analyses dataset
- Guideline or reference source
- FDASDS Study Data Specifications
- Definition
- Analysis datasets are created to support results presented in study reports, the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE) and to support other analyses that enable a thorough regulatory review. Analysis datasets contain both raw and derived data.
- Broader Term
- data set
- Related Term
- data definition file
- data listing
- data tabulations
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