Reportable Event Guidance
This page provides supplemental guidance about reportable events and associated definitions to help guide your submissions.
Adverse Event Definitions
Below are adverse event definitions that research teams should be aware of and include in their research protocols for adverse event assessment.
Adverse Event
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.
Serious Adverse Event / Effect
When the participant outcome results in death; is life threatening; requires admission to the hospital; causes disability or permanent damage; causes a congenital anomaly or birth defect; (for medical devices) requires medical or surgical intervention to prevent permanent impairment or damage; OR is some other serious important medical event that may jeopardize the patient and may require treatment to prevent one of the other outcomes previously listed (e.g., allergic reaction requiring treatment in an ER, seizures/convulsions, development of drug dependence or drug abuse, suicide attempt, etc.)
Unanticipated Adverse Medical Device Effect
Any serious adverse effect (see above) 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 IDE application, or any other unanticipated serious problem associated with a device that relates to the adverse impact on the rights, safety, or welfare of participants.
Examples of Medical and Non-Medical Events
Not all reportable events are clinical adverse events. Below are examples of both medical and non-medical events that may be reportable to the IRB.
Medical
- Adverse drug reactions
- 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 temporarily associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research
Non-medical
- Complaint of a participant when the complaint indicates unexpected ricks, 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 such as:
- Post-marketing withdrawal or FDA ban of an agent used in a protocol due to safety concerns
- Premature closure of a study (e.g. due safety, lack of efficacy, feasibility, financial reasons, etc.)
Breakdown for Reportable Event Assessments
Below is a breakdown of assessments required for reportable events.
Relatedness
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.
Severity
An event is considered serious if it meets the criteria of a serious adverse event listed above.
Clinical adverse events are often graded from 1 to 5 (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death).
The IRB considers severity grades of 4 and 5 to be serious events. Grade 3 events are considered “severe or medically significant” and therefore, may also be serious events, as assessed by the investigator.
The IRB requires reporting of events regardless of their seriousness, but including the seriousness assessment in the report is useful for the IRB review.
Expectedness
An event is considered 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). An event can also be deemed unexpected if 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. An event can also be considered unexpected if 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. If the event 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 than it may be determined to be unexpected.