjects
|-
| CDISCglossary||ethics committee||CRB central review board
|-
| CDISCglossary||ducument||CRF (paper). Case report form See also eCRF, case report form.
|-
| CDISCglossary||study||crossover trial. A trial design for which subjects function as their own control
|-
| CDISCglossary||document||curriculum vitae (cv).
|-
| CDISCglossary||protocol||data acquisition. Capture of dataContrast with data entry, electronic data capture.
|-
| CDISCglossary||organization role||data and safety monitoring board (DSMB). See data monitoring committee.
|-
| CDISCglossary||document||data clarification form. A form used to query an investigator and collect feedback to resolve questions
|-
| CDISCglossary||protocol||data clarification. Answer supplied by the investigator in response to a
|-
| CDISCglossary||protocol or document||data collection instrument. A substrate or tool (either electronic or paper) used to record, transcribe orcollect clinical data
|-
| CDISCglossary||computer||data element. 1. For XML, an item
|-
| CDISCglossary||computer||data encryption standard (DES).
|-
| CDISCglossary||protocol||data entry. Human input of data
|-
| CDISCglossary||protocol||data integrity verification. Manual process
|-
| CDISCglossary||data quality||data integrity. An attribute of data
|-
| CDISCglossary||protocol||data interchange. Transfer of data, maintains integrity
|-
| CDISCglossary||data||data item. A named component of adata element. Usually the smallest
|-
| CDISCglossary||protocol||data management conventions.
|-
| CDISCglossary||protocol||data management. Tasks
|-
| CDISCglossary||data||data model. Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use.
|-
| CDISCglossary||organization||data monitoring committee
|-
| CDISCglossary||protocol||data monitoring. Process by which clinical data are examined for completeness, consistency, and accuracy.
|-
| CDISCglossary||data||data quality. Describes the characteristics that confirm “fitness for use”—that is, ability to support auditing. NOTE: Because assessments of data quality are linked to the needs of the study and expectations of the user, the quality criteria may vary from one project to another.
|-
| CDISCglossary||data||data security. Degree to which data are protected from the risk of accidental or malicious alteration or
|-
| CDISCglossary||protocol||data selection criteria. The rules
|-
| CDISCglossary||protocol||data transformations. Algorithmic
|-
| CDISCglossary||data||data type. Data types define the structural format of the data carried in the attribute and influence the set of allowable values an attribute may
|-
| CDISCglossary||protocol||data validation. 2. Process used to determine if data are inaccurate,incomplete, or unreasonable. The process may include format checks,completeness checks, check key tests,
|-
| CDISCglossary||protocol||data validation. 1. Checking data for correctness and/or compliance with applicable standards, rules, and
|-
| CDISCglossary||data||data. Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA]
|-
| CDISCglossary||protocol||database lock. Action taken to
|-
| CDISCglossary||data||database. A collection of data or
|-
| CDISCglossary||data||dataset. An organized collection of data or information with a common theme arranged in rows and columns
|-
| CDISCglossary||other||decision rule. Succinct statement of
|-
| CDISCglossary||document||Declaration of Helsinki. A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research
|-
| CDISCglossary||data||demographic data. Characteristics
|-
| CDISCglossary||statistics||dependent variable. Outcomes
|-
| CDISCglossary||statistics||derived variable. New variable
|-
| CDISCglossary||study design||design configuration. Clinical trial design developed to compare treatment groups in a clinical trial.Examples include: Parallel GroupDesign, Crossover Design, Factorial
|-
| CDISCglossary||plan||development plan. An ordered program of clinical trials, each with specific objectives.also clinical development plan
|-
| CDISCglossary||protocol||development process. See drug development process.
|-
| CDISCglossary||permission||direct access. Permission to examine, analyze, verify, and reproduce any records and reports that are important
|-
| CDISCglossary||protocol||discontinuation. The act of concluding participation, prior to completion of all protocol-requiredsubject NOTE: Four categories of discontinuation are distinguished: a)dropout: Active discontinuation by a discontinued subject); b) investigatorinitiated discontinuation (e.g., fo rcause); c) loss to follow-up: cessation cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation.
|-
| CDISCglossary||other||discrepancy. The failure of a datapoint to pass a validation check. NOTE:
|-
| CDISCglossary||other||disease. Any deviation from or interruption of the normal structure or function of a part, organ, or system of the body as manifested by characteristic symptoms and signs.
|-
| CDISCglossary||statistics||distribution. 1. In statistics, a group
|-
| CDISCglossary||pharmacokinetics||pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other
|-
| CDISCglossary||document||document (HL7). An ordered presentation of XML elements, possibly including text and tabular analyses,can be either physical (referring to the paper) or logical (referring to thecontent) with the followingcharacteristics: 1) Stewardship; 2)Potential for authentication; 3)Wholeness; 4) Human readability; 5)Persistence; 6) Global vs. local context.
|-
| CDISCglossary||computer||document root. The element in an XML document that contains all othe relements; the first element in the document.
|-
| CDISCglossary||format||document type definition (DTD).
|-
| CDISCglossary||document||documentation. All records, in any form (including, but not limited to,written, electronic, magnetic, andoptical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a
|-
| CDISCglossary||computer||domain name. The way a particular
|-
| CDISCglossary||quality||dosage form. Physical characteristicsof a drug product, (e.g., tablet,capsule, or solution) that contains adrug substance, generally
|-
| CDISCglossary||protocol||dosage regimen. The number ofdoses per given time period; theelapsed time between doses (for
|-
| CDISCglossary||quality||dosage strength. 1. Proportion of active substance to excipient, measured in units of volume or concentration. 2.The strength of a drug product. tells how much of the active ingredient is present in each dosage.
|-
| CDISCglossary||protocol||dosage. The amount of drugadministered to a patient or testsubject over the course of the clinicalstudy; a regulated administration ofindividual doses. [AMA Manual of
|-
| CDISCglossary||protocol||dose. The amount of drugadministered to a patient or testsubject at one time or the totalquantity administered. [AMA Manualof Style]
|-
| CDISCglossary||study||double-blind study. A study in
|-
| CDISCglossary||protocol||double-dummy. A technique forretaining the blind when administeringsupplies in a clinical trial, when the twotreatments cannot be made identical.
|-
| CDISCglossary||role||dropout. A subject in a clinical trialwho for any reason fails to continue inthe trial until the last visit orobservation required of him/her by the
|-
| CDISCglossary||protocol||drug development process. The
|-
| CDISCglossary||role||drug product. 1. A dosage form thatcontains an active drug ingredient orplacebo; 2. A finished dosage form asdescribed in regulations. [SPL Glossary]
|-
| CDISCglossary||computer||dynamic HTML. Collective term for a
|-
| CDISCglossary||ethics committee||EAB ethical advisory board
|-
| CDISCglossary||ethics committee||EC ethics committee
|-
| CDISCglossary||study||eClinical trial. Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access,exchange and archive data Syn eClinical study, eClinical investigation.
|-
| CDISCglossary||document||eCRF. 1. Auditable electronic record designed to capture information required by the clinical trial protocol to be reported to the sponsor on each trial subject. 2. A CRF in which related data items and their associated comments, notes, and signatures are linked electronically. NOTE: eCRFs may
|-
| CDISCglossary||document||eCRT. CRTs provided in electronic format for eSubmissions (electronic Submissions; FDA - SAS transport files; replaced by STDM
|-
| CDISCglossary||protocol||edit check. An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range or
|-
| CDISCglossary||data||effect. An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments.
|-
| CDISCglossary||quality||effectiveness. The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.
|-
| CDISCglossary||quality||efficacy. The capacity of a drug or treatment to produce beneficial effects
|-
| CDISCglossary||protocol||electronic data capture (EDC).
|-
| CDISCglossary||computer||electronic record. Any combination
|-
| CDISCglossary||computer||electronic signature. A computer
|-
| CDISCglossary||time||element. 1. In trial design, a basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.
|-
| CDISCglossary||computer||element2. A section of text in an XML
|-
| CDISCglossary||document||eMedical record. An electronic
|-
| CDISCglossary||data||endpoint. Variable that pertains to the efficacy or safety evaluations of a
|-
| CDISCglossary||protocol||enroll. To register or enter into a
|-
| CDISCglossary||aggregate population||enrollment (cumulative). Current enrollment as well as any ever-enrolled subjects who have ended participation.
|-
| CDISCglossary||aggregate||enrollment (current). Subjects actively continuing to participate in a
|-
| CDISCglossary||aggregate||enrollment (target). The number of subjects in a class or group intended to be enrolled in a trial.
|-
| CDISCglossary||aggregate||enrollment 2. The class of enrolled subjects in a clinical trial.
|-
| CDISCglossary||protocol||enrollment. 1. The act of enrolling
|-
| CDISCglossary||organization||Enterprise Vocabulary Services
|-
| CDISCglossary||time||epoch. An interval of time in the planned conduct of a study during which the treatment is consistent. Synonyms: period, cycle, phase, stage.
|-
| CDISCglossary||data||ePRO. PRO data initially captured electronically
|-
| CDISCglossary||quality||equipoise. A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.
|-
| CDISCglossary||study||equivalence trial. A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically primary objective of showing that the response to two or more treatments differs by an amount that is clinically
|-
| CDISCglossary||data||eSource data (electronic source data). Source data captured initially into a permanent electronic record used for the reconstruction and
|-
| CDISCglossary||document||eSource document (electronic
|-
| CDISCglossary||characteristic||established name. The official name of a drug substance.
|-
| CDISCglossary||organization||ethics committee. See institutional review board, independent ethics committee.
|-
| CDISCglossary||organization role||Ethics Committees
|-
| CDISCglossary||organization||European Medicines Agency (EMEA). The regulatory agency for EU
|-
| CDISCglossary||characteristic||evaluable (for efficacy and safety). Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in Efficacy/Safety
|-
| CDISCglossary||protocol||exclusion criteria. List of
|-
| CDISCglossary||pharmacokinetics||excretion. The act or process of eliminating waste products from the body
|-
| CDISCglossary||study||exploratory trial. Phase 1 or 2 trial during which the actions of a therapeutic intervention are assessed and measured. NOTE: Procedures in
|-
| CDISCglossary||computer||Extraction Transformation Load(ETL). A class of software applications for data extraction, transformation and loading that are used to implement
|-
| CDISCglossary||computer||File Transfer Protocol (FTP). A
|-
| CDISCglossary||doc||final report. A written description of
|-
| CDISCglossary||conclusion||finding. A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.
|-
| CDISCglossary||role||first subject in (FSI, FPI). The date and time the first subject is enrolled and randomized into a study. The
|-
| CDISCglossary||role||first subject screened. First subject who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial. who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
|-
| CDISCglossary||role||first subject treated. First subject who receives the test article or placebo in a clinical trial.
|-
| CDISCglossary||study||first-in-humans study. The first Phase 1 study in which the test product is administered to human beings. first-in-man study. See first-in humans study.
|-
| CDISCglossary||organization||Food and Drug Administration
|-
| CDISCglossary||document||Form. A collection of items and item groups for capturing and displaying clinical trial data.
|-
| CDISCglossary||statistics||frequentist methods. Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation.
|-
| CDISCglossary||protocol||frozen. Status of a database, file, or element that has been presumed to be in its final state pending “lock” and where further editing is prevented without “unfreezing.” NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from “locking”
|-
| CDISCglossary||role||functional roles (in a study). See role
|-
| CDISCglossary||characteristic||gender. Subject self-identification re: male/female
|-
| CDISCglossary||statistics||generalizability. The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. [ICH
|-
| CDISCglossary||characteristic||generic name. The drug identifying name to which all branded (proprietary) names for that indication are associated
|-
| CDISCglossary||conclusion||global assessment variable. A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator’s overall impression about the state or change in state of a subject.
|-
| CDISCglossary||document||glossary. A collection of specialized words or terms with their meanings.
|-
| CDISCglossary||standard||good clinical practice (GCP). A standard for the design, conduct,
|-
| CDISCglossary||standard||good clinical research practice(GCRP). Term sometimes used to describe GCP. See good clinical practice.
|-
| CDISCglossary||data||granularity. Refers to the size of an information unit in relation to a whole NOTE: Structuring “privileges” in electronic systems is said to be highly granular when each of many roles can differ in their capacity to act on electronic records.
|-
| CDISCglossary||study||group sequential design. A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests. [Center for
|-
| CDISCglossary||standard||harmonized standard. A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC).health authority. Synonym for regulatory authority. NOTE: used in the
|-
| CDISCglossary||organization||Health Level 7 (HL7). An ANSI accredited Standards Developing Organization (SDO) operating in the healthcare arena. NOTE: Level 7 refers to the highest level of the International Standards Organization’s (ISO)communications model for Open
|-
| CDISCglossary||role||healthcare provider. 1. One who directly or indirectly administers interventions that are designed to improve the physical or emotional status of patients. 2. A person licensed, certified or otherwise authorized or permitted by law to administer health
|-
| CDISCglossary||role||healthy volunteer. Subject (not a patient) in a clinical trial. NOTE: Usually healthy volunteers serve as subjects in Phase 1 trials.
|-
| CDISCglossary||ethics committee||HEX human experimentation committee
|-
| CDISCglossary||ethics committee||HSRC human subjects review committee
|-
| CDISCglossary||role||human subject. Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR50.3]. Synonym: subject/trial subject.
|-
| CDISCglossary||standard||Huriet Law. France’s regulations
|-
| CDISCglossary||computer||HyperText Markup Language
|-
| CDISCglossary||computer||hypertext. Links in a document that
|-
| CDISCglossary||hypothesis||hypothesis to test. In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value.
|-
| CDISCglossary||ethics committee||IEC independent ethics committee
|-
| CDISCglossary||role||impartial witness. A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who
|-
| CDISCglossary||protocol||inclusion criteria. The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. independent data monitoring
|-
| CDISCglossary||organization||independent data monitoring committee (IDMC). A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify,
|-
| CDISCglossary||organization||independent ethics committee(IEC). An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to
|-
| CDISCglossary||data||indication. A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. NOTE: Where such a benefit has been established and approved by regulatory authorities, the therapy is said to be approved for such
|-
| CDISCglossary||protocol||informed consent. An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. Informed consent is an ongoing, interactive process, rather than a onetime
|-
| CDISCglossary||organization||institution (medical). Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH]institutional review board (IRB). An independent body constituted of medical, scientific, and non-scientific
|-
| CDISCglossary||organization||institutional review board (IRB). An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among
|-
| CDISCglossary||protocol||instrument. A means to capture data (e.g., questionnaire, diary) plus all the information anddocumentation that supports its use.
|-
| CDISCglossary||standard||intention-to-treat. The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given.
|-
| CDISCglossary||statistics||interaction (qualitative and quantitative). The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (for example, the centre). A quantitative interaction
|-
| CDISCglossary||protocol||Interim analysis(es). Analysis comparing intervention groups at anytime before the formal completion of the trial, usually before recruitment is complete. [CONSORT Statement]interim analysis schedule. The time/information points at which
|-
| CDISCglossary||document||interim clinical trial/study report. A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH]internal consistency. Pertaining to data that do not include contradictions.
|-
| CDISCglossary||data quality||internal consistency. Pertaining to data that do not include contradictions.
|-
| CDISCglossary||computer||Internet service provider (ISP). A
|-
| CDISCglossary||computer||Internet. A global system of
|-
| CDISCglossary||computer||interoperability. Ability of two or more systems or components to exchange information and to use the information that has been exchanged.
|-
| CDISCglossary||other||interpretation of results. [from PRODraft Guidance] Compare to questionnaire, survey (see Comments on Draft PRO Guidance, April 4, 2006by ISOQoL, p. 8).intention-to-treat. The principle that asserts that the effect of a
|-
| CDISCglossary||quality||inter-rater reliability. The property of scales yielding equivalent results when used by different raters on different occasions.
|-
| CDISCglossary||role||intervention. The drug, device, therapy or process under investigation in a clinical trial which has an effect on outcome of interest in a study: e.g., health-related quality of life, efficacy, safety, pharmacoeconomics. Synonyms: therapeutic intervention, medical product. See also: test articles; devices;
|-
| CDISCglossary||role||investigational product. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
|-
| CDISCglossary||role||investigational treatment. An intervention under investigation in a clinical trial.
|-
| CDISCglossary||role||investigator. 1. A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. 2. The individual principal investigator. 2. The individual under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is See also sponsor-investigator.
|-
| CDISCglossary||||investigator/institution. An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
|-
| CDISCglossary||doc||investigator’s brochure. A compilation of the clinical and nonclinical data on the investigationalproduct(s) which is relevant to the study of the investigational product(s)in human subjects. item. 1. A representation of a clinical
|-
| CDISCglossary||ethics committee||IRB independent review board; institutional review board
|-
| CDISCglossary||data||item definition. 1. In a questionnaire or form to be completed in a clinical trial, the specification of a question and the specification of the format and semantics of the response.2. Formal specification of the properties of an item or field of data in an eClinical trial.
|-
| CDISCglossary||protocol||item generation. Establishing the content to be covered by the items in aPRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and
|-
| CDISCglossary||aggregate||item group definition. The specification in an eClinical Trial of a collection of items often clinically related to each other and useful to consider as an ensemble. NOTE: Item groups are likely to have greater granularity in analysis datasets using
|-
| CDISCglossary||data||item. 1. A representation of a clinical variable, fact, concept or instruction in a manner suitable for communication, interpretation or processing by humans or by automated means. NOTE: Items are collected together to form item groups. 2. An individual question, statement, or task that is evaluated by the patient to address a particular concept to be measured by a PRO instrument. [1. CDISC. 2. from PRO item definition. 1. In a questionnaire or form to be completed
