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Master Protocol Workshop
Session 4: Addressing Common Challenges—Clinicaltrials.gov Registration and IRB Reviews
Michelle Detry, PhD
- Director, Adaptive Trial Execution & Senior Statistical Scientist
- Berry Consultants LLC, United States
AnnCatherine M. Downing, PharmD
- Senior Research Advisor - Clinical
- Eli Lilly and Company, United States
Master Protocols may not fit the standard methods for trial registration or IRB review. This session will have presentations on the unique considerations for registering a Master Protocol on clinicaltrials.gov and submitting for IRB reviews. The registering and review of these innovative designs may require additional interactions to determine registration requirements or educational materials for IRBs unfamiliar with Master Protocols.
Learning Objective :
- Explain the standard approach for registering a trial on clinicaltrials.gov and how Master Protocols may differ
- Outline strategies for submissions to IRBs to facilitate an informed and timely review process for these innovative protocols
- Obtain suggestions for interacting with the clinicaltrials.gov and IRB teams and how the interactions and estimated timelines may be different from standard trials
Addressing Common Challenges: IRB Review
Heather Dobbins, PhD
- ClinicalTrials.gov Lead Results Analyst, NCBI/NLM
- National Institutes of Health (NIH), United States
Lindsay McNair, MD, MPH, MS
- Chief Medical Officer
- WIRB-Copernicus Group (WCG), United States