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List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.
| Term | Definition |
|---|---|
| TA | Therapeutic Area |
| TAPSC | Therapeutic Area Standards Program Steering Committee |
CRFs | Case Report Forms. |
| EVS | NCI Enterprise Vocabulary Services. |
| SMEs | Subject Matter Experts. |
TAPSC | CFAST Therapeutic Area Program Steering Committee. |
| TLC | The Technical Leadership Committee 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, an 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). |
| ADaM SME | Analysis Data Model Subject Matter Expert. |
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