|-
| CDISCglossary||other||Janus. 1. A logical design conceived by Dr. Norman Stockbridge of the FDA for a data warehouse intended to integrate submission data, protocol descriptions and analysis plans from clinical and animal studies into as an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining and retrospective comparative analysis. 2) the name assigned to a component of the NCI’s CaBIG Clinical Research Information Exchange (CRIX)
|-
| CDISCglossary||document||label. Description of a drug product/device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities[FDA; SPL] Synonyms: package insert,
|-
| CDISCglossary||organization||laboratory (clinical). A laboratory providing analyses of samples collected in clinical care or research.
|-
| CDISCglossary||time||last subject out/complete(LSC/LPC or LSO/LPO). 1. The date and time when the last subject has reached a planned or achieved milestone representing the completion of the trial. 2. The last subject to complete a trial. See also subject, pt, completion
|-
| CDISCglossary||||
|-
| CDISCglossary||time||legal authentication. A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document.
|-
| CDISCglossary||role||legally acceptable representative. An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject\'s participation in the clinical trial. [ICH, E6 Glossary]
|-
| CDISCglossary||role||Leiter der klinischen Prüfung.Under the German Drug Law, the physician who is head of the clinical investigation
|-
| CDISCglossary||unscheduled||life-threatening adverse event/experience. Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred event/experience. Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death. [FDA 21 CFR §312.32;ICH-E2A]
|-
| CDISCglossary||study||longitudinal study. Investigation in which data are collected from a number of subjects over a long period of time
|-
| CDISCglossary||ethics committee||LREC local research ethics committees (UK)
|-
| CDISCglossary||study||marketing support trials. Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decisionmakers the rationale for preferring one therapy over another.
|-
| CDISCglossary||computer||markup. Computer-processable annotations within a multimedia document. NOTE: In the context of the HL7specification, markup syntax is according to the XML Specification.
|-
| CDISCglossary||study||masking. See blinding.
|-
| CDISCglossary||study||matched-pair design. A type of parallel trial design in which investigators identify pairs of subjects who are “identical” with respect to relevant factors, then randomize them so that one receives Treatment A and the other Treatment B. See also pairing.
|-
| CDISCglossary||study||matching. See pairing.
|-
| CDISCglossary||statistics||mean. The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.
|-
| CDISCglossary||statistics||median. The middle value in a dataset; that is, just as many values are greater than the median and lower than the median value.
|-
| CDISCglossary||role||medical monitor. A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.medical product. See intervention.
|-
| CDISCglossary||role||medicinal product. Synonym for therapeutic intervention, but usually a drug.
|-
| CDISCglossary||organization||Medicines and Healthcareproducts Regulatory Agency(MHRA). The UK government agencyresponsible for ensuring thatmedicines and medical devices work,and are acceptably safe.
|-
| CDISCglossary||study||mega-trials. Massive clinical trialsthat test the advantages oftherapeutic interventions by enrolling10,000 or more subjects. Synonym:large sample trials.
|-
| CDISCglossary||document||Memorandum ofUnderstanding (MOU). A MOUbetween FDA and another regulatoryagency allows mutual recognition ofinspections.
|-
| CDISCglossary||data||message (HL7). The atomic unit ofdata transferred between systems. Itcomprises a group of segments in adefined sequence. Each message has amessage type that defines its purpose. For example, the Admission,Discharge and Transfer (ADT) Message
|-
| CDISCglossary||protocol||meta-analysis. The formalevaluation of the quantitativeevidence from two or more trialsbearing on the same question. NOTE:This most commonly involves thestatistical combination of summarystatistics from the various trials, but
|-
| CDISCglossary||pharmacokinetics||metabolism. The biochemicalalteration of substances introducedinto the body
|-
| CDISCglossary||data||metadata. Data that describe otherdata, particularly XML tagscharacterizing attributes of values inclinical data fields.
|-
| CDISCglossary||computer||migration. The act of moving a system or software product (including data) from an old to new operational environment in accordance with a software quality system
|-
| CDISCglossary||data role||missing data. 1. Data notcompleted, or corrupted in reports andcase report forms. 2. Particularly thedata not captured when a subjectwithdraws from a trial.
|-
| CDISCglossary||statistics||mode. The most frequently occurringvalue in a data set.model. A formal structure forrepresenting and analyzing a processsuch as a clinical trial or theinformation pertaining to a restrictedcontext, e.g., clinical trial data. [CDISC]
|-
| CDISCglossary||data model||model. A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context, e.g., clinical trial data.
|-
| CDISCglossary||computer||modem. From modulator/demodulator; a device that converts digital data into analog data that can be transmitted via telephone or cable lines used for communications. monitor. Person employed by the sponsor or CRO who is responsible for
|-
| CDISCglossary||role||monitor. Person employed by thesponsor or CRO who is responsible fordetermining that a trial is beingconducted in accordance with theprotocol and GCP guidance. NOTE: Amonitor’s duties may include, but arenot limited to, helping to plan and
|-
| CDISCglossary||organization||monitoring committee. Seeindependent data-monitoringcommittee.
|-
| CDISCglossary||document||monitoring report. A written reportfrom the monitor to the sponsor aftereach site visit and/or other trial-relatedcommunication according to thesponsor’s SOPs.
|-
| CDISCglossary||protocol||monitoring visit. A visit to a studysite to review the progress of a clinicalstudy and to ensure protocoladherence, accuracy of data, safety ofsubjects, and compliance withregulatory requirements and goodclinical practice guidelines. [from ICH
|-
| CDISCglossary||protocol||monitoring. The act of overseeingthe progress of a clinical trial, and ofensuring that it is conducted, recorded,and reported in accordance with theprotocol, standard operating procedures(SOPs), good clinical practice(GCP), and the applicable regulatory
|-
| CDISCglossary||ethics committee||MREC multicentre research ethics committees (UK)
|-
| CDISCglossary||study||multicenter study. See multicenter trial.
|-
| CDISCglossary||study||multicenter trial. Clinical trialconducted according to a singleprotocol but at more than one site,and, therefore, carried out by morethan one investigator. [ICH E9 Glossary]Synonym: multicenter study; seeinvestigator/institution.
|-
| CDISCglossary||computer||natural language. Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines.
|-
| CDISCglossary||document||New Drug Application (NDA). Anapplication to FDA for a license tomarket a new drug in the UnitedStates.n-of-1 study. A trial in which anindividual subject is administered atreatment repeatedly over a number of
|-
| CDISCglossary||ethics committee||NIRB noninstitutional review board
|-
| CDISCglossary||study||n-of-1 study. A trial in which anindividual subject is administered atreatment repeatedly over a number ofepisodes to establish the treatment’seffect in that person, often with theorder of experimental and controltreatments randomized.
|-
| CDISCglossary||study||nonclinical study. Biomedicalstudies not performed on humansubjects.
|-
| CDISCglossary||document||not approvable letter. An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.
|-
| CDISCglossary||organization||Notified Body (NB). A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB.
|-
| CDISCglossary||ethics committee||NRB noninstitutional review board, also known as an independent review board
|-
| CDISCglossary||statistics||null hypothesis. The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. NOTE: A null hypothesis (for
|-
| CDISCglossary||document||Nuremberg Code. Code of ethics, set forth in 1947, for conducting human medical research. objective. The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing).
|-
| CDISCglossary||data||objective measurement. A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment. See also outcome, patient-reported outcome;
|-
| CDISCglossary||data||observation. 1. An assessment of patient condition or analysis of data collected on an individual patient or group of patients. 2. (SDTM) A discrete piece of information collected during a study.
|-
| CDISCglossary||data||observer assessment. An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.). NOTE: Distinguished from self-assessment. The observer relies on his or her judgment to assess the subject. An
|-
| CDISCglossary||trigger||open to enrollment. The status of a study such that a subject can be enrolled into that study.
|-
| CDISCglossary||study design||open-label study. A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding. open to enrollment. The status of a study such that a subject can be
|-
| CDISCglossary||standard||operational model. The set of CDISC data standards (including ODMand LAB) used to capture and archive data from clinical trials.
|-
| CDISCglossary||document||opinion (in relation to independent ethics committee). The judgment and/or the advice provided by an independent ethics committee.
|-
| CDISCglossary||metadata||origin. 1) Source of information collected in the course of a clinical trial. Specifically used to differentiate between data collected at point of patient contact and data that are derived or calculated. 2) (SDTM) A metadata attribute defined for each dataset variable in the “Define\" document of an SDTM submission that refers to the source of a variable (e.g.,CRF, derived, sponsor defined, PRO,etc.).
|-
| CDISCglossary||evidence code||original data. Those values that represent the first recording of study data. [CSUCT Definitions]outcome (of adverse event). Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology
|-
| CDISCglossary||data||outcome (of adverse event). Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved, recovering/ resolving, not recovered/not resolved, recovered /resolved with sequelae, fatal, or unknown
|-
| CDISCglossary||data||outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective
|-
| CDISCglossary||other||outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective
|-
| CDISCglossary||science||outcomes research. Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions.
|-
| CDISCglossary||statistics||outliers. Values outside of an expected range. packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to
|-
| CDISCglossary||mixed||packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.
|-
| CDISCglossary||protocol||pairing. A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B. See also matched-pair design.
|-
| CDISCglossary||study||parallel trial. Subjects are randomized to one of two or more differing treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. Synonyms: parallel group trial, parallel design trial
|-
| CDISCglossary||statistics||parameter. A variable in a model, or a variable that wholly or partially characterizes a probability distribution mathematics and statistics). NOTE: In clinical trials the term is often used synonymously with “variable” for factual information (age, date of
|-
| CDISCglossary||role||participant. A person or entity with a role in healthcare or a clinical study.NOTE: Participants in a clinical trial may include subjects and study personnel. A subject participates as part of the group of people who are administered the therapeutic intervention or control.
|-
| CDISCglossary||document||patient file. One that contains demographic, medical, and treatment information about a patient or subject. It may be paper- or computer-based or a mixture of computer and paperrecords.
|-
| CDISCglossary||document||patient package leaflet. labeling (content of). All text, tables and figures in labeling as described in regulations for a specific product
|-
| CDISCglossary||role||patient. Person under a physician\'s care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. See also subject, trial subject, healthy volunteer. Often used interchangeably
|-
| CDISCglossary||evidence code||patient-reported outcome (PRO).Report coming directly from patients or subjects through interviews or selfcompleted questionnaires or other data capture tools such as diaries about their life, health condition(s) and treatment. NOTE: subjective measurement
|-
| CDISCglossary||data||patient-reported outcome; objective measures are observations (SDTM) and could be endpoints. Patient-reported outcomes are subjective measurements.
|-
| CDISCglossary||data||permanent data. Data that become or are intended to become part of an electronic record in relation to a regulatory submission. Any changes made to such permanent data are recorded via an audit trail so that prior values are not obscured.
|-
| CDISCglossary||role||per-protocol analysis set. The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.
|-
| CDISCglossary||pharmacokinetics||pharmacodynamics. Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents.pharmacoeconomics. Branch of
|-
| CDISCglossary||pharmacokinetics||pharmacoeconomics. Branch of economics that applies cost-benefit, cost-utility, cost-minimization, and cost-effectiveness analyses to assess the utility of different pharmaceutical products or to compare drug therapy to other treatments.
|-
| CDISCglossary||protocol||pharmacogenetic test. An assay intended to study inter individual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.
|-
| CDISCglossary||pharmacokinetics||pharmacogenetics. Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.pharmacogenomic test. An assay intended to study interindividual variations in whole genome or
|-
| CDISCglossary||protocol||pharmacogenomic test. An assay intended to study interindividual variations in whole genome or candidate gene maps, biomarkers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response. Compare to pharmacogenetic test.pharmacogenomics. Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to
|-
| CDISCglossary||pharmacokinetics||pharmacogenomics. Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to predict whether a person will respond favorably, adversely, or not at all to an investigational product.
|-
| CDISCglossary||pharmacokinetics||pharmacokinetics. Study of the processes of bodily absorption, distribution, metabolism, and excretion(ADME) of medicinal products. pharmacology. Science that deals with the characteristics, effects, and uses of drugs and their interactions
|-
| CDISCglossary||pharmacokinetics||pharmacology. Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.pharmacovigilance. Term used for adverse event monitoring and reporting.
|-
| CDISCglossary||phase||pharmacovigilance. Term used for adverse event monitoring and reporting.phase. Clinical trials are generally categorized into four (sometimes five) phases described below. A therapeutic intervention may be evaluated in two
|-
| CDISCglossary||study||Phase 1. The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted inpatients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
|-
| CDISCglossary||study||Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug
|-
| CDISCglossary||study||Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit–risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3studies usually include from several
|-
| CDISCglossary||study||Phase 3b. A subcategory of Phase 3trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval.
|-
| CDISCglossary||study||Phase 4. Postmarketing (Phase 4)studies to delineate additional information about the drug’s risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but
|-
| CDISCglossary||study||Phase 5. Postmarketing surveillance is sometimes referred to as Phase 5. See also outcomes research. placebo. A pharmaceutical preparation that does not contain the investigational agent. In blinded studies, it is generally prepared to be
|-
| CDISCglossary||study design||phase. Clinical trials are generally categorized into four (sometimes five) phases A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
|-
| CDISCglossary||role||placebo. A pharmaceutical preparation that does not contain the investigational agent. In blinded studies, it is generally prepared to be physically indistinguishable from the preparation containing the investigational product.
|-
| CDISCglossary||aggregate||population. Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled.
|-
| CDISCglossary||protocol||post marketing surveillance. Ongoing safety monitoring of marketed drugs. See also Phase 4studies, Phase 5 studies. pragmatic trial. Term used to describe a clinical study designed to examine the benefits of a product
|-
| CDISCglossary||study||pragmatic trial. Term used to describe a clinical study designed to examine the benefits of a product under real world conditions. preclinical studies. Animal studies that support Phase 1 safety and tolerance studies and must comply
|-
| CDISCglossary||study||preclinical studies. Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP).NOTE: Data about a drug’s activities and effects in animals help establish boundaries for safe use of the drug in
|-
| CDISCglossary||document||Pre-Market Approval Application (PMA). An application to FDA for a license to market a new device in the United States. primary objective. The primaryobjective(s) is the main question to be answered and drives any statistical
|-
| CDISCglossary||role||primary variable. An outcome of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions.
|-
| CDISCglossary||role||product. 1. Drug product: A finished dosage form that contains a drug substance. 2. A physical entity that is intended to diagnose, treat, or prevent a disease or other abnormal condition, and subject to regulatory authority
|-
| CDISCglossary||organization||PROMIS. NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function and emotional well-being. [NIH]proprietary name. A commercial
|-
| CDISCglossary||characteristic||proprietary name. A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL] Synonyms: trade name, brand name. prospective study. Investigation in which a group of subjects is recruited
|-
| CDISCglossary||study||prospective study. Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol. protocol. A document that describes the objective(s), design, methodology, statistical considerations, and
|-
| CDISCglossary||document||protocol amendment(s). A written description of a change(s) to or formal clarification of a protocol. [ICH E3]protocol approval (Sponsor). Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer
|-
| CDISCglossary||protocol||protocol approval (Sponsor). Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated
|-
| CDISCglossary||unscheduled||protocol deviation. A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor
|-
| CDISCglossary||characteristic||Protocol Identifying Number. Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers
|-
| CDISCglossary||document||protocol referenced documents. Protocol referenced documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [from ICH E61.44] See also protocol.
|-
| CDISCglossary||characteristic||protocol violation. A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per protocol analysis, and may require that the subject (s) who violate the protocol
|-
| CDISCglossary||unscheduled||protocol violation. A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per protocol analysis, and may require that the subject(s) who violate the protocol
|-
| CDISCglossary||document||protocol. A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocoldocuments.NOTE: Present usage can refer to any of three distinct entities: 1)the plan (i.e., content) of a protocol, 2)the protocol document and 3) a series of tests or treatments (as in oncology).
|-
| CDISCglossary||protocol||protocolauthority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that maybe located at the site of the trial, at the
|-
| CDISCglossary||data||proxy (as an origin of outcome measures). A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures. Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO)directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. [CDISC (extension
|-
| CDISCglossary||person role||proxy respondent. Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. Compare to observer assessment.
|-
| CDISCglossary||other||psychometric reliability. See reliability, psychometric.
|-
