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Session 7 Track 4: It’s All About the Data! From Case Report Forms to Datasets, What Does FDA Need to Approve your Submission?
Session Chair(s)
Stacy Tegan
Program Director
Transcelerate Biopharma, Inc., United States
Years of product development, intricate planning of study execution, patients serving as study participants – it all comes down to the data. Electronic submissions bring the journey of the data to life for reviewers. It starts with recording the data. Learn how to overcome challenges of incorporating Case Report Forms into “reviewer friendly" submissions while balancing the need for efficiency. Study data then has to be tabulated and analyzed. With the best practices to be shared in this session, publishing CDISC compliant datasets will no longer be an intimidating process. Once that data arrives at FDA, it must pass validation to make it to the reviewer. Learn about the new validation criteria put into effect in September 2021, common reasons for rejection, and tools to help avoid these errors. Once submitted, FDA must assure the quality and integrity of the data. Learn about CDER’s Bioresearch Monitoring (BIMO) program’s requirements for new marketing applications.
Learning Objective : - Decide which potential solutions to common Case Report Form challenges are best suited for their situation
- Explain the essentials of publishing CDISC-compliant study data for inclusion in an eCTD-compliant regulatory submission
- Assess whether study data passes FDA’s Technical Rejection Criteria
- Interpret CDER’s Bioresearch Monitoring (BIMO) requirements for new marketing applications
Speaker(s)
Let's Talk About Case Report Forms (CRFs)
Evan Richardson, RAC
Certara Synchrogenix, United States
Director, Regulatory Services
Publishing Datasets: What You Need to Know (and What You Don't Need to Know)
Mckenzie Orchowski, MS
Biologics Consulting, United States
Associate Director of Regulatory Operations
Study Data Technical Rejection Criteria
Heather Crandall, MA
FDA, United States
Business Informatics Specialist, OBI, OSP, CDER
CDER’s Bioresearch Monitoring (BIMO) Requirements for New Drug and Biologic Licensing Applications
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI
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