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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) | ||
| CRO | Contract research organization | ||
| 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 | HL7 | Health Level 7 |
| 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 | ||
| WHODRUG | World Health Organization Drug Dictionary | ||
| XML | eXtensible Markup Language |
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