Module 12 Presentations

26/01/2024

Analysis Data Model (ADaM)

 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).

The Organisation for Professionals in Regulatory Affairs

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Analysis Data Model (ADaM)

 Includes the Subject-Level Analysis Dataset (ADSL ) which describe subjects, analysis populations and treatment groups to which they belong or prognostic factors and includes one record per subject  Basic Data Structure (BDS) which may include one or more records per subject, per analysis parameter or per analysis time point.

The Organisation for Professionals in Regulatory Affairs

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