What you need to know when validating your CDISC ADAM datasets
During the regulatory review process, it’s critical to have analysis data that complies with CDISC’s ADaM standard. Both the FDA and PMDA require CDISC ADaM datasets, and as they begin reviews, they start with ADaM data validation. CDISC ADaM datasets help these agencies understand the analyses performed and reproduce the results for further validation.
In this webinar, Trevor Mankus covers the more commonly occurring validation rules and some potential reasons why they fired.