A summary of recent guidance updates is below. For more detailed information, please visit the following UCSF IRB website pages: adverse events and protocol violations & incidents.
ADVERSE EVENTS
Professor Emeritus and Parnassus IRB Chair Victor Reus, MD, has dedicated more than two decades to ensuring that UCSF meets its high standards for participant welfare, safety, and privacy.
Longtime IRB committee member and Mission Bay chair, Gordon Fung, MD, PhD, MPH, has taken on a role to lead a newly formed cardiology-focused panel that will support studies across a wide and growing range of cardiology sub-specialties.
The Continuing Review Form in iRIS has been updated to a new version. Please see the December 7th bulletin for a summary of changes to the form.
Which studies will be affected?
The Continuing Review Form in iRIS will be updated to a new version on Monday, December 18th. For guidance about continuing reviews, please visit the IRB’s Continuing Review page.
What are the main changes?
New:
Updated Post-Approval Event Forms
Tips for Optimal iRIS System Performance
IRB Limited Meeting Schedule: Impact on Studies Expiring in November, December, January
Updated Post-Approval Event Forms
New versions of the Adverse Event Reporting (AER) Form, Protocol Violation/Incident Report (PV/…