OCI Term Compilation (Jennifer)

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Term lists contributed by Jennifer:

• Download May 3, 2007 term list here: Image:CTO-may3.xls
• Download May 9, 2007 term list here: Image:CTO-terms-wAllCDISCglossary.xls

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

May 9, 2007 term list shown below:

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