West Virginia Chapter: Oops in the Ops: Catching, Categorizing, and Reporting Protocol Deviations (ACRP 2026 Conference Replay)
This event will be presenting a replay sessions from the ACRP Conference Library
Event Description:
Protocol deviations, if not properly identified and addressed, can jeopardize participant safety, data integrity, and trial credibility. The FDA’s December 2024 draft guidance on "Protocol Deviations for Clinical Investigations" introduces clearer expectations around assessing, categorizing, and reporting deviations, especially those deemed “important.”
This session will provide attendees with a practical framework to align their practices with the evolving regulatory landscape. Through real-world case scenarios and an interactive exercise, participants will learn how to evaluate deviations using a risk-based approach and strengthen communication with institutional review boards and sponsors. We will also analyze emerging tools, including automation and artificial intelligence, that support proactive deviation detection and inspection readiness.
Speakers:
- Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training
- Meghana Rao, Sr. Manager, Clinical Trial Lead, Olema Oncology
- Kaushal Shah, PhD, Director & Clinical Associate Professor, Clinical Research Management & Regulatory Science Programs, Arizona State University
Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hour): $0
- ACRP Member (registration only): $0
- ACRP Member (registration + contact hour): $15
- Non-Member (registration only): $0
- Non-Member (registration + contact hour): $75
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To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available.