How the CDISC ADaM team is working to support the safety and efficacy of FDA review
View Presentation View Presentation
*Nate Freimark, Biometrics Operations Standsrs Group. Theorem Clinical Research 


It is stated in the Analysis Data Model, version 2.1 in the Introduction/Purpose Section 1 that “The Analysis Data Model supports efficient generation, replication, and review of analysis results.” Enabling reviewers to understand how results were created and how to reproduce them based on the submitted data is one of the key drivers behind the blueprint of the ADaM model. The various sections of the ADaM model will be reviewed to show how each contributes to this ideal. The data and metadata components will be described and how each facilitates its intended purpose will be illustrated through definitions and examples.