| CDISCglossary||protocol||psychometric validation. The specialized process of validating questionnaires used in outcomes research to show that they measure what they purport to measure. NOTE: Several types of validity are distinguished. For example, face validity means that an assessment instrument appears by inspection and consideration of the semantic content of items in it to be measuring what it is supposed to measure. Construct validity means that a scale based on one or more items measures an unobservable psychological construct(e.g., “distress”) that it is proposed to measure. Construct validity is usually tested by measuring the correlation in assessments obtained from several scales purported to measure the same construct. [Guyatt et al., 1993; DIA
|-
| CDISCglossary||science||psychometrics. The science of assessing the measurement characteristics of scales that assess human psychological characteristics.
|-
| CDISCglossary||statistics||p-value. Study findings can also be
|-
| CDISCglossary||statistics||qualitative variable. One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes.
|-
| CDISCglossary||protocol||quality assurance (QA). All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable
|-
| CDISCglossary||protocol||quality control (QC). The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.[ICH]
|-
| CDISCglossary||quality||quality of life. A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationships to salient features of the environment.
|-
| CDISCglossary||statistics||quantitative variable. One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum. query. A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or
|-
| CDISCglossary||protocol||query management. Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data. query resolution. The closure of a query usually based on information
|-
| CDISCglossary||protocol||query resolution. The closure of a query usually based on information contained in a data clarification. questionnaire. A set of questions or items shown to a respondent in order to get answers for research purposes.[PRO Draft Guidance] See also
|-
| CDISCglossary||document||query. A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.
|-
| CDISCglossary||document assay||questionnaire. A set of questions or items shown to a respondent in order to get answers for research purposes.[PRO Draft Guidance] See also instrument, survey.
|-
| CDISCglossary||protocol||random allocation. Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: In a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.
|-
| CDISCglossary||statistics||random number table. Table of numbers with no apparent pattern used in the selection of random samples for clinical trials. random sample.
|-
| CDISCglossary||role||random sample. Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection. randomization. The process of assigning trial subjects to treatment or
|-
| CDISCglossary||protocol||randomization. The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects maybe assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balancedstudy.raw data. Data as originally collected.
|-
| CDISCglossary||data||raw data. Data as originally collected. Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments)
|-
| CDISCglossary||organization||RCRIM. Regulated Clinical Research and Information Management, which is a Technical Committee within HL7 (an acronym pronounced “arcrim”).
|-
| CDISCglossary||ethics committee||REB research ethics board (Canada)
|-
| CDISCglossary||ethics committee||Recherches Biomédicales (France)
|-
| CDISCglossary||protocol||reconstruction (of a study). For eClinical trials FDA expects archival trial records to support review of the data
|-
| CDISCglossary||protocol||recruitment (investigators).Process used by sponsors to identify,select and arrange for investigators toserve in a clinical study.
|-
| CDISCglossary||protocol||recruitment (subjects). Processused by investigators to find and enrollappropriate subjects (those selected onthe basis of the protocol’s inclusion andexclusion criteria) into a clinical study.
|-
| CDISCglossary||time||recruitment period. Time period during which subjects are or are planned to be enrolled in a clinical trial.
|-
| CDISCglossary||protocol||recruitment target. Number ofsubjects that must be recruited ascandidates for enrollment into a studyto meet the requirements of theprotocol. In multicenter studies, eachinvestigator has a recruitment target.Reference Information Model
|-
| CDISCglossary||data model||Reference Information Model(RIM). An information model used as the ultimate defining reference for al lHL7 standards.
|-
| CDISCglossary||data||registry. A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
|-
| CDISCglossary||organization or role||regulatory authorities. Bodieshaving the power to regulate. NOTE: Inthe ICH GCP guideline the termincludes the authorities that reviewsubmitted clinical data and those thatconduct inspections. These bodies aresometimes referred to as competent
|-
| CDISCglossary||quality||reliability, psychometric. The degree to which a psychometric “instrument” is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time
|-
| CDISCglossary||other||reliability, psychometric. Thedegree to which a psychometric“instrument” is free from random erroreither by testing the homogeneity ofcontent on multi-item tests withinternal consistency evaluation ortesting the degree to which theinstrument yields stable scores over time
|-
| CDISCglossary||protocol||replacement. The act of enrolling aclinical trial subject to compensate forthe withdrawal of another.representative. See legallyacceptable representative.research hypothesis. Theproposition that a study sets out to
|-
| CDISCglossary||role||representative. See legallyacceptable representative.
|-
| CDISCglossary||hypothesis||research hypothesis. The proposition that a study sets out to support (or disprove); for example,“blood pressure will be lowered by[specific endpoint] in subjects who receive the test product.” See also null hypothesis.
|-
| CDISCglossary||data||Researcher’s records of subjects/patients, such as patient medical charts, hospital records, X-rays,and attending physician’s notes. NOTE:These records may or may not accompany an application to a Regulatory Authority, but must be kept
|-
| CDISCglossary||document||result synopsis. The brief reportprepared by biostatisticianssummarizing primary (and secondary)efficacy results and key demographicinformation.
|-
| CDISCglossary||study||retrospective. Capture of clinicaltrial data is retrospective when it isrecalled from memory rather thancaptured contemporaneously in realtime.NOTE: Retrospective capture isimportant in PROs because of “recallbias” and other errors documented in
|-
| CDISCglossary||quality||risk. In clinical trials, the probability of harm or discomfort for subjects. NOTE:Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat,for example, will be expected to have a low incidence of troubling side effects.
|-
| CDISCglossary||role||role. 1. The function or responsibilityassumed by a person in the context ofa clinical study. Examples include datamanager, investigator. 2. Classifier forvariables that describe “observations”in the SDTM. Role is a metadataattribute that determines the type ofinformation conveyed by anobservation-describing variable andstandardizes rules for using thedescribing variable. [1. HL7. 2. SDTM]See also functional role.safety. Relative freedom from harm.
|-
| CDISCglossary||quality||safety and tolerability. The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs andsymptoms), and other special safetytests (e.g., ECGs, ophthalmology). The tolerability of the medical productrepresents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]
|-
| CDISCglossary||quality||safety. Relative freedom from harm.In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests andprocedures, psychiatric evaluation,
|-
| CDISCglossary||protocol||sample size adjustment. Aninterim check conducted on blindeddata to validate the sample sizecalculations or re-evaluate thesample size.screen failure. Potential subject whodid not meet one or more criteria
|-
| CDISCglossary||statistics||sample size. 1. A subset of a largerpopulation, selected for investigationto draw conclusions or make estimatesabout the larger population. 2. Thenumber of subjects in a clinical trial. 3.Number of subjects required forprimary analysis.
|-
| CDISCglossary||role||screen failure. Potential subject whodid not meet one or more criteriarequired for participation in a trial. Seealso screening of subjects.screen/screening (ofsubstances). Screening is the processby which substances are evaluated in a
|-
| CDISCglossary||protocol||screen/screening (ofsubstances). Screening is the processby which substances are evaluated in abattery of tests or assays (screens)designed to detect a specific biologicalproperty or activity. It can be conductedon a random basis in which substances
|-
| CDISCglossary||protocol||screening (of sites). Determiningthe suitability of an investigative siteand personnel to participate in aclinical trial.screening (of subjects). A processof active consideration of potentialsubjects for enrollment in a trial. See
|-
| CDISCglossary||protocol||screening (of subjects). A processof active consideration of potentialsubjects for enrollment in a trial. Seealso screen failure.
|-
| CDISCglossary||study||screening trials. Trials conducted todetect persons with early, mild andasymptomatic disease.script. A program or a sequence ofinstructions that are interpreted orcarried out by another program or bya person.
|-
| CDISCglossary||computer||script. A program or a sequence of instructions that are interpreted or carried out by another program or by a person. secondary objective. See objective. secondary variable. The primary outcome is the outcome of greatest
|-
| CDISCglossary||study||See also blinding/masking, double-blind study, single-blind study, triple-blind study; contrast with open-label or unblinded study.
|-
| CDISCglossary||unshceduled event||See also serious adverse event, serious adverse experience.
|-
| CDISCglossary||||semantic. In the context of a technical specification, semantic refers to the meaning of an element asdistinct from its syntax. Syntax canchange without affecting semantics.
|-
| CDISCglossary||unscheduled||serious adverse event (SAE) orserious adverse drug reaction(serious ADR). Any untowardmedical occurrence that at any dose:results in death, is life threatening,requires inpatient hospitalization orprolongation of existing hospitalization,
|-
| CDISCglossary||unscheduled||serious adverse experience. Anyexperience that suggests a significanthazard, contra-indication, side effect orprecaution. See also serious adverseevent.server. A computer that controls acentral repository of data, files and/or
|-
| CDISCglossary||computer||server. A computer that controls a central repository of data, files and/or applications that can be accessed and/or manipulated in some manner by client computers. A
|-
| CDISCglossary||characteristic||sex. Maleness or femaleness, as defined by chromosomal makeup. See also gender. side effects. Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea,
|-
| CDISCglossary||unscheduled||side effects. Any actions or effectsof a drug or treatment other than theintended effect. Negative or adverseeffects may include headache, nausea,hair loss, skin irritation, or otherphysical problems. Experimental drugsmust be evaluated for both immediate
|-
| CDISCglossary||study design||single-blind study. A study in which one party, either the investigatoror the subject, does not know which medication or placebo is administered to the subject; also called single masked study. See also blind study,double-blind study, triple-blind study.
|-
| CDISCglossary||protocol||software validation. Confirmationby examination and provision ofobjective evidence that softwarespecifications conform to user needsand intended uses, and that theparticular requirements implementedthrough software can be consistently
|-
| CDISCglossary||computer||software. Computer programs,procedures, rules, and any associated documentation pertaining to the operation of a system.software validation.
|-
| CDISCglossary||protocol||source data verification. Theprocess of ensuring that data that havebeen derived from source dataaccurately represent the source data.source document verification.The process by which the informationreported by an investigator is comparedwith the original records to ensure thatit is complete, accurate and valid.[Schuyl and Engel, 1999; Khosla et al.,Indian J. Pharm 32:180–186, 2000]Synonym: SDV. See also validation ofdata.
|-
| CDISCglossary||data||source data. All information in original records and certified copies of original records of clinical findings,observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
|-
| CDISCglossary||document||source documents. Originaldocuments, data, and records (e.g.,hospital records, clinical and officecharts, laboratory notes, memoranda,subjects’ diaries or evaluationchecklists, pharmacy dispensingrecords, recorded data from automated
|-
| CDISCglossary||population||special populations. Subsets ofstudy populations of particular interestincluded in clinical trials to ensure thattheir specific characteristics areconsidered in interpretation of data[e.g., geriatric].
|-
| CDISCglossary||human role||sponsor. 1. An individual, company,institution, or organization that takes responsibility for the initiation,management, and/or financing of aclinical trial. 2. A corporation or agencywhose employees conduct the investigation is considered a sponsor; employees are considered investigators
|-
| CDISCglossary||human role||sponsor-investigator. An individualwho both initiates and conducts, aloneor with others, a clinical trial, andunder whose immediate direction theinvestigational product is administeredto, dispensed to, or used by a subject.NOTE: The term does not include any person other than an individual, hence not a corporation, agency
|-
| CDISCglossary||statistics||standard deviation. Indicator of the relative variability of a variable around its mean; the square root of the variance.
|-
| CDISCglossary||standard||standard of care. A guideline for medical management and treatment.
|-
| CDISCglossary||plan||standard operating procedures(SOPs). Detailed, written instructions to achieve uniformity of the performance of a specific function
|-
| CDISCglossary||reference||standard treatment. A treatment currently in wide use and approved by the FDA or other health authority,considered to be effective in the treatment of a specific disease or condition.
|-
| CDISCglossary||plan||statistical analysis plan. Adocument that contains a moretechnical and detailed elaboration ofthe principal features of the analysisdescribed in the protocol, and includesdetailed procedures for executing thestatistical analysis of the primary and secondary variables and other data
|-
| CDISCglossary||protocol||statistical method. The particular mathematical tests and techniques that are to be used to evaluate the clinicaldata in a trial.
|-
| CDISCglossary||statistics||statistical significance. State tha tapplies when a hypothesis is rejected.Whether or not a given result is significant depends on the significance level adopted.
|-
| CDISCglossary||statistics||stochastic. Involving a randomvariable; involving chance orprobability.
|-
| CDISCglossary||protocol||stopping rules. A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great
|-
| CDISCglossary||standard||structured product label (SPL).The Structured Product Labeling (SPL)specification is an HL7 ANSI-approveddocument markup standard thatspecifies the structure and semanticsfor the exchange of productinformation. [HL7]
|-
| CDISCglossary||human role||study coordinator. See clinical research coordinator
|-
| CDISCglossary||study||study description. Representationof key elements of study; e.g., control,blinding, gender, dose, indication,configuration.
|-
| CDISCglossary||study||study design rationale. Reason for choosing the particular study design.
|-
| CDISCglossary||study||study design schematic.Diagrammatic representation of keyactivities within the study.
|-
| CDISCglossary||study||study design. Plan for the preciseprocedure to be followed in a clinicaltrial, including planned and actualtiming of events, choice of controlgroup, method of allocatingtreatments, blinding methods; assignsa subject to pass through one or more epochs in the course of the trial
|-
| CDISCglossary||date||study initiation. Date and time ofinformed consent of first subjectenrolled into a study. [ICH E3] Compareto study start. Synonym: date of firstenrollment.
|-
| CDISCglossary||population||study population. Defined byprotocol inclusion/exclusion criteria.study protocol. See protocol.
|-
| CDISCglossary||protocol||study protocol. See protocol.
|-
| CDISCglossary||event||study start. The formal recognition ofthe beginning of a clinical trial that isreferred to in the clinical study report.
|-
| CDISCglossary||role||study variable. A term used in trialdesign to denote a variable to becaptured on the CRF. See also variable.
|-
| CDISCglossary||study||study. See clinical trial. NOTE:Occasionally refers to a project of several related clinical trials.
|-
| CDISCglossary||human role||sub-investigator. Any member ofthe clinical trial team designated andsupervised by the investigator at a trialsite to perform critical trial-relatedprocedures and/or to make importanttrial-related decisions (e.g., associates,residents, research fellows) [ICH] See associates, residents, research fellows
|-
| CDISCglossary||event||subject data event. A subject visitor other encounter where subject dataare collected, generated or reviewed.
|-
| CDISCglossary||identifier||subject identification code. Aunique identifier assigned by theinvestigator to each trial subject toprotect the subject’s identity and usedin lieu of the subject’s name when theinvestigator reports adverse eventsand/or other trial-related data.
|-
| CDISCglossary||human role||subject/trial subject. An individualwho participates in a clinical trial,either as recipient of the investigationalproduct(s) or as a control. [ICH] Seealso healthy volunteer, human subject.
|-
| CDISCglossary||data||subject-reported outcome (SRO).
|-
| CDISCglossary||evidence code||subject-reported outcome (SRO).An outcome reported directly by asubject in a clinical trial. [Patrick, D.L.,2003] See also patient-reportedoutcome (PRO).
|-
| CDISCglossary||data format||submission model. A set of datastandards (including SDTM, ADaM anddefine.xml) for representing data thatare submitted to regulatory authoritiesto support product marketingapplications. NOTE: CDISC submissiondata consist of: tabulations thatrepresent the essential data collectedabout patients; analysis data structuredto support analysis and interpretation;and metadata descriptions.
|-
| CDISCglossary||study||superiority trial. A trial with theprimary objective of showing that theresponse to the investigational productis superior to a comparative agent(active or placebo control). [ICH E9]supplier. An organization that entersinto a contract with the acquirer for
|-
| CDISCglossary||organization role||supplier. An organization that entersinto a contract with the acquirer for the supply of a system, softwareproduct, or software service under theterms of a contract.
|-
| CDISCglossary||role||supporting variables. See variable
|-
| CDISCglossary||role||surrogate marker. A measurementof a drug’s biological activity thatsubstitutes for a clinical endpoint suchas death or pain relief.
|-
| CDISCglossary||role||surrogate variable. A variable thatprovides an indirect measurement ofeffect in situations where directmeasurement of clinical effect is notfeasible or practical.
|-
| CDISCglossary||protocol||survey. Any means (e.g.,questionnaire, diary, interview script,group of items) that is used to collectPRO data. NOTE: Survey refers to thecontent of the group of items and doesnot necessarily include the training andscoring documents generally not seen by respondants
|-
| CDISCglossary||other||syntactic. The order, format, contentof clinical trial data and/or documentsas distinct from their meaning NOTE:Syntactic interoperability is achievedwhen information is correctlyexchanged between two systemsaccording to structured rules whether or not sensible meaning is preserved
|-
| CDISCglossary||aggregate||system. People, machines, software, applications and/or methods organized to accomplish a set of specific functions or objectives.
|-
| CDISCglossary||protocol||target enrollment. The number ofsubjects in a class or group (includingthe total for the entire trial) intendedto be enrolled in a trial to reach theplanned sample size. Targetenrollments are set so that statisticaland scientific objectives of a trial will be met
|-
| CDISCglossary||role||technology provider. A person,company or other entity who develops,produces and sells softwareapplications and/or hardware for use inconducting clinical trials and/or inanalyzing clinical trial data and orsubmitting clinical trial information for regulatory approval
|-
| CDISCglossary||event||termination (of subject). Nowconsidered nonstandard. Seediscontinuation.
|-
| CDISCglossary||event||termination (of trial). Prematurediscontinutation of a trial prior to plan.
|-
