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The following table lists some of the terms and abbreviations used in this guide. 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).


ADaMCDISC Analysis Dataset Model
ADSL(ADaM) Subject-level Analysis Dataset
ATCAnatomic Therapeutic Chemical (code; WHO)
CDASHClinical Data Acquisition Standards Harmonization
CDISCClinical Data Interchange Standards Consortium
CRFCase report form (sometimes case record form). In this guide, CRF refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
CTCAECommon Terminology Criteria for Adverse Events
DatasetA collection of structured data in a single file
Data Collection Field(s)

Data elements that are commonly on a CRF.

Data Collection Variable(s)

Data elements stored in an electronic data capture (EDC) system.  

Define-XMLCDISC standard for transmitting metadata that describes any tabular dataset structure.
DomainA collection of observations with a topic-specific commonality
eDTElectronic data transfer
FDA-CTP(US) Food and Drug Administration Center for Tobacco Products
HPHCHarmful and Potentially Harmful Constituents
ISOInternational Organization for Standardization
ISO 8601ISO character representation of dates, date/times, intervals, and durations of time. The SDTM uses the extended format.
ISO 3166ISO codelist for representing countries; the Alpha-3 codelist uses 3-character codes.
Mechanisms for Data CollectionDifferent approaches used to control how data are collected including tick boxes, checkboxes, radio buttons, and drop-down lists. 
MedDRAMedical Dictionary for Regulatory Activities
ObservationAn observation refers to a discrete piece of information collected during a study, e.g., a vital sign measured (observed) for a specific subject at a specific time as part of a study. 
PROPatient-reported outcome
QRSQuestionnaires, Ratings, and Scales
SAPStatistical analysis plan
SDTMStudy Data Tabulation Model
SDTMIG-APStudy Data Tabulation Model Implementation Guide: Associated Persons
SDTMIG-MDStudy Data Tabulation Model Implementation Guide for Medical Devices
SENDStandard for Exchange of Non-Clinical Data
SNOMEDSystematized Nomenclature of Medicine (a dictionary)
SOCSystem Organ Class
TDMTrial Design Model
TIGTobacco Implementation Guide
WHODRUGWorld Health Organization Drug Dictionary
XMLeXtensible Markup Language

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