OCI Term Compilation (Jennifer)

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Term lists contributed by Jennifer:


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


May 9, 2007 term list shown below:

source draft category 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
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