| CDISCglossary||standard||terminology. A standardized, finiteset of terms (e.g., picklists, ICD9 codes)that denote patient findings,circumstances, events, andinterventions. NOTE: The terms shouldhave sufficient detail to support clinicalresearch, healthcare decisions,outcomes research and qualityimprovement. Standardization shouldbe sufficient that the same set of termsmay be extended to administrative,regulatory, and fiscal applications. [J.J.Cimino] Compare to glossary, which isa list of words and their definitionspertaining to usage in a particular fieldor context.
|-
| CDISCglossary||protocol||therapeutic intervention. Seeintervention
|-
| CDISCglossary||protocol||Time-of-entry editchecks are a type of edit check that isrun (executed) at the time data arefirst captured or transcribed to an
|-
| CDISCglossary||document||Tome. Record documenting everycomment on proposed regulations thathas been addressed by FDA
|-
| CDISCglossary||protocol||transcription. Process oftransforming dictated or otherwisedocumented information from onestorage medium to another. NOTE:often refers explicitly to data that ismanually transcribed from source docsor measuring devices to CRFs or to eCRFs
|-
| CDISCglossary||event||treatment effect. An effectattributed to a treatment in a clinicaltrial. In most clinical trials thetreatment effect of interest is acomparison (or contrast) of two ormore treatments.
|-
| CDISCglossary||event||treatment-emergent adverseevent. An event that emerges duringtreatment, having been absentpretreatment, or worsens relative tothe pretreatment state.
|-
| CDISCglossary||role||trial coordinator. See clinicalresearch coordinator.
|-
| CDISCglossary||standard||Trial Design Model. Defines astandard structure for representing theplanned sequence of events and thetreatment plan of a trial. NOTE: acomponent of the SDTM that buildsupon elements, arms epochs, visits;suitable also for syntactic interpretationupon elements, arms epochs, visits;suitable also for syntactic interpretationby machines. [CDISC] See study design.
|-
| CDISCglossary||role||trial site. The location(s) where trialrelatedactivities are actuallyconducted.
|-
| CDISCglossary||human role||trial statistician. A statistician whohas a combination ofeducation/training and experiencesufficient to implement the principles inthe ICH E9 guidance and who isresponsible for the statistical aspects ofthe trial. [ICH E9]
|-
| CDISCglossary||role||trial subject. Subject in a clinicaltrial. See also participant, patient,subject
|-
| CDISCglossary||study design||triple-blind study. A study in whichknowledge of the treatmentassignment(s) is concealed from thepeople who organize and analyze thedata of a study as well as from subjectsand investigators.
|-
| CDISCglossary||statistics||t-test. A statistical test used tocompare the means of two groups oftest data
|-
| CDISCglossary||statistics||type 1 (or type I) error. Error madewhen a null hypothesis is rejected butis actually true. Synonym: false positive.type 2 (or type II) error. Errormade when an alternative hypothesis isrejected when it is actually true.Synonym: false negative.
|-
| CDISCglossary||statistics||type 2 (or type II) error. Errormade when an alternative hypothesis isrejected when it is actually true.Synonym: false negative.
|-
| CDISCglossary||statistics||type 3 (or type III) error. Somestatisticians use this designation for anerror made when calling the lesseffective treatment the more effectiveone.
|-
| CDISCglossary||protocol||type of comparison. Howtreatment arms will be compared, e.g.,Safety, Efficacy, PK/PD. May alsoinclude comparison to data from otherstudies or sources; e.g., historicalcontrol.
|-
| CDISCglossary||protocol||unblinding. Identification of thetreatment code of a subject or groupedresults in studies where the treatmentassignment is unknown to the subjectand investigators
|-
| CDISCglossary||statistics||unequal randomization. Seerandomization.
|-
| CDISCglossary||unscheduled||unexpected adverse drugreaction. An adverse reaction, whosenature, severity, specificity, or outcomeis not consistent with the term ordescription used in the applicableproduct information. See alsoadverse drug reaction.
|-
| CDISCglossary||computer||uniform resource locator (URL).Address of a Web page,actmagazine.com, for example
|-
| CDISCglossary||protocol||user site testing (UST). Any testingthat takes place outside of thedeveloper’s controlled environment.NOTE: Terms such as beta test, sitevalidation, user acceptance test,installation verification, and installationtesting have all been used to describe UST
|-
| CDISCglossary||characteristic; evidence code||valid. 1. Sound. 2. Well grounded on principles of evidence. 3. Able to withstand criticism or objection
|-
| CDISCglossary||protocol||validation of data. 1. A processused to determine if data areinaccurate, incomplete, orunreasonable. The process may includeformat checks, completeness checks,check key tests, reasonableness checksand limit checks. 2. The checking ofdata for correctness or compliance withapplicable standards, rules, andconventions. NOTE: Meaning 1. is not“data verification” but meaning 2.could be
|-
| CDISCglossary||protocol||validation. 1. Process ofestablishing suitability to purpose. 2.For software and systems, establishingdocumented evidence which providesa high degree of assurance that aspecific process will consistentlyproduce a product meeting itspredetermined specifications andquality attributes. NOTE: Validation isaccomplished by planning how tomeasure and/or evaluate suitability topurpose; then executing the plan anddocumenting the results. [FDA
|-
| CDISCglossary||protocol||validity, psychometric. Seepsychometric validation.
|-
| CDISCglossary||protocol||validity. See validation.
|-
| CDISCglossary||role||variable. 1. Any quantity that varies;any attribute, phenomenon or eventthat can have different qualitative orquantitative values. 2. In SDTM“variables” are used to describeobservations. Such describingvariables have roles that determine the type of information conveyed by the variable about each observation and how it can be used
|-
| CDISCglossary||statistics||variance. A measure of the
|-
| CDISCglossary||computer||verification Provides objective evidence that the design outputs of a particular phaseof the software development life cycle meet all of the specified requirements
|-
| CDISCglossary||protocol||verification. 1. The act of reviewing, inspecting, testing,checking, auditing, or otherwise establishing and documenting confirmation to requirements see source doc verification (SDV)
|-
| CDISCglossary||protocol||verification. Verification usuallyconcerns confirmation that specifiedrequirements have been met, buttypically refers to the tracing ofrequirements and evidence ofconformance in the individual phasesor modules rather than suitability ofthe complete product. Validation is,“the evaluation of software at the endof the software development processto ensure compliance with the userrequirements” (ANSI/ASQC A3-1978)and should not be thought of as an end to end process
|-
| CDISCglossary||protocol||visit. A clinical encounter thatencompasses planned and unplannedtrial interventions, procedures andassessments that may be performed
|-
| CDISCglossary||role||volunteer. A person volunteering toparticipate as a subject in a clinicaltrial, often a healthy person agreeingto participate in a Phase 1 trial. See
|-
| CDISCglossary||role||vulnerable subjects. Individualswhose willingness to volunteer in aclinical trial may be unduly influencedby the expectation, whether justified
|-
| CDISCglossary||ducument||Warning Letter. A written
|-
| CDISCglossary||protocol||washout period. A period in a
|-
| CDISCglossary||computer||Web browser. A computer program
|-
| CDISCglossary||computer||Web page. A single page on a Web
|-
| CDISCglossary||computer||Web server. A computer server that
|-
| CDISCglossary||computer||Web site. A collection of Web pages
|-
| CDISCglossary||stats||weighting. An adjustment in a value
|-
| CDISCglossary||characteristic||well-being (of the trial subjects). The physical and mental integrity of the subjects participating
|-
| CDISCglossary||protocol||withdrawal. The act of reducing thedegree of participation by a subject in
|-
| CDISCglossary||other||within-subject differences. In acrossover trial, variability in eachsubject is used to assess treatmentdifferences.
|-
| CDISCglossary||computer||World Wide Web. All the resources
|-
| FCR||||1. Basic vs applied
|-
| FCR||||1. Hierarchical – show vertical relationships
|-
| FCR||quality||1. Morbidity
|-
| FCR||data||1. Outcome assessment
|-
| FCR||||1. Physical
|-
| FCR||protocol||1. Tradition (precedent)
|-
| FCR||study design||10. Historical research
|-
| FCR||quality||10. self-assessment of functional capacity
|-
| FCR||role||10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
|-
| FCR||||11. Propositions – state the relationships between variables
|-
| FCR||quality||11. quality of life
|-
| FCR||study design||11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
|-
| FCR||data model||12. Model – symbolic representation of the elements of a system
|-
| FCR||study design||12. Single-subject design
|-
| FCR||conclusion||13. Inductive theory – theory based on empirically verifiable observations
|-
| FCR||study design||13. Sequential clinical trial
|-
| FCR||study design||14. Evaluation research – assessment of the success of a program or policy
|-
| FCR||conclusion||14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
|-
| FCR||conclusion||15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
|-
| FCR||study design||15. Quasi-experimental research
|-
| FCR||protocol||16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
|-
| FCR||study design||16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
|-
| FCR||protocol||17. Deduction – theory testing
|-
| FCR||study design||17. Qualitative vs quantitative research
|-
| FCR||protocol||18. Induction – theory development
|-
| FCR||data||2. Acute conditions and chronic conditions
|-
| FCR||protocol||2. Authority (trusted expert)
|-
| FCR||quality||2. mortality
|-
| FCR||study design||2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
|-
| FCR||||2. Schematic
|-
| FCR||time||2. Temporal – order concepts in time and states a sequence of events
|-
| FCR||study design||3. Case study – description of one or more patients
|-
| FCR||data||3. length of stay
|-
| FCR||||3. Process
|-
| FCR||time||3. Quantitative – frequency or duration of a specific behavior
|-
| FCR||data||3. Sources of knowledge
|-
| FCR||protocol||3. Trial and error
|-
| FCR||study design||4. Developmental research – description of pattern of change over time
|-
| FCR||protocol||4. Logical reasoning - Deductive reasoning, Inductive reasoning
|-
| FCR||data||4. readmission
|-
| FCR||||4. Statistical
|-
| FCR||science||4. Types of research
|-
| FCR||study design||5. Normative research – establishing normal values
|-
| FCR||quality||5. Physical
|-
| FCR||protocol||5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
|-
| FCR||study design||6. Qualitative research – gathering data through interview or observation
|-
| FCR||quality||6. social
|-
| FCR||data model||6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
|-
| FCR||study design||7. Cohort or case-control studies – establish associations
|-
| FCR||hypothesis||7. Hypothesis - specific predictions based on a theory.
|-
| FCR||quality||7. psychological well-being
|-
| FCR||data||8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
|-
| FCR||study design||8. Methodological studies – establish reliability and validity of a new method
|-
| FCR||quality||8. Patient satisfaction
|-
| FCR||data||9. Constructs – concepts that represent non-observable behaviors or events
|-
| FCR||quality||9. patient preference
|-
| FCR||study design||9. Secondary analysis – exploring new relationships in old data
|-
| MUSC||data||accrual rate
|-
| MUSC||role||active control
|-
| MUSC||||adherence
|-
| MUSC||unscheduled||adjustment
|-
| MUSC||unscheduled||adverse event
|-
| MUSC||data||allocation ratio
|-
| MUSC||statistics||alternative hypothesis
|-
| MUSC||data||analysis datasets
|-
| MUSC||protocol||assessment
|-
| MUSC||statistics||assessment bias
|-
| MUSC||time||assessment schedule
|-
| MUSC||||as-treated
|-
| MUSC||protocol||auditing
|-
| MUSC||study design||balanced design
|-
| MUSC||||baseline
|-
| MUSC||||baseline comparability
|-
| MUSC||statistics||bias
|-
| MUSC||protocol||biased coin randomizaiton
|-
| MUSC||statistics||binormial
|-
| MUSC||quality||bioequivalence
|-
| MUSC||protocol||blinding
|-
| MUSC||role||block
|-
| MUSC||data||carryover effect
|-
| MUSC||document||case report
|-
| MUSC||document||case report form
|-
| MUSC||study design||case-control design
|-
| MUSC||protocol||censoring
|-
| MUSC||data||clinical trial management system
|-
| MUSC||protocol||cluster randomization
|-
| MUSC||protocol||coding
|-
| MUSC||role||cohort
|-
| MUSC||study design||community intervention trial
|-
| MUSC||quality||comparative treatment efficacy
|-
| MUSC||quality||complaince
|-
| MUSC||role||concurrent controls
|-
| MUSC||statistics||confidence interval
|-
| MUSC||study design||confirmatory trial
|-
| MUSC||role||confounder
|-
| MUSC||role||confounding factor
|-
| MUSC||document||CONSORT statement
|-
| MUSC||||constrain
|-
| MUSC||||context
|-
| MUSC||data||continous
|-
| MUSC||role||controls
|-
| MUSC||study design||crossover
|-
| MUSC||study design||crossover trial
|-
| MUSC||||cross-sectional analysis
|-
| MUSC||organization role||data and safety monitoring board
|-
| MUSC||document||data clarification query
|-
| MUSC||document||data clarification request
|-
| MUSC||time||data collection schedule
|-
| MUSC||protocol||data management
|-
| MUSC||protocol||data management plan
|-
| MUSC||organization role||data safety monitoring committee
|-
| MUSC||data||database
|-
| MUSC||protocol||data-dependent stopping
|-
| MUSC||data||derived data
|-
| MUSC||||deterministic
|-
| MUSC||study design||diagnostic trial
|-
| MUSC||||dichotomous
|-
| MUSC||data||discret
|-
| MUSC||conclusion||dose finding
|-
| MUSC||protocol||double blinding
|-
| MUSC||protocol||double masking
|-
| MUSC||unscheduled||dropouts
|-
| MUSC||quality||drug lot
|-
| MUSC||unscheduled||early termination
|-
| MUSC||quality||efficacy
|-
| MUSC||protocol||electronic data capture
|-
| MUSC||protocol||eligibility
|-
| MUSC||data||endpoint
|-
| MUSC||quality||equipoise
|-
| MUSC||study design||equivalence trials
|-
| MUSC||protocol||estimate
|-
| MUSC||protocol||evaluation
|-
| MUSC||organization role||excecutive committee
|-
| MUSC||protocol||exclusion criteria
|-
| MUSC||||expectation bias
|-
| MUSC||||experiment
|-
| MUSC||study design||factorial design
|-
| MUSC||protocol||follow-up
|-
| MUSC||||group sequential
|-
| MUSC||role||historic controls
|-
| MUSC||statistics||imbalance
|-
| MUSC||protocol||imputation of missing data
|-
| MUSC||protocol||inclusion criteria
|-
| MUSC||protocol||informed consent
|-
| MUSC||organization role||institutional review board
|-
| MUSC||protocol||intention to treat
|-
| MUSC||role||intention to treat population
|-
| MUSC||statistics||interaction
|-
| MUSC||protocol||interim analysis
|-
| MUSC||||intersubject
|-
| MUSC||role||intervention
|-
| MUSC||||intrasubject
|-
| MUSC||document||investigational new drug (IND) application
|-
| MUSC||quality||investigator competence
|-
| MUSC||||local control
|-
| MUSC||data||lost to follow-up
|-
| MUSC||statistics||main effect
|-
| MUSC||protocol||masking
|-
| MUSC||person role||medical safety monitor
|-
| MUSC||protocol||meta-analysis
|-
| MUSC||protocol||minimization randomization
|-
| MUSC||||minority representation
|-
| MUSC||data||missing data
|-
| MUSC||protocol||monitoring
|-
| MUSC||study design||multi-center
|-
| MUSC||study design||multi-site
|-
| MUSC||statistics||multivariable
|-
| MUSC||conclusion||negative findings
|-
| MUSC||statistics||nesting design
|-
| MUSC||document||new drug application (NDA)
|-
| MUSC||statistics||Neyman allocation
|-
| MUSC||unscheduled||nonadherence
|-
| MUSC||unscheduled||noncomplaince
|-
| MUSC||||noninferiority
|-
| MUSC||statistics||null hypothesis
|-
| MUSC||data||observation
|-
| MUSC||statistics||odds
|-
| MUSC||statistics||odds ratio
|-
| MUSC||statistics||one-sided test
|-
| MUSC||||optimal allocation
|-
| MUSC||quality||over-the -count (OTC)
|-
| MUSC||study design||parallel design
|-
| MUSC||protocol||permuted block randomization
|-
| MUSC||role||per-protocol population
|-
| MUSC||study design||phase I trial
|-
| MUSC||study design||phase II trial
|-
| MUSC||study design||phase IIA
|-
| MUSC||study design||phase IIB
|-
| MUSC||study design||phase IIB
|-
| MUSC||study design||phase III trial
|-
| MUSC||study design||phase IV trial
|-
| MUSC||study design||pivotal trials
|-
| MUSC||study design||placebo controlled
|-
| MUSC||protocol||play the winner
|-
| MUSC||role||plecabo
|-
| MUSC||aggregate||population
|-
| MUSC||conclusion||positive findings
|-
| MUSC||statistics||power
|-
| MUSC||study design||prevention trials
|-
| MUSC||||primary efficacy
|-
| MUSC||conclusion||primary outcome
|-
| MUSC||data||primary response
|-
| MUSC||person role||principal investigator
|-
| MUSC||role||prognostic factor
|-
| MUSC||protocol||project management
|-
| MUSC||protocol||project management plan
|-
| MUSC||protocol||protocal complaince
|-
| MUSC||protocol||protocol
|-
| MUSC||unscheduled||protocol exception
|-
| MUSC||unscheduled||protocol violation
|-
| MUSC||statistics||pseudorandom
|-
| MUSC||statistics||p-value
|-
| MUSC||protocol||quality assurance
|-
| MUSC||protocol||random play the winner
|-
| MUSC||protocol||recruitment
|-
| MUSC||protocol||regulatory management
|-
| MUSC||data||repeat measurement
|-
| MUSC||data||response
|-
| MUSC||protocol||response adaptive randomization
|-
| MUSC||study design||retrospective design
|-
| MUSC||quality||safety
|-
| MUSC||statistics||sample size
|-
| MUSC||||sample size inflation
|-
| MUSC||protocol||screening
|-
| MUSC||||selection bias
|-
| MUSC||study design||sequential design
|-
| MUSC||unscheduled||serious adverse event
|-
| MUSC||role||sham treatment
|-
| MUSC||study design||single-center
|-
| MUSC||study design||single-site
|-
| MUSC||document||source document
|-
| MUSC||person role||sponsor
|-
| MUSC||protocol||statistical analysis plan
|-
| MUSC||statistics||statistical significant
|-
| MUSC||organization role||steering committee
|-
| MUSC||protocol||stop rule
|-
| MUSC||statistics||stratification
|-
| MUSC||person role||study coordinator
|-
| MUSC||role||subject
|-
| MUSC||quality||superiority
|-
| MUSC||conclusion||surrogate outcome
|-
| MUSC||time||time to event
|-
| MUSC||protocol||titration
|-
| MUSC||quality||tocxicity
|-
| MUSC||quality||tolerability
|-
| MUSC||role||treatment
|-
| MUSC||||treatment allocation
|-
| MUSC||role||treatment group
|-
| MUSC||unscheduled||treatment-emergenet adverse event (TEAE)
|-
| MUSC||protocol||trilple blinding
|-
| MUSC||protocol||triple masking
|-
| MUSC||statistics||two-sided test
|-
| MUSC||statistics||type I error
|-
| MUSC||statistics||type II error
|-
| MUSC||statistics||univariable
|-
| MUSC||protocol||urn randomization
|-
| MUSC||||varibility
|-
| MUSC||time||washout period
|-
| MUSC||protocol||withdrawal consent
|-
| RCT||role||Analyzed population
|-
| RCT||time||Anchored-time
|-
| RCT||conclusion||Ancillary-outcome
|-
| RCT||data||Baseline
|-
| RCT||protocol||Blinding
|-
| RCT||protocol||Blinding-method
|-
| RCT||study design||Cointervention*
|-
| RCT||study design||Comparison-arm
|-
| RCT||quality||Cost
|-
| RCT||role||Crossover population
|-
| RCT||time||Date
|-
| RCT||||Device
|-
| RCT||time||Double-anchored-interval
|-
| RCT||role||Drug
|-
| RCT||protocol||Drug-step
|-
| RCT||time||Duration
|-
| RCT||role||Eligible-population
|-
| RCT||role||Enrolled-population
|-
| RCT||role||Excluded population
|-
| RCT||protocol||Exclusion-rule
|-
| RCT||protocol||Executed-protocol
|-
| RCT||protocol||Executed-secondary-study-protocol
|-
| RCT||study design||Experimental-arm
|-
| RCT||protocol||Follow-up activity
|-
| RCT||role||Funder
|-
| RCT||protocol||Inclusion-rule
|-
| RCT||organization||Institution
|-
| RCT||protocol||Intended-protocol
|-
| RCT||protocol||Intended-secondary-study-protocol
|-
| RCT||time||Interval
|-
| RCT||study design||Intervention*
|-
| RCT||study design||Intervention-arm
|-
| RCT||protocol||Intervention-step
|-
| RCT||role||Investigator
|-
| RCT||protocol||Non-drug-intervention-step
|-
| RCT||||No-treatment
|-
| RCT||data||Outcome
|-
| RCT||data||Outcomes-followup
|-
| RCT||role||Placebo
|-
| RCT||conclusion||Primary-outcome
|-
| RCT||protocol||Primary-recruitment-flowchart
|-
| RCT||protocol||Procedure
|-
| RCT||protocol||Protocol
|-
| RCT||unscheduled||Protocol-change
|-
| RCT||protocol||Protocol-concept
|-
| RCT||role||Randomized-population
|-
| RCT||||Reason
|-
| RCT||role||Recruited-population
|-
| RCT||protocol||Recruitment-flowchart
|-
| RCT||role||Screened-population
|-
| RCT||conclusion||Secondary-outcome
|-
| RCT||study design||Secondary-study
|-
| RCT||protocol||Secondary-study-protocol
|-
| RCT||data||Side-effect
|-
| RCT||time||Single-anchored-interval
|-
| RCT||role||Site-enrollment
|-
| RCT||protocol||Stopping-rule
|-
| RCT||role||Study-arm population
|-
| RCT||organization role||Study-committee
|-
| RCT||conclusion||Study-outcome
|-
| RCT||organization role||Study-site
|-
| RCT||time||Timepoint
|-
| RCT||time||Time-range
|-
| RCT||role||Treatment-assignment
|-
| RCT||||Trial
|-
| RCT||role||Trial-participant
|-
| RCT||data||Withdrawal-reason
|-
|
|}

