How to Submit Reportable Events

A reportable event is an adverse event or other incident that has the potential to be classified by the IRB as an unanticipated problem posing risks to participants or others. Events that meet IRB’s reporting criteria outlined below have specific time frames as to when they should be submitted to the IRB. Review the guidance to determine if the event meets IRB’s reporting criteria and if it is reportable, the timeline for when the event should be reported to the IRB.

 

Incidents identified retrospectively that are unintentional actions or processes departing from the IRB approved study protocol, federal regulations, or institutional policies are deviations and should be reported as such. Please follow instructions on How to Submit a Deviation if your event meets this definition.

What is an unanticipated problem involving risks to subjects or others?

 

An unanticipated problem is any incident, experience, or outcome that meets all three of the following criteria listed below. Only the IRB can categorize an event as an unanticipated problem. It is the research team’s responsibility to submit reportable events for IRB assessment.

 

  • Is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  • Is related or possibly related to an individual’s participation in the research; AND
  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, social, economic, legal, or informational harm) than was previously known.

How to Determine if a Reportable Event Should Be Submitted to the IRB

 

Regardless of the seriousness of the event, an event is reportable to the IRB when it has been determined to be both:

  1. Probably or definitely related to participation in the research; and

  2. Unexpected in terms of nature, severity, or frequency

Events that are possibly related only need to be submitted to the IRB when the event suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, social, economic, legal, or informational harm) than was previously known. Generally, this means the risk benefit ratio may be unacceptable and revisions to study documents may be warranted.

Expedited Reporting Timelines

Non-Fatal Events

10 Business Days

Death (Fatal Event)

3 Business Days

Reporting at the Time of Continuing Review

 

All events meeting the reporting criteria outlined above should be summarized at continuing review in the progress report. Utilize the table below to determine if an event should be reported.

 

Additional Reportable Event Guidance

Supplemental Reportable Event Guidance

Click for supplemental guidance about reportable events and associated definitions that may help guide your submissions.

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Reportable Event FAQs

Click for frequently asked questions about reportable events.

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How to Submit a Reportable Event

 

All reportable events must be submitted in eIRB. Studies that were approved by the IRB via paper submissions (paper studies) must also submit reportable events via eIRB. All paper studies should have an eIRB record. Please see the “How to Submit- Initial Submissions” page for further information regarding paper studies. 

 

Steps to Submit in eIRB

  1. Sign into eIRB.
  2. Search and select the associated protocol for the reportable event.
  3. Utilizing the Panel Short Menu on the left, scroll down to find and select “Adverse Events”. 
  4. Select the “Add Adverse Event” button within the submission.
  5. Review the blue box instructions at the top of page.
  6. Complete all fields. Be sure to save your work by selecting the “Save/Save draft” blue button as the page does not automatically save. 
  7. Upload any event-related correspondence such as emails with the medical monitor or sponsor, etc. by utilizing the purple “Drop files here or click to choose” button.
  8. Adverse Events do not get routed to the PI for review and submission within eIRB. Therefore, by selecting the “Attestation by Person Submitting” box, the submitter is confirming that the principal investigator (PI) has reviewed this AE and all relevant information has been included in the submission.
  9. If ready to submit, click the blue “Send for Review” button. 

 

Review Adverse Event Submission Slides

IRB Review of Reportable Events

 

IRB staff will screen your report to determine if it is complete. If documentation is missing your submission may be returned or IRB personnel will email you to provide the additional information. IRB personnel may also ask questions about the event.

 

If the IRB determines that the event did not meet reporting criteria, the event will be acknowledged.

 

If the event meets the IRB’s reporting criteria, the IRB will review the report to determine whether may be an unanticipated problem. If so, the event will be referred for convened board review. Events that are determined to be unanticipated problems involving risks to participants or others will be reported to internal and/or external entities according to SOP CO 602.

 

In addition, the IRB may make additional determinations or recommendations based on the review, such as but not limited to: request for more information, modification of the protocol or consent, additional clinical follow up of participants, providing additional information to participants, more frequent continuing review, requiring re-consent of all participants, notifying external sites, administrative hold, suspension, or termination of the research.

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