ADAM PROGRAMMING

ADaM defines dataset and metadata standards that support

• Efficient generation
• Replication
• Review of clinical trial statistical analyses
• Traceability among analysis results, Analysis data, and data represented in the Study Data Tabulation Model (SDTM)

As understood, ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions