Reportable Event FAQs
This page contains frequently asked questions about reportable events
Frequently Asked Questions about Reportable Events
Click below for FAQs related to reportable events.
The IRB will accept expedited reports when the investigator is unsure whether the event should be reported.
However, excessive unnecessary expedited reporting of events that do not suggest that subjects are being placed at greater risk than was previously known may impair the IRB’s ability to review and respond in a timely manner to actual situations where participants are being placed at greater risk.
The IRB encourages study teams to communicate the IRB’s policy to sponsors and use the IRB SOPs and IRB guidance as supporting documentation as necessary.Reportable Events IRB SOPs
No. Please enter the information requested into the form. Information in the form is used to prepare submissions for member review and complete data entry in the IRB’s system which is later documented in IRB minutes.
No. The IRB will not accept bulk AE submissions such as this, and your submission will be returned.
This will only be accepted when the amendment is directly related to reportable event. However, the IRB prefers that the reportable event be submitted as such, and a separate modification submission for the amendment. This is because the IRB reviews modifications and reportable events on different timelines to prioritize reviews appropriately, and the submissions require different IRB determinations.
The study team is responsible for recording and assessing all adverse events that occur locally in their research records. The assessment should include seriousness, expectedness, and relatedness. In the case of industry sponsored research, the Sponsor is often in the best position to determine expectedness. Per IRB SOP RI 801, an investigator is responsible for the accurate documentation, investigation and follow up of all adverse events that are possibly study related. Even if an event does not meet criteria for expedited IRB reporting it should still be documented in the study records. The IRB or other offices that conduct auditing could request these records for compliance reviews.IRB SOP RI 801 PSOM Guidance for Adverse Event (AE) Assessment
It should be the assessment from the PI where the event occurred.
To minimize risks to participants, adverse events require timely investigation and assessment. However, the IRB understands that this takes time to complete and sometimes an event is ongoing. In order to complete review of a reportable event, the IRB depends on the assessment from the sponsor as to whether an event is unanticipated/unexpected or related. Once the assessment from the sponsor is available, study teams should report the event to the IRB according to the timelines on the How to Submit a Reportable Event page. However, if the sponsor fails to provide an assessment in a timely manner (i.e., 90 days for non-fatal events and 30 days for fatal events) the IRB expects study teams to report to the IRB with the information available. The study team is then required to submit follow-up reports to the IRB with updated information in order for the review to be completed.
Provide as much information as possible. Once more information is received, submit a follow up report.
A SUSAR or “serious unexpected suspected adverse reaction” is not reportable to the IRB in most cases. A SUSAR may be considered a reportable event when there is reasonable possibility that the drug/investigational product caused the adverse event. For these reporting purposes, reasonable possibility means there is evidence to suggest a causal relationship between the drug/investigational product and the event.