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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 |
|---|---|
CRFs | Case Report Forms. |
| EVS | NCI Enterprise Vocabulary Services. |
| SMEs | Subject Matter Experts. |
TAPSC | CFAST Therapeutic Area Program Steering Committee. |
| TLC | Technical Leadership Committee. |
| 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. |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
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