When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. If you missed it, you can watch the video recording (above) and download the slide deck. 

Answers to Your Questions

We have received over 200 follow-up questions from you. That's a lot of questions! So we decided to group them into the categories below and answer them in our upcoming blog posts. As new posts are published, they will be linked below, so check back soon. 

1. EPOCH Implementation
2. Screen Failures
3. Duplicate Records
4. Controlled Terminology
5. Traceablity Rules
6. Trial Summary
7. WHODrug Validation
8. Validation Configuration / Define.xml Validation
9. Define.xml Implementation