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Instructions to Developers

This is the preliminary glossary. Add and/or remove entries so that it includes terms used in this standard that readers may wish to look up, and does not include any terms that are not used in the guide.

ADaM

Analysis Data Model

ADaMIG

ADaM Implementation Guide

BRIDG

Biomedical Research Integrated Domain Group

Biomedical ConceptA high-level building block of clinical research and/or healthcare information that encapsulates lower level implementation details like variables and terminologies.

CDASH

Clinical Data Acquisition Standards Harmonization Project

CDISC

Clinical Data Interchange Standards Consortium

CFAST

Coalition for Accelerating Standards and Therapies

Collected

“Collected” refers to information that is recorded and/or transmitted to the sponsor. This includes data entered by the site on CRFs/eCRFs as well as vendor data such as core lab data. This term is a synonym for “captured”.

Controlled Terminology

A finite set of values that represent the only allowed values for a data item. These values may be codes, text, or numeric. A code list is one type of controlled terminology.

CRF

Case report form (sometimes called a case record form). A printed, optical, or electronic document designed to record all required information to be reported to the sponsor for each trial subject.

Domain

A collection of observations with a topic-specific commonality about a subject.

eCRF

Electronic case report form

Foundational Standards

Used to refer to the suite of CDISC standards that describe the clinical study protocol (Protocol), design (Study Design), data collection (CDASH), laboratory work (Lab), analysis (ADaM), and data tabulation (SDTM and SEND). See http://www.cdisc.org/ for more information on each of these clinical data standards.

MedDRA

Medical Dictionary for Regulatory Activities. A global standard medical terminology designed to supersede other terminologies (such as COSTART and ICD9) used in the medical product development process.

NCI EVS

National Cancer Institute (NCI) Enterprise Vocabulary Services

NIH

National Institutes of Health

Patient

A recipient of medical treatment.

PRO

Patient-reported outcome

SDS

Submission Data Standards. Also the name of the team that maintains the SDTM and SDTMIG.

SDTM

Study Data Tabulation Model

SDTMIG

SDTM Implementation Guide (for Human Clinical Trials)

SHARE

Shared Health and Clinical Research Electronic Library. CDISC’s metadata repository.

Subject

A participant in a study.   

UML

Unified Modeling Language

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