UCLA Office of the Human Research Protection Program, Institutional Review Board
POST-APPROVAL REPORTING REQUIREMENTS SUMMARY SHEET
WHAT, WHEN & HOW TO REPORT TO THE IRB (version 11.13.14)
This table summarizes which events or information should be reported and the reporting window. Submit in webIRB, if the study is approved in webIRB. If a
post-approval report warrants a change to the research (i.e. change in study status, informed consent form), submit an amendment with the report. See PostApproval Reporting Requirements on the OHRPP website.
IMPORTANT NOTE: Sponsors and/or other oversight entities reporting requirements may be different from the UCLA IRB
Type of Event
ADVERSE EVENTS (AE)
INTERNAL (on-site) AE that PI determines to be
 1) unexpected, 2) related or possibly related, and 3) places subjects or others at greater risk of harm than previously
known or recognized (i.e. serious) OR
 1) expected and 2) related but 3) indicates a higher frequency of occurrence or higher level of severity than was
previously known or recognized
EXTERNAL (off-site) AE that UCLA PI determines to be
 1) unexpected, 2) related or possibly related, and 3) places subjects or others at greater risk of harm than previously
known or recognized (i.e. serious)
Note: Submit event if all subjects have completed participation, if previously-enrolled subjects must be notified of
potential risk
For interventional studies only: Internal (on-site) death that PI determines to be 1) unexpected and 2) related or
possibly related
For interventional studies only: Internal (on-site) death that PI determines to be 1) expected and 2) related or possibly
related
External adverse event that UCLA PI determines does not meet the 10-working-day reporting criteria
OTHER TYPES of EVENTS or UPDATED STUDY SAFETY INFORMATION
Updated Investigator Brochure or Device Brochure
Audit or monitoring report, DSMB Report, or Interim Study Results
Other updated safety information or publication that addresses the risk or benefit of the research
Suspension, Hold or Termination of study activities
PROTOCOL VIOLATIONS, DEVIATIONS and INCIDENTS, including SUBJECT COMPLAINTS
Violation, deviation or incident that is 1) unexpected, 2) related or possibly related to the study and 3) places subjects
or others at greater risk of harm than previously known or recognized. See reporting form for examples
Emergent protocol deviation to eliminate apparent immediate hazard to subject
Violation, Deviation or Incident that the UCLA PI determines does not meet 10 or 3-day reporting requirements
When to Report
Within 10 working days
of UCLA PI awareness.
Within 10 working days
of UCLA PI awareness.
Within 3 working days
of UCLA PI awareness
At time of continuing
review
Reporting not required
Within 10 working days
of UCLA PI awareness
Within 3 working days
of UCLA PI awareness
Within 10 working days
of UCLA PI awareness
Within 3 working days of
event
Report at time of
continuing review