All Reportable Event submissions require use of the most recent version of the Reportable Event Form. Please select the appropriate form for the type of event you are reporting:

What is a Reportable Event? How do I determine if an event should be submitted as a Reportable Event? When do I submit it?

A reportable event is an adverse event or incident that has the potential to be classified by the IRB as an unanticipated problem posing risks to participants or others. In general, an incident is determined to be a reportable event when it is both:

  1. probably or definitely related to participation in the research , AND
  2. unexpected in terms of nature, severity, or frequency

Events that meet these criteria must be submitted to the IRB within 10 business days of discovery. HOWEVER, if the event involved a death related to research participation, investigators should report within 3 calendar days.

If the event does not meet the reporting criteria above, please refer to the following table regarding whether the event is reportable to the IRB and if so, when it should be reported.

 

If you do not have enough information to complete the Reportable Event form within the required timeframe, you must still submit a Reportable Event form with the information that is available. You should indicate that a follow up report will be provided once additional information has been obtained. You should also reach out to the IRB for additional guidance in these situations.

To better understand the types of events that qualify for expedited reporting, please review the list of common types of reported events and descriptions of the criteria used to determine whether the event is reportable.

(1) Related and Unexpected Adverse Medical Events

Related

  • An event is considered "related to the research procedures" if the cause of the event is deemed probably or definitely related to the investigational product or a procedure that was performed for the purposes of the research.

Note: A SUSAR or "Serious Unexpected Suspected Adverse Reaction" is not always reportable to the IRB. 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.

Unexpected

An event is unexpected if: 

  • It is not reflected in the protocol-related documents (such as the IRB-approved research protocol, the investigator’s brochure/package insert, the device investigational plan, or the current IRB–approved informed consent document).
  • It is not accurately reflected in protocol related documents. In essence, an event would be unexpected if it is at a frequency or severity that has not previously been observed and described in the protocol-related documents.
  • It is mentioned in the investigator’s brochure/package insert as occurring within a class of drugs or devices, or as anticipated based on the pharmacological properties or design of the product, but, are not mentioned as being observed with the particular product under investigation

Unanticipated Adverse Medical Device Effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

(2) Non-Medical Events

The IRB also requires prompt reporting of the following events:

  • Post-marketing withdrawal of a drug, device, or biologic used in a research protocol due to safety concerns.
  • FDA ban of a drug, device, or biologic used in a research protocol due to safety concerns.
  • Complaint of a participant when the complaint indicates unexpected risks, or the complaint cannot be resolved by the research team
  • Breach of confidentiality
  • Incarceration of a participant when the research was not previously approved under Subpart C and the investigator believes it is in the best interest of the subject to remain on the study
  • Premature closure of a study (e.g., due safety, lack of efficacy, feasibility, financial reasons, etc.)

 

What if I am not sure if an event meets the Reportable Event Criteria? What should I do if I determine that an event does not meet the definition of a Reportable Event?

What should I do if I am not sure if an event meets the criteria for a Reportable Event?

The IRB will accept expedited reports when the investigator is unsure whether the event should be reported. However, unnecessary expedited reporting of events that do not suggest that subjects are being placed at greater risk may impair the IRB’s ability to review and respond in a timely manner to actual situations where subjects are being placed at greater risk.

The IRB will not acknowledge safety reports or bulk AE submissions that do not meet the criteria outlined above. These submissions will be returned.

The IRB encourages study teams to communicate the IRB’s policy to sponsors and should use this guidance as supporting documentation as necessary.

What should I do if I determine that an event does not meet the definition of a Reportable Event

All study teams should record and assess all internal adverse events in their research records when they occur. The assessment should include seriousness, expectedness, and relatedness. 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.

Refer to the table above to determine what events are reportable to the IRB. Note that some events are not reportable. Please see the How to Submit Continuing Review page for additional guidance about summarizing adverse events in your continuing review submission.

How does the IRB review Reportable Events? What types of determinations are made?

IRB staff will review your report to determine if it is complete. IRB personnel may ask you to provide additional information regarding the event.

  • If the IRB determines that the event did not meet the IRB’s definition of a reportable event, the IRB will issue an acknowledgment of the report.
  • If the event meets the IRB’s definition of a reportable event, the IRB will review the report to determine if it meets the definition of an unanticipated problem involving risk to participants or others. This may include review at a convened IRB meeting. 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.