High-level Concepts v0.2

2007-05-09T19:51:16Z

Jalee:

Go back to [[CTO:Main Page]]

==High-Level Concepts version 0.2==
Initial High-level Concepts in black font

Additions from Simona in blue font

Additions from Richard in green font
*Events
*Periods
**Study phases
**Protocol phases
*Sequence of events
*Study designs
**Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics
***Case study – description of one or more patients
***Developmental research – description of pattern of change over time
***Normative research – establishing normal values
***Qualitative research – gathering data through interview or observation
***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires
**Exploratory research
***Cohort or case-control studies – establish associations through epidemiological studies
***Methodological studies – establish reliability and validity of a new method
***Secondary analysis – exploring new relationships in old data
***Historical research – reconstructing the past through an assessment of archives or other records
**Experimental research
***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
****Single-subject design
****Sequential clinical trial
****Evaluation research – assessment of the success of a program or policy
***Quasi-experimental research
***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis

*Research types
**Randomized Clinical Trial
*Methods
*Stakeholders
**Participants
**Investigators
**Monitors
***Study committee
**Sponsors
*Populations
**Recruited population
***Randomized population
***Enrolled population
***Eligible population
***Screened population

**Excluded population
***Excluded postrandomization population
***Not-randomized-population
***Not-enrolled-population
***Not-eligible-population

**Analyzed-population
***All subjects
***Study arm population
***Crossover population
***Subgroup population

*Variables
**Independent variable
***Intervention
****Procedure
****Device implantation
****Drug treatment
****Placebo treatment
****Sham procedure
****Usual care
****Counseling
***Cointervention

**Dependent variable (responding variable)
***Outcome
****Primary outcome
****Secondary outcome
****Adverse event/Side effect
****Ancillary outcome

*Digital and paper artifacts
*Protocol
**Intended protocol
**Executed protocol
**Protocol change

*Protocol application
**Assessments
***Experimental assays
***Observations
****Physical exam
***Interview
***Self-assessments
**Data analysis
***Data partitioning
***Data transformation
***Data pooling
***Data summarization
***Reliability
***Correlation
**Specimen processing
***Procurement
***Specimen partitioning/purification
***Specimen storage
**Treatment assignment
**Blinding
**Follow-up

*Measurement scale
**Nominal
**Ordinal
**Interval
**Ratio
*Participant characteristic (phenotype)
**Baseline characteristic

OBI v0.6.6 Schematic

2007-05-09T19:50:29Z

Jalee:

Go back to [[CTO:Main Page]]

Click on image below to download. BFO terms are shaded in light yellow; OBI terms are shaded in darker yellow.

[[Image:OBI v0.6.6.png]]

OBI v0.6.6 Schematic

2007-05-09T19:49:21Z

Jalee: New page: Click on image below to download. BFO terms are shaded in light yellow; OBI terms are shaded in darker yellow. Image:OBI v0.6.6.png

Click on image below to download. BFO terms are shaded in light yellow; OBI terms are shaded in darker yellow.

[[Image:OBI v0.6.6.png]]

OCI:Main Page

2007-05-09T19:47:55Z

Jalee: /* Ontology Development Items */

=CTO - Clinical Trials Ontology=

==About CTO==

The goal of the CTO Working Group is to foster the creation and dissemination of a reference ontology (high-quality controlled structured vocabulary) for the annotation of the results of clinical trials.

==Recent Developments==

==Conference Call Information==
* [[Conference Call Schedule]]
* [[Call-in Information]]
* [[Conference Call Agendas]]
* [[Conference Call Minutes]]
* [[Action Items]]

==Meetings==
* [[Upcoming Meetings]]
* [[Meetings Attended]]

==Communities and Working Group (WG) Participants==
* [[CTO WG Chairs]]
* [[CTO Curators]]
* [[Other members of CTO WG]]

==Draft version of CTO==

==Ontology Development Items==
* [[Design Principles]]
* [[Term Lists]]
* [[High-level Concepts]]
* [[High-level Concepts v0.2]]
* [[Initial CTO-OBI Mapping]]
* [[CTO Term Compilation (Jennifer)]]
* [[OBI v0.6.6 Schematic]]

==CTO Development Policies==
* [[Ontology Metadata Policy (from OBI)]]
* [[CTO Check-out Procedure Policy]]
* [[CTO Working Group Membership Policy]]

==Publications==

CTO Google group: http://groups.google.com/group/CTOtlg

CTO Google mailing list: mailto:CTOtlg@googlegroups.com

CTO SVN repository: http://cto.googlecode.com/svn/trunk/CTO.owl (save as CTO.owl)

==CTO Wiki information==

High-level Concepts

2007-05-09T19:47:00Z

Jalee:

Go back to [[CTO:Main Page]]

==High-Level Concepts==
*Events
*Periods
**Study phases
**Protocol phases
*Sequence of events
*Study designs
*Research types
*Methods
*Stakeholders
**Participants
**Investigators
**Monitors
**Sponsors
*Populations
*Variables
**Independent variable
**Dependent variable (responding variable)
***Outcome
*Digital and paper artifacts
*Protocol
*Protocol application
**Assessments
***Experimental assays
***Observations
****Physical exam
***Interview
***Self-assessments
**Data analysis
***Data partitioning
***Data transformation
***Data pooling
***Data summarization
***Reliability
***Correlation
**Specimen processing
***Procurement
***Specimen partitioning/purification
***Specimen storage
*Measurement scale
**Nominal
**Ordinal
**Interval
**Ratio
*Participant characteristic (phenotype)

File:OBI v0.6.6.jpg

2007-05-07T15:56:41Z

Jalee:

High-level Concepts

2007-05-07T15:37:42Z

Jalee: /* OBI v0.6.6 Schematic */

High-level Concepts

2007-05-07T15:35:07Z

Jalee: /* High-Level Structure from BFO-OBI */

File:OBI v0.6.6.png

2007-05-07T15:33:29Z

Jalee:

High-level Concepts

2007-05-04T20:53:49Z

Jalee: /* High-Level Structure from BFO-OBI */

Minutes from 05/03/07 Conference Call

2007-05-03T18:33:00Z

Jalee:

Go back to [[CTO:Main Page]]

* Jennifer gives high-level overview of OBI and goes over term list and a first pass at categorizing terms within OBI branches

* There is some confusion over how to keep track of the most current OBI version

* All agreed that OBI schematic is a useful visual aid for evaluating how CTO would fit in the OBI framework, but needs to be accurately synchronized with current OBI draft

* Modeling of plans (the process, implementation, and representation) needs to be worked out and clearly defined

* How do we represent derived data? Define the input, protocol application, and output and then link together using the Relation Ontology

* Touched on how to organize a week-long developers workshop without funding sources (or how to find funding). Will bring this up at the CTO workshop.

