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The following table lists some of the abbreviations and terms 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).

Language shown below is used throughout this section and should be interpreted as specified.

Metadataspec
NumLanguageInterpretation
1CRF
  • Refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
2Collection Fields
  • Refers to where data is collected in a CRF.
3Collection Variable
  • Refers to where data is stored in an electronic data capture (EDC) system.  
4Mechanisms for data collection
  • Refers collectively to different approaches used to control how data are collected including tick boxes, checkboxes, radio buttons, and drop-down lists. 
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)
CTCAECommon Terminology Criteria for Adverse Events
DatasetA collection of structured data in a single file
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(US) Food and Drug Administration
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.
MedDRAMedical Dictionary for Regulatory Activities
PROPatient-reported outcome
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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