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ADaM | CDISC Analysis Dataset Model |
ADSL | (ADaM) Subject-level Analysis Dataset |
ATC | Anatomic Therapeutic Chemical (code; WHO) |
CDASH | Clinical Data Acquisition Standards Harmonization |
CDISC | Clinical Data Interchange Standards Consortium |
CRF | Case report form (sometimes case record form) |
CTCAE | Common Terminology Criteria for Adverse Events |
Dataset | A collection of structured data in a single file |
Define-XML | CDISC standard for transmitting metadata that describes any tabular dataset structure. |
Domain | A collection of observations with a topic-specific commonality |
eDT | Electronic data transfer |
FDA | (US) Food and Drug Administration |
HPHC | Harmful and Potentially Harmful Constituents |
ISO | International Organization for Standardization |
ISO 8601 | ISO character representation of dates, date/times, intervals, and durations of time. The SDTM uses the extended format. |
ISO 3166 | ISO codelist for representing countries; the Alpha-3 codelist uses 3-character codes. |
MedDRA | Medical Dictionary for Regulatory Activities |
PRO | Patient-reported outcome |
SAP | Statistical analysis plan |
SDTM | Study Data Tabulation Model |
SDTMIG-AP | Study Data Tabulation Model Implementation Guide: Associated Persons |
SDTMIG-MD | Study Data Tabulation Model Implementation Guide for Medical Devices |
SEND | Standard for Exchange of Non-Clinical Data |
SNOMED | Systematized Nomenclature of Medicine (a dictionary) |
SOC | System Organ Class |
TDM | Trial Design Model |
TIG | Tobacco Implementation Guide |
WHODRUG | World Health Organization Drug Dictionary |
XML | eXtensible Markup Language |
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