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.

Reportable Event FAQs

Click for frequently asked questions about reportable events.

How to Submit a Reportable Event


Below are instructions for how to submit a reportable event.

  1. Download the Reportable Event form from the IRB Forms page.
  2. Complete the form. PI Signature on the form is NOT required when submitting in HSERA. The PI signs off electronically in HSERA.
  3. Sign in to HSERA.
  4. On the Blue left side Menu click “Create” under “My Submissions”
  5. On the next screen choose “Reportable Event”
  6. After clicking “Reportable Event” you will be brought to a screen with a list of all HSERA studies for which you are listed as either PI, Co-PI or Study Contact (note that Key Personnel cannot create submissions). Check to make sure your filter is clear. Then enter the protocol # you wish to submit a Reportable Event for and click “Filter”.
  7. When the appropriate study appears in the list, click the select button on the far right.
  8. After clicking the “Select” button you will be taken to the first page of the Reportable Event submission. Answer the screening questions in HSERA. Once this is complete, attach your Reportable Event form and supporting documents.
  9. Once the completed Reportable Event form and supplemental documentation are attached to the application, go to the bottom of the page and click “I accept” – your Reportable Event submission is now complete.
HSERA Download the Reportable Event Form
  1. Download the Reportable Event form from the IRB Forms page.
  2. After completing the submission form, have it signed by the PI, and scan it.
  3. Compile electronic versions of any other documents relevant to the deviation as well. Please do not send PHI to the IRB. Ensure any participant materials are redacted.
  4. Email the signed Reportable Event form and any other documents to the IRB PO box so that the closure submission may be reviewed electronically.
Download the Reportable Event Form IRB PO Box

IRB Review of Reportable Events


IRB staff will screen your report to determine if it is complete. If the reportable event form is not included or other 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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