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2023 PRIM&R Annual Conference

Flexibility and Innovation in Research Oversight Processes

FDA Regulated Research

H15 - [IN-PERSON ONLY] Oversight Committee Interaction in Clinical Research Beyond the IRB

Wednesday, December 6, 2023
1:45 PM – 2:45 PM ET
Location: Room 148
Deep Dive Series Human Subjects Research Call for Session Proposal
This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

In this session, speakers will delve into the role and function of Data Monitoring Committees (DMCs), Data Safety Monitoring Boards (DSMBs), and Endpoint Adjudication Committees (EACs). These committees are increasing best practice to provide an independent, expert evaluation of clinical trial events and an unbiased adjudication to determine if certain clinical trial events have been met. This basic session will review what other oversight committees exist at big institutions, but for whom little is known.

Learning Objectives:

  • Define the basic FDA and European Medicines Agency guidelines governing when DMCs/DSMBs and EACs should be considered for clinical trials
  • Explain the role of DMCs/DSMBs and EACs and how their oversight is different than the IRB
  • Describe why independence of DMCs/DSMBs and EACs from the sponsor/Clinical Research Organization is critical to eliminating the perception of bias