How to Report to the IRB

Follow the instructions below to report:

  • A minor or major protocol deviation
  • An unanticipated Problem (including serious adverse events)

Protocol Deviations

Step 1: Click HRPP Policies and Procedures to review guidance on major and minor protocol deviations.
Minor Deviation
Step 2: When minor deviations occur, record them in the Protocol Deviation Log located on our IRB Forms page
Step 3: When the study is due for Continuing Review:

  • Submit the Protocol Deviation Log along with the Application for Continuing Review
  • Describe minor protocol deviation(s) in the appropriate section of the Progress Report Form
Step 4: Follow procedures for submitting progress reports to the IRB. Click here for guidance.
Major Deviation
Step 2: Complete the following form: Reportable Event Form located on our IRB Forms page
Step 3: Submit completed Reportable Event Form to the IRB.
Reports of protocol deviations should be submitted to the sponsor according to the sponsor’s protocol.
!! Major protocol deviations must be reported to the IRB within ten (10) working days of discovery !!

Unanticipated Problems (including Serious Adverse Events)

Step 1: Review HRPP Policies and Procedures on Serious Adverse Events and Unanticipated Problems regarding when these should be reported.
Step 2: Complete the following form: Reportable Event Form located on our IRB Forms page
NOTE:   Please answer ALL questions. Do not leave any blank areas. Any questions that are not applicable should be marked “N/A.”
Step 3: Submit completed Reportable Event Form and all relevant documents (e.g., progress notes, lab results, consults, discharge summaries, death certificates, appropriate follow-up and outcome documentation, etc.) to the IRB.
NOTE: All serious adverse events that that qualify as an unanticipated problem involving risk to subjects or others, during a study or in a post-study period of reasonable duration (i.e. during follow-up), MUST be reported to the IRB and the study sponsor, as appropriate, within 5 business days of occurrence or knowledge of event by the investigator.