Suncoast, Phoenix, & Northern CA Chapters: Navigating Protocol Deviations - New Guidance
Event Description:
The FDA’s new draft guidance reshapes how sponsors, investigators, and sites define, triage, and report protocol deviations (PDs). This panel turns dense regulatory language into clear, workable practice. Through case-based discussion and step-by-step decision pathways, speakers will show how to distinguish “important” and major deviations from minor ones, align classification with risk to subjects and data integrity, and tighten documentation so submissions stand up to audit and inspection. We’ll map what’s changed from prior norms to what the draft now expects—who reports what, to whom, and by when—so your team can standardize processes without slowing study conduct.
Panelists: Glenda Guest and Meghana Rao
Moderator: Kaushal Shah
Learning Objectives:
- Apply FDA draft guidance definitions to distinguish between important major and minor protocol deviations.
- Analyze changes from prior practice to the new draft guidance for identifying, categorizing, and reporting PDs.
- Evaluate submission requirements for PDs, including timelines, reporting structures, and documentation standards.
Registration Information:
- Chapter Member: $0
- ACRP Member: $0
- Non-Member: $0
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
Event Contacts:
- Cem Murdun: suncoastchapteracrp@gmail.com
- Kaushal Shah: kaushal.p.shah@asu.edu
- Meghana Rao: meghana.rao@nccacrp.org
The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.
MS Teams Meeting