The following abbreviations and terms are used in this document. Additional definitions can be found in the individual sections of this document and in the CDISC Glossary, available at https://www.cdisc.org/standards/glossary.
ADaM | Analysis Data Model |
ADaMIG | ADaM Implementation Guide |
CDISC | Clinical Data Interchange Standards Consortium |
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. |
Domain | A collection of observations with a topic-specific commonality about a subject |
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. |
NCI EVS | National Cancer Institute (NCI) Enterprise Vocabulary Services |
NIH | National Institutes of Health |
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) |
Subject | A participant in a study |