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aCRFAnnotated case report form

ADaM

Analysis Data Model

CDASH

Clinical Data Acquisition Standards Harmonization Project

CDISC

Clinical Data Interchange Standards Consortium

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 codelist 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

GGGGlobal Governance Group

NCI

National Cancer Institute

NSVNon-standard variable

Patient

A recipient of medical treatment

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

SDTMIG-PGxSDTM Implementation Guide for Pharmacogenomics/Genetics

Subject

A participant in a study

TAUGTherapeutic area user guide
TAUG-NutritionTherapeutic Area Data Standards User Guide for Nutritional Research
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