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 Concept | A 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 |