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| Term | Definition |
|---|---|
| TA | Therapeutic Area. |
| TAPSC | Therapeutic Area Standards Program Steering Committee. |
CRFs | Case Report Forms. |
| EVS | National Cancer Institue (NCI) Enterprise Vocabulary Services. |
| SMEs | Subject Matter Experts. |
| 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). |
| SME | Subject Matter Expert. |
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