Integrating Expert Opinions: Why Your Clinical Trial Needs an EAC
Evaluating clinical trial endpoints is often complex and requires a fair bit of expert judgement.
Independent endpoint adjudication committees (EACs) provide necessary support to sponsors and contract research organizations (CROs), focusing on evaluating specific medical events and outcomes in clinical trials.
This webinar outlines the independent EAC’s role and function, from charter creation through study closeout.
Learning Objectives:
- Define the basic Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines governing when EACs should be considered for clinical trials
- Outline key takeaways to prepare your research program for engaging collaboratively with an independent EAC
- Explain the role of the EAC and how their oversight is different than the data monitoring committee (DMC) and the institutional review board (IRB)
- Describe the difference between an EAC and the sponsor’s medical monitor
Presented By
James Riddle
MCSE, CIP, CPIA, CRQM
Vice President, Research Services & Strategic Consulting
Advarra
Barbara Schneider
PhD, MBA
Executive Director, Biostatistical Services
Advarra
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DATE: February 17, 2022
Time: 1 pm ET | 10 am PT
Duration: 1 hour