Minutes from 05/03/07 Conference Call

2007-05-03T18:30:19Z

Jalee: New page: * Jennifer gives high-level overview of OBI and goes over term list and a first pass at categorizing terms within OBI branches * There is some confusion over how to keep track of the most...

* Jennifer gives high-level overview of OBI and goes over term list and a first pass at categorizing terms within OBI branches

* There is some confusion over how to keep track of the most current OBI version

* All agreed that OBI schematic is a useful visual aid for evaluating how CTO would fit in the OBI framework, but needs to be accurately synchronized with current OBI draft

* Modeling of plans (the process, implementation, and representation) needs to be worked out and clearly defined

* How do we represent derived data? Define the input, protocol application, and output and then link together using the Relation Ontology

* Touched on how to organize a week-long developers workshop without funding sources (or how to find funding). Will bring this up at the CTO workshop.

Conference Call Minutes

2007-05-03T18:27:19Z

Jalee:

Go back to [[CTO:Main Page]]

* [[Minutes from 05/03/07 Conference Call]]
* [[Minutes from 04/19/07 Conference Call]]
* [[Minutes from 04/12/07 Conference Call]]

Action items from 05/03/07 call

2007-05-03T17:10:12Z

Jalee:

Go back to [[CTO:Main Page]]

*Review term lists and Jennifer’s shot at placing terms into OBI categories (download the May 3 excel file to manipulate the term lists and add your comments).

*Re-generate OBI schematic based on current OBI version and come up with a permanent way to accurately synchronize the schematic with the current OBI draft.

*Richard will send out email about upcoming workshop, including issues that need to be addressed (such as how we want others to contribute to CTO developoment in a controlled fashion), what we should present, and what we want to accomplish (especially on Day 2.

Action items from 05/03/07 call

2007-05-03T17:09:29Z

Jalee: New page: *Review term lists and Jennifer’s shot at placing terms into OBI categories (download the May 3 excel file to manipulate the term lists and add your comments). *Re-generate OBI schemat...

*Review term lists and Jennifer’s shot at placing terms into OBI categories (download the May 3 excel file to manipulate the term lists and add your comments).

*Re-generate OBI schematic based on current OBI version and come up with a permanent way to accurately synchronize the schematic with the current OBI draft.

*Richard will send out email about upcoming workshop, including issues that need to be addressed (such as how we want others to contribute to CTO developoment in a controlled fashion), what we should present, and what we want to accomplish (especially on Day 2.

Action Items

2007-05-03T17:08:05Z

Jalee:

Go back to [[CTO:Main Page]]

*[[Action items from 05/03/07 call]]
*[[Action items from 04/19/07 call]]

Conference Call Agendas

2007-05-03T14:54:27Z

Jalee:

Go back to [[CTO:Main Page]]

= Conference Call Agendas =

==May 3==
*Discussion of High-Level BFO-OBI Structure
*Discussion of new added terms
*Plans for CTO Workshop
*Action items for the coming week

==April 19==
'''1. Ontology of Biomedical Investigation'''
*a. Overview of OBI core (Fostel, tentative)
'''2. CTO development approach (with deadlines and milestones)'''
*a. Goals for completion by May16th
*b. Status of proposed steps
**term list assembly
**term list merging
**term positioning into branches
**term CTO definition
'''3. High-level concept branches'''

'''4. Others'''

==April 12==
'''1. CTO Working Group (WG) Organization'''
*a. Are current assignments acceptable?
*b. Need a secretary
*c. Responsibilities
*d. Schedule of calls
'''2. Development and WG policies in general'''
*a. Draft metadata and CTO check-out policies
*b. CTO WG membership policy
'''3. Ontology Organization'''
*a. Relationship with the BFO
*b. Relationship with the OBI
'''4. CTO scope'''
*a. Definition of the CTO domain
*b. Relationship with other ontologies
'''5. CTO development approach (with deadlines and milestones)'''
*a. Proposed steps
**term list assembly
**term list merging
**term positioning into branches
**term CTO definition
*b. Goals for completion by May 16th
*c. Managing discussion threads
'''6. Information objects as dependent continuants (if time)'''

OCI Term Compilation (Jennifer)

2007-05-03T14:44:58Z

Jalee:

Go back to [[CTO:Main Page]]

Download the term list here:
[[Image:CTO-may3.xls]]

Or view the list here:

