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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).
- Both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
- Data elements that are commonly on the CRF.
- Refers collectively to
| 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). In this guide, CRF refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified. |
| CTCAE | Common Terminology Criteria for Adverse Events |
| Dataset | A 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-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. |
| Mechanisms for Data Collection | Different approaches used to control how data are collected including tick boxes, checkboxes, radio buttons, and drop-down lists. |
| 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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