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.
More Resources- Download the Slide Deck
- Read the Q&A below
Answers to Your Questions
We received over 60 follow-up questions from you. We’ve grouped them into the categories below and will answer them in our upcoming blog posts. As new posts are published, they will be linked below, so check back soon!
- Implementation Recommendations
- Submission Recommendations
- Validation with P21