{| {{table}}
| align="center" style="background:#f0f0f0;"|'''source'''
| align="center" style="background:#f0f0f0;"|'''draft category'''
| align="center" style="background:#f0f0f0;"|'''term / definition'''
|-
| CDISCglossary||unscheduled||adverse event (AE). Synonyms: side effect, adverse experience.
|-
| CDISCglossary||role||analysis variables.
|-
| CDISCglossary||document||approval letter. An official communication from FDA;allow marketing
|-
| CDISCglossary||time||arm. A planned sequence of elements, typically equivalent to a treatment group. [SDTM]
|-
| CDISCglossary||protocol||audit
|-
| CDISCglossary||protocol||baseline assessment
|-
| CDISCglossary||document||Biologics Licensing Application (BLA). An application to FDA for a license to market
|-
| CDISCglossary||study design||blinded study. A study in which is unaware of the treatment assignment
|-
| CDISCglossary||data||causality assessment. An evaluation performed by a medical professional
|-
| CDISCglossary||quality||clinical benefit.
|-
| CDISCglossary||data||clinical clarification. A query resolution from the sponsor See also self evident change.
|-
| CDISCglossary||quality||clinical efficacy.
|-
| CDISCglossary||quality||clinical significance. Change in a subject’s clinical condition regarded as important whether or not due to the test intervention. criteria for clinical significance should be stated in the protocol.
|-
| CDISCglossary||data||clinical trial information. Data collected in the course of a clinical trial
|-
| CDISCglossary||document||Common Technical Document. A format agreed upon by ICH See also eCTD.
|-
| CDISCglossary||data||confidentiality. Prevention of
|-
| CDISCglossary||study design||confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
|-
| CDISCglossary||person role||consumer safety officer (CSO). FDA official who coordinates the review
|-
| CDISCglossary||role||control group. The group of subjects
|-
| CDISCglossary||person role||coordinating investigator.
|-
| CDISCglossary||statistics||covariate (prognostic). Factor or condition that influences outcome of a trial.
|-
| CDISCglossary||document||curriculum vitae (cv).
|-
| CDISCglossary||organization role||data and safety monitoring board (DSMB). See data monitoring committee.
|-
| CDISCglossary||document||data clarification form. A form used to query an investigator and collect feedback to resolve questions
|-
| CDISCglossary||data||data integrity. An attribute of data
|-
| CDISCglossary||data||data model. Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use.
|-
| CDISCglossary||protocol||decision rule. Succinct statement of
|-
| CDISCglossary||data||discrepancy. The failure of a datapoint to pass a validation check. NOTE:
|-
| CDISCglossary||||disease. Any deviation from or interruption of the normal structure orfunction of a part, organ, or system of the body as manifested by characteristic symptoms and signs.
|-
| CDISCglossary||quality||dosage form. Physical characteristicsof a drug product, (e.g., tablet,capsule, or solution) that contains adrug substance, generally
|-
| CDISCglossary||quality||dosage strength. 1. Proportion of active substance to excipient, measured in units of volume or concentration. 2.The strength of a drug product. tells how much of the active ingredient is present in each dosage.
|-
| CDISCglossary||science||drug development process. The
|-
| CDISCglossary||role||drug product. 1. A dosage form thatcontains an active drug ingredient orplacebo; 2. A finished dosage form asdescribed in regulations. [SPL Glossary]
|-
| CDISCglossary||data||effect. An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments.
|-
| CDISCglossary||quality||effectiveness. The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.
|-
| CDISCglossary||quality||efficacy. The capacity of a drug ortreatment to produce beneficial effects
|-
| CDISCglossary||time||element. 1. In trial design, a basicbuilding block for time within a clinicaltrial comprising the followingcharacteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.
|-
| CDISCglossary||data||endpoint. Variable that pertains tothe efficacy or safety evaluations of a
|-
| CDISCglossary||aggregate population||enrollment (cumulative). Current enrollment as well as any ever-enrolled subjects who have ended participation.
|-
| CDISCglossary||time||epoch. An interval of time in the planned conduct of a study during which the treatment is consistent. Synonyms: period, cycle, phase, stage.
|-
| CDISCglossary||quality||equipoise. A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.
|-
| CDISCglossary||document||eSource document (electronic
|-
| CDISCglossary||organization role||Ethics Committees
|-
| CDISCglossary||protocol||exclusion criteria. List of
|-
| CDISCglossary||conclusion||finding. A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.
|-
| CDISCglossary||conclusion||global assessment variable. A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator’s overall impression about the state or change in state of asubject.
|-
| CDISCglossary||hypothesis||hypothesis to test. In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesistest, which generates a P value.
|-
| CDISCglossary||protocol||inclusion criteria. The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population.See also exclusion criteria.independent data monitoring
|-
| CDISCglossary||computer||Internet service provider (ISP). A
|-
| CDISCglossary||quality||inter-rater reliability. The property of scales yielding equivalent results when used by different raters ondifferent occasions.
|-
| CDISCglossary||role||intervention. The drug, device, therapy or process under investigationin a clinical trial which has an effect on outcome of interest in a study: e.g.,health-related quality of life, efficacy,safety, pharmacoeconomics. Synonyms:therapeutic intervention, medical product. See also: test articles; devices;
|-
| CDISCglossary||role||investigational product. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
|-
| CDISCglossary||role||investigational treatment. An intervention under investigation in a clinical trial.
|-
| CDISCglossary||||investigator/institution. An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
|-
| CDISCglossary||data||item definition. 1. In a questionnaire or form to be completed in a clinical trial, the specification of a question and the specification of the format and semantics of the response.2. Formal specification of the properties of an item or field of data in an eClinical trial.
|-
| CDISCglossary||||Janus. 1. A logical design conceivedby Dr. Norman Stockbridge of the FDAfor a data warehouse intended to integrate submission data, protocol descriptions and analysis plans from clinical and animal studies into as an FDA review environment that uses a set of validated, standards-based tools toallow reproducible cross-study, datamining and retrospective comparative analysis. 2) the name assigned to acomponent of the NCI’s CaBIG ClinicalResearch Information Exchange (CRIX)
|-
| CDISCglossary||time||last subject out/complete(LSC/LPC or LSO/LPO). 1. The dateand time when the last subject hasreached a planned or achievedmilestone representing the completionof the trial. 2. The last subject tocomplete a trial. See also subject, pt, completion
|-
| CDISCglossary||time||legal authentication. A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document.
|-
| CDISCglossary||role||medicinal product. Synonym for therapeutic intervention, but usually a drug.
|-
| CDISCglossary||data model||model. A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context, e.g., clinical trial data.
|-
| CDISCglossary||document||Nuremberg Code. Code of ethics,set forth in 1947, for conducting human medical research.objective. The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing).
|-
| CDISCglossary||data||objective measurement. A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment. See also outcome, patient-reported outcome;
|-
| CDISCglossary||time||open to enrollment. The status of a study such that a subject can be enrolled into that study.
|-
| CDISCglossary||standard||operational model. The set of CDISC data standards (including ODMand LAB) used to capture and archive data from clinical trials.
|-
| CDISCglossary||data||outcome (of adverse event).Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved,recovering/ resolving, not recovered/notresolved, recovered /resolved with sequelae, fatal, or unknown
|-
| CDISCglossary||data||outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective
|-
| CDISCglossary||mixed||packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.
|-
| CDISCglossary||data||patient-reported outcome Patient-reported outcomes are subjective measurements.
|-
| CDISCglossary||role||per-protocol analysis set. The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.
|-
| CDISCglossary||protocol||pharmacogenetic test. An assay intended to study inter individual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.
|-
| CDISCglossary||study design||phase. Clinical trials are generally categorized into four (sometimes five) phases A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
|-
| CDISCglossary||role||primary variable. An outcome of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation.NOTE: Differences between groups in the primary and secondary variable(s)are believed to be the result of the group-specific interventions.
|-
| CDISCglossary||role||product. 1. Drug product: A finished dosage form that contains a drug substance. 2. A physical entity that isintended to diagnose, treat, or preventa disease or other abnormal condition,and subject to regulatory authority
|-
| CDISCglossary||protocol||protocol approval (Sponsor).Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated
|-
| CDISCglossary||unscheduled||protocol violation. A significant departure from processes or procedures that were required by the protocol.Violations often result in data that are not deemed evaluable for a per protocol analyis, and may require that the subject(s) who violate the protocol
|-
| CDISCglossary||person role||proxy respondent. Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. Compare to observer assessment.
|-
| CDISCglossary||statistics||qualitative variable. One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categoriesaccording to their attributes.
|-
| CDISCglossary||quality||quality of life. A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships,personal beliefs and their relationships to salient features of the environment.
|-
| CDISCglossary||document||query. A request for clarification on a data item collected for a clinical trial;specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.
|-
| CDISCglossary||statistics||random number table.
|-
| CDISCglossary||statistics||random sample. Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.randomization. The process of assigning trial subjects to treatment or
|-
| CDISCglossary||data||raw data. Data as originally collected.Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes,evaluations, data recorded by automated instruments)
|-
| CDISCglossary||time||recruitment period. Time period during which subjects are or are planned to be enrolled in a clinical trial.
|-
| CDISCglossary||data model||Reference Information Model(RIM). An information model used as the ultimate defining reference for al lHL7 standards.
|-
| CDISCglossary||data||registry. A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
|-
| CDISCglossary||quality||reliability, psychometric. The degree to which a psychometric “instrument” is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time
|-
| CDISCglossary||hypothesis||research hypothesis. The proposition that a study sets out to support (or disprove); for example,“blood pressure will be lowered by[specific endpoint] in subjects who receive the test product.” See also null hypothesis.
|-
| CDISCglossary||data||Researcher’s records of subjects/patients, such as patient medical charts, hospital records, X-rays,and attending physician’s notes. NOTE:These records may or may not accompany an application to a Regulatory Authority, but must be kept
|-
| CDISCglossary||quality||risk. In clinical trials, the probability of harm or discomfort for subjects. NOTE:Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat,for example, will be expected to have a low incidence of troubling side effects.
|-
| CDISCglossary||quality||safety and tolerability. The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs andsymptoms), and other special safetytests (e.g., ECGs, ophthalmology). The tolerability of the medical productrepresents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]
|-
| CDISCglossary||quality||safety. Relative freedom from harm.In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests andprocedures, psychiatric evaluation,
|-
| CDISCglossary||||semantic. In the context of a technical specification, semantic refers to the meaning of an element asdistinct from its syntax. Syntax canchange without affecting semantics.
|-
| CDISCglossary||study design||single-blind study. A study in which one party, either the investigatoror the subject, does not know which medication or placebo is administered to the subject; also called single masked study. See also blind study,double-blind study, triple-blind study.
|-
| CDISCglossary||data||source data. All information in original records and certified copies of original records of clinical findings,observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
|-
| FCR||||1. Basic vs applied
|-
| FCR||||1. Hierarchical – show vertical relationships
|-
| FCR||quality||1. Morbidity
|-
| FCR||data||1. Outcome assessment
|-
| FCR||||1. Physical
|-
| FCR||protocol||1. Tradition (precedent)
|-
| FCR||study design||10. Historical research
|-
| FCR||quality||10. self-assessment of functional capacity
|-
| FCR||role||10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
|-
| FCR||||11. Propositions – state the relationships between variables
|-
| FCR||quality||11. quality of life
|-
| FCR||study design||11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
|-
| FCR||data model||12. Model – symbolic representation of the elements of a system
|-
| FCR||study design||12. Single-subject design
|-
| FCR||conclusion||13. Inductive theory – theory based on empirically verifiable observations
|-
| FCR||study design||13. Sequential clinical trial
|-
| FCR||study design||14. Evaluation research – assessment of the success of a program or policy
|-
| FCR||conclusion||14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
|-
| FCR||conclusion||15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
|-
| FCR||study design||15. Quasi-experimental research
|-
| FCR||protocol||16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
|-
| FCR||study design||16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
|-
| FCR||protocol||17. Deduction – theory testing
|-
| FCR||study design||17. Qualitative vs quantitative research
|-
| FCR||protocol||18. Induction – theory development
|-
| FCR||data||2. Acute conditions and chronic conditions
|-
| FCR||protocol||2. Authority (trusted expert)
|-
| FCR||quality||2. mortality
|-
| FCR||study design||2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
|-
| FCR||||2. Schematic
|-
| FCR||time||2. Temporal – order concepts in time and states a sequence of events
|-
| FCR||study design||3. Case study – description of one or more patients
|-
| FCR||data||3. length of stay
|-
| FCR||||3. Process
|-
| FCR||time||3. Quantitative – frequency or duration of a specific behavior
|-
| FCR||data||3. Sources of knowledge
|-
| FCR||protocol||3. Trial and error
|-
| FCR||study design||4. Developmental research – description of pattern of change over time
|-
| FCR||protocol||4. Logical reasoning - Deductive reasoning, Inductive reasoning
|-
| FCR||data||4. readmission
|-
| FCR||||4. Statistical
|-
| FCR||science||4. Types of research
|-
| FCR||study design||5. Normative research – establishing normal values
|-
| FCR||quality||5. Physical
|-
| FCR||protocol||5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
|-
| FCR||study design||6. Qualitative research – gathering data through interview or observation
|-
| FCR||quality||6. social
|-
| FCR||data model||6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
|-
| FCR||study design||7. Cohort or case-control studies – establish associations
|-
| FCR||hypothesis||7. Hypothesis - specific predictions based on a theory.
|-
| FCR||quality||7. psychological well-being
|-
| FCR||data||8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
|-
| FCR||study design||8. Methodological studies – establish reliability and validity of a new method
|-
| FCR||quality||8. Patient satisfaction
|-
| FCR||data||9. Constructs – concepts that represent non-observable behaviors or events
|-
| FCR||quality||9. patient preference
|-
| FCR||study design||9. Secondary analysis – exploring new relationships in old data
|-
| MUSC||data||accrual rate
|-
| MUSC||role||active control
|-
| MUSC||||adherence
|-
| MUSC||unscheduled||adjustment
|-
| MUSC||unscheduled||adverse event
|-
| MUSC||data||allocation ratio
|-
| MUSC||statistics||alternative hypothesis
|-
| MUSC||data||analysis datasets
|-
| MUSC||protocol||assessment
|-
| MUSC||statistics||assessment bias
|-
| MUSC||time||assessment schedule
|-
| MUSC||||as-treated
|-
| MUSC||protocol||auditing
|-
| MUSC||study design||balanced design
|-
| MUSC||||baseline
|-
| MUSC||||baseline comparability
|-
| MUSC||statistics||bias
|-
| MUSC||protocol||biased coin randomizaiton
|-
| MUSC||statistics||binormial
|-
| MUSC||quality||bioequivalence
|-
| MUSC||protocol||blinding
|-
| MUSC||role||block
|-
| MUSC||data||carryover effect
|-
| MUSC||document||case report
|-
| MUSC||document||case report form
|-
| MUSC||study design||case-control design
|-
| MUSC||protocol||censoring
|-
| MUSC||data||clinical trial management system
|-
| MUSC||protocol||cluster randomization
|-
| MUSC||protocol||coding
|-
| MUSC||role||cohort
|-
| MUSC||study design||community intervention trial
|-
| MUSC||quality||comparative treatment efficacy
|-
| MUSC||quality||complaince
|-
| MUSC||role||concurrent controls
|-
| MUSC||statistics||confidence interval
|-
| MUSC||study design||confirmatory trial
|-
| MUSC||role||confounder
|-
| MUSC||role||confounding factor
|-
| MUSC||document||CONSORT statement
|-
| MUSC||||constrain
|-
| MUSC||||context
|-
| MUSC||data||continous
|-
| MUSC||role||controls
|-
| MUSC||study design||crossover
|-
| MUSC||study design||crossover trial
|-
| MUSC||||cross-sectional analysis
|-
| MUSC||organization role||data and safety monitoring board
|-
| MUSC||document||data clarification query
|-
| MUSC||document||data clarification request
|-
| MUSC||time||data collection schedule
|-
| MUSC||protocol||data management
|-
| MUSC||protocol||data management plan
|-
| MUSC||organization role||data safety monitoring committee
|-
| MUSC||data||database
|-
| MUSC||protocol||data-dependent stopping
|-
| MUSC||data||derived data
|-
| MUSC||||deterministic
|-
| MUSC||study design||diagnostic trial
|-
| MUSC||||dichotomous
|-
| MUSC||data||discret
|-
| MUSC||conclusion||dose finding
|-
| MUSC||protocol||double blinding
|-
| MUSC||protocol||double masking
|-
| MUSC||unscheduled||dropouts
|-
| MUSC||quality||drug lot
|-
| MUSC||unscheduled||early termination
|-
| MUSC||quality||efficacy
|-
| MUSC||protocol||electronic data capture
|-
| MUSC||protocol||eligibility
|-
| MUSC||data||endpoint
|-
| MUSC||quality||equipoise
|-
| MUSC||study design||equivalence trials
|-
| MUSC||protocol||estimate
|-
| MUSC||protocol||evaluation
|-
| MUSC||organization role||excecutive committee
|-
| MUSC||protocol||exclusion criteria
|-
| MUSC||||expectation bias
|-
| MUSC||||experiment
|-
| MUSC||study design||factorial design
|-
| MUSC||protocol||follow-up
|-
| MUSC||||group sequential
|-
| MUSC||role||historic controls
|-
| MUSC||statistics||imbalance
|-
| MUSC||protocol||imputation of missing data
|-
| MUSC||protocol||inclusion criteria
|-
| MUSC||protocol||informed consent
|-
| MUSC||organization role||institutional review board
|-
| MUSC||protocol||intention to treat
|-
| MUSC||role||intention to treat population
|-
| MUSC||statistics||interaction
|-
| MUSC||protocol||interim analysis
|-
| MUSC||||intersubject
|-
| MUSC||role||intervention
|-
| MUSC||||intrasubject
|-
| MUSC||document||investigational new drug (IND) application
|-
| MUSC||quality||investigator competence
|-
| MUSC||||local control
|-
| MUSC||data||lost to follow-up
|-
| MUSC||statistics||main effect
|-
| MUSC||protocol||masking
|-
| MUSC||person role||medical safety monitor
|-
| MUSC||protocol||meta-analysis
|-
| MUSC||protocol||minimization randomization
|-
| MUSC||||minority representation
|-
| MUSC||data||missing data
|-
| MUSC||protocol||monitoring
|-
| MUSC||study design||multi-center
|-
| MUSC||study design||multi-site
|-
| MUSC||statistics||multivariable
|-
| MUSC||conclusion||negative findings
|-
| MUSC||statistics||nesting design
|-
| MUSC||document||new drug application (NDA)
|-
| MUSC||statistics||Neyman allocation
|-
| MUSC||unscheduled||nonadherence
|-
| MUSC||unscheduled||noncomplaince
|-
| MUSC||||noninferiority
|-
| MUSC||statistics||null hypothesis
|-
| MUSC||data||observation
|-
| MUSC||statistics||odds
|-
| MUSC||statistics||odds ratio
|-
| MUSC||statistics||one-sided test
|-
| MUSC||||optimal allocation
|-
| MUSC||quality||over-the -count (OTC)
|-
| MUSC||study design||parallel design
|-
| MUSC||protocol||permuted block randomization
|-
| MUSC||role||per-protocol population
|-
| MUSC||study design||phase I trial
|-
| MUSC||study design||phase II trial
|-
| MUSC||study design||phase IIA
|-
| MUSC||study design||phase IIB
|-
| MUSC||study design||phase IIB
|-
| MUSC||study design||phase III trial
|-
| MUSC||study design||phase IV trial
|-
| MUSC||study design||pivotal trials
|-
| MUSC||study design||placebo controlled
|-
| MUSC||protocol||play the winner
|-
| MUSC||role||plecabo
|-
| MUSC||aggregate||population
|-
| MUSC||conclusion||positive findings
|-
| MUSC||statistics||power
|-
| MUSC||study design||prevention trials
|-
| MUSC||||primary efficacy
|-
| MUSC||conclusion||primary outcome
|-
| MUSC||data||primary response
|-
| MUSC||person role||principal investigator
|-
| MUSC||role||prognostic factor
|-
| MUSC||protocol||project management
|-
| MUSC||protocol||project management plan
|-
| MUSC||protocol||protocal complaince
|-
| MUSC||protocol||protocol
|-
| MUSC||unscheduled||protocol exception
|-
| MUSC||unscheduled||protocol violation
|-
| MUSC||statistics||pseudorandom
|-
| MUSC||statistics||p-value
|-
| MUSC||protocol||quality assurance
|-
| MUSC||protocol||random play the winner
|-
| MUSC||protocol||recruitment
|-
| MUSC||protocol||regulatory management
|-
| MUSC||data||repeat measurement
|-
| MUSC||data||response
|-
| MUSC||protocol||response adaptive randomization
|-
| MUSC||study design||retrospective design
|-
| MUSC||quality||safety
|-
| MUSC||statistics||sample size
|-
| MUSC||||sample size inflation
|-
| MUSC||protocol||screening
|-
| MUSC||||selection bias
|-
| MUSC||study design||sequential design
|-
| MUSC||unscheduled||serious adverse event
|-
| MUSC||role||sham treatment
|-
| MUSC||study design||single-center
|-
| MUSC||study design||single-site
|-
| MUSC||document||source document
|-
| MUSC||person role||sponsor
|-
| MUSC||protocol||statistical analysis plan
|-
| MUSC||statistics||statistical significant
|-
| MUSC||organization role||steering committee
|-
| MUSC||protocol||stop rule
|-
| MUSC||statistics||stratification
|-
| MUSC||person role||study coordinator
|-
| MUSC||role||subject
|-
| MUSC||quality||superiority
|-
| MUSC||conclusion||surrogate outcome
|-
| MUSC||time||time to event
|-
| MUSC||protocol||titration
|-
| MUSC||quality||tocxicity
|-
| MUSC||quality||tolerability
|-
| MUSC||role||treatment
|-
| MUSC||||treatment allocation
|-
| MUSC||role||treatment group
|-
| MUSC||unscheduled||treatment-emergenet adverse event (TEAE)
|-
| MUSC||protocol||trilple blinding
|-
| MUSC||protocol||triple masking
|-
| MUSC||statistics||two-sided test
|-
| MUSC||statistics||type I error
|-
| MUSC||statistics||type II error
|-
| MUSC||statistics||univariable
|-
| MUSC||protocol||urn randomization
|-
| MUSC||||varibility
|-
| MUSC||time||washout period
|-
| MUSC||protocol||withdrawal consent
|-
| RCT||role||Analyzed population
|-
| RCT||time||Anchored-time
|-
| RCT||conclusion||Ancillary-outcome
|-
| RCT||data||Baseline
|-
| RCT||protocol||Blinding
|-
| RCT||protocol||Blinding-method
|-
| RCT||study design||Cointervention*
|-
| RCT||study design||Comparison-arm
|-
| RCT||quality||Cost
|-
| RCT||role||Crossover population
|-
| RCT||time||Date
|-
| RCT||||Device
|-
| RCT||time||Double-anchored-interval
|-
| RCT||role||Drug
|-
| RCT||protocol||Drug-step
|-
| RCT||time||Duration
|-
| RCT||role||Eligible-population
|-
| RCT||role||Enrolled-population
|-
| RCT||role||Excluded population
|-
| RCT||protocol||Exclusion-rule
|-
| RCT||protocol||Executed-protocol
|-
| RCT||protocol||Executed-secondary-study-protocol
|-
| RCT||study design||Experimental-arm
|-
| RCT||protocol||Follow-up activity
|-
| RCT||role||Funder
|-
| RCT||protocol||Inclusion-rule
|-
| RCT||organization||Institution
|-
| RCT||protocol||Intended-protocol
|-
| RCT||protocol||Intended-secondary-study-protocol
|-
| RCT||time||Interval
|-
| RCT||study design||Intervention*
|-
| RCT||study design||Intervention-arm
|-
| RCT||protocol||Intervention-step
|-
| RCT||role||Investigator
|-
| RCT||protocol||Non-drug-intervention-step
|-
| RCT||||No-treatment
|-
| RCT||data||Outcome
|-
| RCT||data||Outcomes-followup
|-
| RCT||role||Placebo
|-
| RCT||conclusion||Primary-outcome
|-
| RCT||protocol||Primary-recruitment-flowchart
|-
| RCT||protocol||Procedure
|-
| RCT||protocol||Protocol
|-
| RCT||unscheduled||Protocol-change
|-
| RCT||protocol||Protocol-concept
|-
| RCT||role||Randomized-population
|-
| RCT||||Reason
|-
| RCT||role||Recruited-population
|-
| RCT||protocol||Recruitment-flowchart
|-
| RCT||role||Screened-population
|-
| RCT||conclusion||Secondary-outcome
|-
| RCT||study design||Secondary-study
|-
| RCT||protocol||Secondary-study-protocol
|-
| RCT||data||Side-effect
|-
| RCT||time||Single-anchored-interval
|-
| RCT||role||Site-enrollment
|-
| RCT||protocol||Stopping-rule
|-
| RCT||role||Study-arm population
|-
| RCT||organization role||Study-committee
|-
| RCT||conclusion||Study-outcome
|-
| RCT||organization role||Study-site
|-
| RCT||time||Timepoint
|-
| RCT||time||Time-range
|-
| RCT||role||Treatment-assignment
|-
| RCT||||Trial
|-
| RCT||role||Trial-participant
|-
| RCT||data||Withdrawal-reason
|-
|
|}

OCI Term Compilation (Jennifer)

2007-05-03T14:27:42Z

Jalee:

Go back to [[CTO:Main Page]]

Download the term list here:
[[Image:CTO-may3.xls]]

OCI Term Compilation (Jennifer)

2007-05-03T14:26:29Z

Jalee: New page: Image:CTO-may3.xls

[[Image:CTO-may3.xls]]

File:CTO-may3.xls

2007-05-03T14:25:07Z

Jalee: Compilation of terms from several glossaries and initial mappings to OBI

Compilation of terms from several glossaries and initial mappings to OBI

OCI:Main Page

2007-05-03T14:20:34Z

Jalee: /* Ontology Development Items */

=CTO - Clinical Trials Ontology=

==About CTO==

The goal of the CTO Working Group is to foster the creation and dissemination of a reference ontology (high-quality controlled structured vocabulary) for the annotation of the results of clinical trials.

==Recent Developments==

==Conference Call Information==
* [[Conference Call Schedule]]
* [[Call-in Information]]
* [[Conference Call Agendas]]
* [[Conference Call Minutes]]
* [[Action Items]]

==Meetings==
* [[Upcoming Meetings]]
* [[Meetings Attended]]

==Communities and Working Group (WG) Participants==
* [[CTO WG Chairs]]
* [[CTO Curators]]
* [[Other members of CTO WG]]

==Draft version of CTO==

==Ontology Development Items==
* [[Design Principles]]
* [[Term Lists]]
* [[High-level Concepts]]
* [[High-level Concepts v0.2]]
* [[Initial CTO-OBI Mapping]]
* [[CTO Term Compilation (Jennifer)]]

==CTO Development Policies==
* [[Ontology Metadata Policy (from OBI)]]
* [[CTO Check-out Procedure Policy]]
* [[CTO Working Group Membership Policy]]

==Publications==

CTO Google group: http://groups.google.com/group/CTOtlg

CTO Google mailing list: mailto:CTOtlg@googlegroups.com

CTO SVN repository: http://cto.googlecode.com/svn/trunk/CTO.owl (save as CTO.owl)

==CTO Wiki information==

Conference Call Schedule

2007-04-19T16:51:35Z

Jalee:

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'''Meeting changes'''
*NO CALL on Thursday, April 26, 2007. Action items to be accomplished via wiki and email.

