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| Term | Definition |
|---|---|
| TA | Therapeutic Area. The TA is an area of medical practice that encompasses groupings of specific diseases and/or disorders generally treated by a specific medical specialty, such as oncology, cardiovascular, neurology or hematology. |
| TAPSC | Therapeutic Area Standards Program Steering Committee. |
CRFs | Case Report Forms. CRFs used to capture clinical trial data rely on linkages between and among concepts. CRFs also frequently contain logic, such as which values are allowed for a given field, when one field is a value calculated from other fields, and when some fields are not relevant based on an answer to another field. |
| EVS | National Cancer Institute (NCI) Enterprise Vocabulary Services. EVS provides terminology content, tools, and services to meet the needs of NCI and the biomedical research community. |
| SMEs | Subject Matter Experts. SME is a person who possesses a deep understanding of a particular subject. |
| TLC | Technical Leadership Committee. The TLC is made up of Foundational Standards Team Leads. This committee discusses issues pertaining to the Foundational Standards. The TLC also develops the agenda for CDISC IntraChanges and typically leads sessions during these events. |
| ADaM | Analysis Data Model. ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM). ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). |
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