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 The FDA’s December 2024 draft guidance on "Protocol Deviations for Clinical Investigations" introduces clearer expectations around assessing, categorizing, and reporting deviations, especially those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. Designed for clinical operations teams, site staff, and quality assurance professionals, this session combines compliance essentials with forward-looking strategies.
CEU: 1.00 ACRP
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