Guidance Updates: Reporting Adverse Events, Protocol Violations, and Investigator’s Brochures to the UCSF IRB

April 04, 2024

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

1. To better align with FDA reporting guidance, the UCSF IRB has updated the post-approval reporting requirements for adverse events occurring at a site where UCSF is the IRB. 

Previous AE Reporting Criteria

New (April 1, 2024) AE Reporting Criteria

1. Definitely, probably or possibly related AND

2. Serious or unexpected

 

1. Definitely, probably or possibly related AND

2. Is EITHER:

Serious and unexpected

OR

Serious and more frequent or severe than expected

 

2. The website now includes information about the importance of documenting non-reportable adverse events on an AE study log. You do not need to report these to the IRB, but proper documentation of all AE’s is necessary for monitoring and auditing purposes.

PROTOCOL VIOLATIONS

1. The IRB has clarified reporting criteria by adding the highlighted criterion (below) for reporting of major violations. Violations not meeting the following criteria should not be reported (exception: see #2 below).

Protocol Violation Reporting Criteria

HRPP criteria for defining major violations include any of the following:

  • The violation has harmed, or posed a significant or substantive risk of harm, to the research participant
  • The violation resulted in a change to the participant’s clinical or emotional condition or status
  • The violation has damaged the scientific completeness or soundness of the data collected for the study
  • The violation is evidence of willful or knowing misconduct on the part of the investigator(s)
  • The violation involves serious or continuing noncompliance with federal, state or local regulations
  • The UCSF IRB has determined the incident requires reporting

2. If the study sponsor, funding agency or CRO requires reporting to the IRB for a protocol violation that does not meet the above reporting criteria, please use the iRIS Reporting Form to report the incident instead of the Protocol Violation/Incident Form.

3. The UCSF Privacy Office should be contacted for studies relying on an external (non-UCSF) IRB if the incident is privacy related. A report to the UCSF IRB is not required if UCSF is not the IRB of record.

INVESTIGATOR’S BROCHURES

1. New versions of an Investigator’s Brochure must be reported on the Modification Form. Previously, these were reported on either the iRIS Reporting Form or the Modification Form.

2. The IRB no longer requires that IBs are reported within 10 working days. Instead, please submit them only after the Principal Investigator has completed an assessment of any changes to the risk/benefit ratio of the study. On the Modification Form, please indicate the date the Investigator’s Brochure was received by the study team.