|aCRF||Annotated case report form|
Analysis Data Model
Clinical Data Acquisition Standards Harmonization Project
Clinical Data Interchange Standards Consortium
“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.”
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.
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.
A collection of observations with a topic-specific commonality about a subject.
Electronic case report form
|GGG||Global Governance Group|
National Cancer Institute
A recipient of medical treatment
Submission Data Standards. Also the name of the team that maintains the SDTM and SDTMIG.
Study Data Tabulation Model
SDTM Implementation Guide for Human Clinical Trials
|SDTMIG-PGx||SDTM Implementation Guide for Pharmacogenomics/Genetics|
A participant in a study
|TAUG||Therapeutic area user guide|
|TAUG-Nutrition||Therapeutic Area Data Standards User Guide for Nutritional Research|