All Reportable Event submissions require use of the most recent version of the Reportable Event Form. As of 6.18.19 the IRB has only one reportable event form for all events. Click Here to download the Reportable Event Form
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. An incident is determined to be reportable to the IRB when it is both:
- probably or definitely related to participation in the research
- 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 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 still must submit a Reportable Event Form with the information 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.
Please review the definitions and examples below to better understand the criteria used to determine whether an event is reportable.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research or the use of a medical product, whether or not considered related to the subject’s participation in the research.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
- 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: Possibly related events do not require expedited reporting UNLESS the event suggests that the research places subjects at greater risk than was previously known or recognized (i.e., changes to the study conduct and/or documents are required to mitigate risk and/or participants’ willingness to participate may be adversely impacted). If the event suggests that the research places subjects at greater risk than was previously known or recognized, the event may be an unanticipated problem involving risks to subjects or others and requires assessment by the IRB.
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.
- It is not an expected natural progression of any underlying disease, disorder, or condition, and not expected per the subject’s predisposing risk factor profile for the adverse event.
Seriousness / Severity
A serious adverse event is when the participant outcome is:
- Life-threatening: The participant was or was suspected to be at substantial risk of dying at the time of the adverse event, or the research procedures (including drugs or devices) might have resulted in the death of the patient.
- Hospitalization (initial or prolonged): Admission to the hospital or prolongation of hospitalization was a result of the adverse event.
- Disability or Permanent Damage: Resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities and/or quality of life.
- Congenital Anomaly/Birth Defect: Suspected that exposure to the research procedures (including drugs or devices) prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
- Research involving Medical Devices - Required Intervention to Prevent Permanent Impairment or Damage: Medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.
- Other Serious (Important Medical Events): The event does not fit the other outcomes above, but the event may jeopardize the patient and may require treatment (medical or psychological intervention) to prevent one of the other outcomes above. Examples include: allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders), seizures/convulsions that do not result in hospitalization, the development of drug dependence or drug abuse, suicide attempt, psychotic break, etc.
- Other events that change the risk/benefit ratio of the study or suggest that the research is placing subjects or others at greater risk of physical or psychological harm than was previously known or recognized.
Subjects or Others at Greater Risk
OHRP notes that “adverse events that are... serious always suggest that the research places subjects or others at greater risk.” However, non-serious adverse events may also qualify. If the event may change a participant's willingness to participate AND/OR warrants substantive changes in the research protocol, informed consent, or other corrective actions it likely meets this criteria.
Applicable to: Participants OR Others
Types of Risk: physical, psychological, economic, or social harms
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.
Examples of Medical and Non-Medical Events
Any injury, illness, disease, or death, incurred by the subject while enrolled on a research protocol. Medical adverse events may include (but are not limited to) the following:
- Adverse drug reactions,
- Any other subject illness or injury that may be related to the research procedures (i.e. pain, nausea, or other discomforts such as psychological or emotional harm),
- Abnormal physical exam or laboratory finding, symptom, or disease temporally associated with the subject's participation in the research, whether or not considered related to the subject’s participation in the research;
Note: 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.
The IRB also requires prompt reporting of the following events:
- Complaint of a participant when the complaint indicates unexpected risks, or the complaint cannot be resolved by the research team
- 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
- Any other event that may present economic or social harm to a subject or may adversely affect the subject’s well-being
New information that may change a participant's willingness to participate, which includes:
- 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.
- Premature closure of a study (e.g., due safety, lack of efficacy, feasibility, financial reasons, etc.)
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.
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.