In the regulatory review process, it's critical to have analysis data that comply with the CDISC ADaM standard. Both the FDA and PMDA require ADaM data, and as they begin reviews, they start with ADaM data validation. ADaM data 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.
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- Read the Q&A below
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