'''Scheduled meetings:'''
*WEEKLY starting April 19 at 9:00am PST, 11:00am CST, noon EST, 6:00pm Germany

*Thursday April 12, 2007 at 9:30 EDT

Minutes from 04/19/07 Conference Call

2007-04-19T16:47:29Z

Jalee: New page: Go back to CTO:Main Page '''Attendees:''' Jim, Wenle, Trish, Cristian, Simona, Jamie, Richard '''Minutes''' *Jennifer unable to attend and give OBI overview. *Simona posted 2 te...

Go back to [[CTO:Main Page]]

'''Attendees:'''

Jim, Wenle, Trish, Cristian, Simona, Jamie, Richard

'''Minutes'''

*Jennifer unable to attend and give OBI overview.

*Simona posted 2 terms lists. Wenle evaluated them and concluded that we need an expert to assemble documents and prepare term lists to cover clinical trial design, management, conduction and analysis.

*Our term lists were not intended to be comprehensive at this point. These 2 lists definitely don’t cover anything, but are selective for the higher level.

*We should define the high-level structure that might serve as ontology branches starting with Richard’s high-level concepts rough draft posted on the wiki. In parallel, we can assign membership of terms from our term lists into branches. The next step is to pick one branch and try to flesh out the ontology just in that branch. This would demonstrate the scope/domain of the CTO as well as an example of a detailed structure within one branch for the May meeting.

*Action items to accomplish via wiki and e-mail 
1. Play around with high-level classes on wiki. Restructure or add classes but do not delete anything. 
2. Continue to add terms to term lists 
3. assemble term lists to eliminate any redundancy and categorize terms into branches 
4. select a branch to develop more fully 
5. Find some specific examples of clinical trials that could be used to validate high-level structure and terms 

*Challenges
1. How do we determine whether our term list is comprehensive enough? Probably need to engage experts to help us do this. 

*Note: next Thursday’s meeting to be cancelled

Conference Call Minutes

2007-04-19T16:44:50Z

Jalee:

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* [[Minutes from 04/19/07 Conference Call]]
* [[Minutes from 04/12/07 Conference Call]]

Action items from 04/19/07 call

2007-04-19T16:43:47Z

Jalee: New page: Go back to CTO:Main Page Action items to accomplish via wiki and e-mail 1. Play around with high-level classes on wiki. Restructure or add classes but do not delete anything.<br...

Go back to [[CTO:Main Page]]

Action items to accomplish via wiki and e-mail 
1. Play around with high-level classes on wiki. Restructure or add classes but do not delete anything. 
2. Continue to add terms to term lists 
3. assemble term lists to eliminate any redundancy and categorize terms into branches 
4. select a branch to develop more fully 
5. Find some specific examples of clinical trials that could be used to validate high-level structure and terms

Action Items

2007-04-19T16:42:14Z

Jalee:

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*[[Action items from 04/19/07 call]]

Conference Call Schedule

2007-04-19T15:40:11Z

Jalee:

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*WEEKLY starting April 19 at 9:00am PST, 11:00am CST, noon EST, 6:00pm Germany

*Thursday April 12, 2007 at 9:30 EDT

OCI Working Group Membership Policy

2007-04-19T15:39:33Z

Jalee:

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'''To be developed'''

OCI Check-out Procedure Policy

2007-04-19T15:39:11Z

Jalee:

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[Adapted from Cristian Cocos (username: Aqualung)] When planning to work on the ontology:

1. Make sure, via Skype, that no one is working on the ontology right now,
so that you can be certain that the ontology you will be downloading is the
latest version.

2. Let everybody know that you will be working on the ontology for a certain amount of time, starting now. (Offline Skype status, or no reply, will be interpreted as "not working on the ontology, go ahead"! Make sure, then, that you are always online when working on the CTO.)

3. Download the latest CTO version using your SVN client.

4. Read the log, just so you know what has happened to the CTO since you last
updated it.

5. Do your work, keeping track religiously of all the changes you make. All of
this will go into the log. Will be making heavy use of abbreviations
(ac=added class, mc=modified class, dc=deleted class etc.). The log should
be as exhaustive as possible.

6. When done, you should save all changes locally, and upload them onto the server.
Make sure you fill out the log when uploading (you will be prompted to do
that at the time of the upload).

7. Let everyone know via Skype that you have just uploaded the latest
version, and that you are done with the CTO for now.

Ontology Metadata Policy (from OBI)

2007-04-19T15:38:50Z

Jalee:

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'''Minimal requirement for term annotations in the CTO (metadata)'''

Mandatory metadata: MUST be provided
*preferred_term: The concise, meaningful, and human-friendly name for a class or property preferred by the ontology developers. (US-English)
*definition: The official CTO definition, explaining the meaning of a class or property. Shall be Aristotelian, formalized and normalized. Can be augmented with informal examples to further clarify the meaning of the term.
*definition_editor: The name of the editor of the definition.
*definition_source: An unambiguous and traceable reference to the source of the definition. Examples: ISBN, URI plus date, MeSH Term, PUBMED ID, DOI.
*curation_status: The curation status of a class or property. The allowed values come from an enumerated list of predefined terms. Examples: raw import, obo definition incomplete, graph position temporary, uncurated, curation approved
*example: A phrase describing how a term should be used. May also include other kinds of examples, such as widely known subclasses or instances of the class.
Optional metadata: SHOULD be provided
*alternative_term: An alternative name for a class or property which means the same thing, i.e. semantically equivalent, as the preferred_term.
*alternative_term_tag: A tag to indicate sets of alternative terms. Examples: toxicogenomics_community, abbreviation.
*alternative_term_source: An unambiguous and traceable reference to the source of the alternative_term. Examples: ISBN, URI plus date, MeSH Term, PUBMED ID, DOI.
*editor_note: An administrative note intended for the editor. It will not be included in the publication version of the ontology, so it should contain nothing necessary for end users to understand the ontology.
*external_class: An annotation property that indicates external classes, including their subtrees, for a given anchor class.

Initial CTO-OBI Mapping

2007-04-19T15:38:30Z

Jalee:

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[[Image:CTOBI.xls]]

High-level Concepts

2007-04-19T15:38:09Z

Jalee:

Term Lists

2007-04-19T15:37:41Z

Jalee:

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'''RCT Schema Terms'''

The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]

We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:
[[Media:ForCTO_041807.doc|ForCTO_041807.doc]]

*Secondary-study
*Trial
*Anchored-time
*Interval
*Double-anchored-interval
*Single-anchored-interval
*Timepoint
*Time-range
*Duration
*Date
*Exclusion-rule
*Inclusion-rule
*Recruitment-flowchart
*Primary-recruitment-flowchart
*Recruited-population
*Randomized-population
*Enrolled-population
*Eligible-population
*Screened-population
*Excluded population
*Analyzed population
*Crossover population
*Study-arm population
*Site-enrollment
*Protocol-concept
*Follow-up activity
*Protocol-change
*Treatment-assignment
*Protocol
*Executed-protocol
*Intended-protocol
*Reason
*Withdrawal-reason
*Outcomes-followup
*Secondary-study-protocol
*Intended-secondary-study-protocol
*Executed-secondary-study-protocol
*Stopping-rule
*Cost
*Outcome
*Baseline
*Study-outcome
*Primary-outcome
*Secondary-outcome
*Ancillary-outcome
*Side-effect
*Study-site
*Trial-participant
*Investigator
*Study-committee
*Funder
*Institution
*Blinding
*Blinding-method
*Intervention-step
*Drug-step
*Non-drug-intervention-step
*Intervention-arm
*Comparison-arm
*Experimental-arm
*Cointervention*
*Intervention*
*Procedure
*Device
*Drug
*No-treatment
*Placebo

'''Foundations of Clinical Research (Scheuermann list)'''

#Outcome assessment
##Morbidity
##mortality
##length of stay
##readmission
##Physical
##social
##psychological well-being
##Patient satisfaction
##patient preference
##self-assessment of functional capacity
##quality of life
#Acute conditions and chronic conditions
#Sources of knowledge
##Tradition (precedent)
##Authority (trusted expert)
##Trial and error
##Logical reasoning - Deductive reasoning, Inductive reasoning
##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
#Types of research
##Basic vs applied
##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
##Case study – description of one or more patients
##Developmental research – description of pattern of change over time
##Normative research – establishing normal values
##Qualitative research – gathering data through interview or observation
##Cohort or case-control studies – establish associations
##Methodological studies – establish reliability and validity of a new method
##Secondary analysis – exploring new relationships in old data
##Historical research
##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
##Single-subject design
##Sequential clinical trial
##Evaluation research – assessment of the success of a program or policy
##Quasi-experimental research
##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
##Qualitative vs quantitative research
#Research process
##Phase I: Identify the research question
###Identify the research problem
###Review of literature to provide a theoretical framework
###Identify variables
###State hypothesis
##Phase II: Design the study
###Design the protocol
###Choose a sample
##Phase III: Methods
###Collect data
###Reduce data
##Phase IV: Data analysis
###Analyze data
###Interpret findings
##Phase V: Communication
###Report findings
###Suggest future studies
#Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
#Hypothesis - specific predictions based on a theory.
#Concepts – abstraction that allow us to classify natural phenomena and empirical observations
#Constructs – concepts that represent non-observable behaviors or events
#Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
#Propositions – state the relationships between variables
##Hierarchical – show vertical relationships
##Temporal – order concepts in time and states a sequence of events
##Quantitative – frequency or duration of a specific behavior
#Model – symbolic representation of the elements of a system
##Physical
##Schematic
##Process
##Statistical
#Inductive theory – theory based on empirically verifiable observations
#Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
#Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
#Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
#Deduction – theory testing
#Induction – theory development

Terms collected by Wenle Zhao from MUSC
* adherence
* accrual rate
* active control
* adjustment
* type I error
* type II error
* balanced design
* baseline
* bias
* prognostic factor
* confounding factor
* block
* permuted block randomization
* minimization randomization
* biased coin randomizaiton
* urn randomization
* response adaptive randomization
* play the winner
* random play the winner
* case report
* case report form
* data clarification request
* data clarification query
* censoring
* efficacy
* safety
* treatment
* intervention
* crossover
* comparative treatment efficacy
* interim analysis
* deterministic
* stop rule
* phase I trial
* phase II trial
* phase III trial
* phase IV trial
* dichotomous
* dose finding
* dropouts
* eligibility
* experiment
* estimate
* follow-up
* sequential design
* group sequential
* endpoint
* intention to treat
* data-dependent stopping
* lost to follow-up
* meta-analysis
* monitoring
* data and safety monitoring board
* institutional review board
* null hypothesis
* alternative hypothesis
* nesting design
* observation
* odds
* odds ratio
* parallel design
* plecabo
* power
* sample size
* primary outcome
* surrogate outcome
* protocol
* per-protocol population
* intention to treat population
* pseudorandom
* p-value
* treatment allocation
* imbalance
* selection bias
* expectation bias
* statistical significant
* stratification
* univariable
* multivariable
* adverse event
* serious adverse event
* cluster randomization
* community intervention trial
* coding
* complaince
* protocal complaince
* protocol violation
* protocol exception
* auditing
* allocation ratio
* assessment
* assessment bias
* early termination
* informed consent
* withdrawal consent
* source document
* principal investigator
* study coordinator
* data management
* project management
* regulatory management
* case-control design
* blinding
* double blinding
* tocxicity
* cohort
* evaluation
* confidence interval
* confirmatory trial
* confounder
* CONSORT statement
* constrain
* context
* diagnostic trial
* controls
* concurrent controls
* historic controls
* crossover trial
* carryover effect
* recruitment
* washout period
* equivalence trials
* statistical analysis plan
* data management plan
* project management plan
* sponsor
* inclusion criteria
* equipoise
* exclusion criteria
* factorial design
* interaction
* main effect
* one-sided test
* two-sided test
* missing data
* imputation of missing data
* investigator competence
* local control
* masking
* double masking
* triple masking
* trilple blinding
* data safety monitoring committee
* minority representation
* negative findings
* positive findings
* noninferiority
* nonadherence
* sample size inflation
* noncomplaince
* repeat measurement
* time to event
* medical safety monitor
* pivotal trials
* prevention trials
* assessment schedule
* data collection schedule
* quality assurance
* electronic data capture
* clinical trial management system
* database
* analysis datasets
* retrospective design
* screening
* sham treatment
* steering committee
* excecutive committee
* baseline comparability
* optimal allocation
* Neyman allocation
* response
* intersubject
* subject
* intrasubject
* population
* varibility
* binormial
* continous
* derived data
* discret
* primary efficacy
* primary response
* placebo controlled
* single-site
* single-center
* multi-site
* multi-center
* superiority
* bioequivalence
* treatment group
* titration
* tolerability
* phase IIA
* phase IIB
* phase IIB
* investigational new drug (IND) application
* new drug application (NDA)
* over-the -count (OTC)
* drug lot
* treatment-emergenet adverse event (TEAE)
* as-treated
* cross-sectional analysis

Design Principles

2007-04-19T15:37:19Z

Jalee:

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== Goals of the Clinical Trial Ontology Initiative==

The proposed CTO should:

(1) fully and faithfully capture the types of entities and relationships involved in clinical trials of any experimental design

(2) comprehend terms like: ''cohort, randomization, placebo, response, efficacy, control, protocol, null hypothesis, confidence interval, finding, biomarker, primary outcome, secondary outcome, intervention group, experimental design,'' etc., including also major relevant statistical terms and terms drawn from resources such as the CDISC [http://www.cdisc.org/glossary/clinicalterminologyv4.pdf glossary] and
all terms needed for the task of meta-analysis of clinical trials;

(3) organize these terms in a structured way, providing definitions and logical relations designed to enhance retrieval of, reasoning with, and integration of the data annotated in its terms.

(4) support trial bank interoperation

(5) form an integral part of the more comprehensive framework of the Ontology for Biomedical Investigations [http://obi.sourceforge.net/ OBI], which itself forms part of the [http://obofoundry.org/ OBO Foundry]

(6) draw on and seek maximal alignment with existing clinical trial ontologies, including the [http://smi.stanford.edu/smi-web/research/details.jsp?PubId=1227 Epoch ontology] used by the [http://www.immunetolerance.org/ Immune Tolerance Network] and the [http://rctbank.ucsf.edu/ontology/outline/index.htm RCT Schema] ontology used by the [http://rctbank.ucsf.edu/ Trial Bank Project]

(7) rest on a clear understanding of the relation between CTO and an epidemiology study ontology

(8) rest on a clear understanding of the relation between CTO and data-model-oriented initiatives such as CDISC and BRIDG.

(9) meet the requirements of the [http://obofoundry.org OBO Foundry], and in particular support an adequate treatment of the distinction between ''types'' (''surgical intervention'', ''tumor'', ''human being'') and ''instances'' (Jane's oophorectomy, John's tumor, Fritz)

Other members of OCI WG

2007-04-19T15:36:50Z

Jalee:

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* [[Matthias Brochhausen]]
* [[Simona Carini]]
* [[Amar K. Das]]
* [[Dave Parrish]]
* [[Ida Sim]]
* [[Barry Smith]]

OCI Curators

2007-04-19T15:36:25Z

Jalee:

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* [[Cristian Cocos]]
* [[W. Jim Zheng]]
* [[Wenle Zhao]]
* [[Jamie Lee]]

OCI WG Chairs

2007-04-19T15:35:57Z

Jalee:

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* [[Jennifer Fostel]]
* [[Richard Scheuermann]]

Upcoming Meetings

2007-04-19T15:35:30Z

Jalee:

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'''May 16-17, 2007'''

[[Workshop on Clinical Trial Ontology]], Bethesda, MD