Unanticipated Problem and Adverse Event Reporting
Unanticipated problems, adverse events (AE) and serious adverse events (SAE) must be reported to the IRB in a prompt manner by investigators. The IRB has established definitions, a reporting process, and policy related to unanticipated problems and adverse events that is available on the policies page.
Unanticipated Problem and Adverse Event Reporting Flowcharts
- Adverse Event Reporting Flowchart
- Unanticipated Problem Reporting Flowchart
- FDA Adverse Event Reporting Flowchart
Guidance Documents on Unanticipated Problem and Adverse Event Reporting
- Unanticipated Problems (non FDA research) are considered to include any incident, experience, or outcome that meets all of the following criteria:
- Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related outcomes, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
- For FDA governed research, please note that the criteria of an unanticipated problem is slightly different.
- Would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure).
- Serious Adverse Events are defined as follows:
- Congenital Anomaly/Birth Defect
- Hospitalization Required or Prolongation of a Hospitalization
- Life Threatening Event
- Significant or Persistent Disability/Incapacity
Unanticipated problems and adverse events must be reported to the IRB within 5 working days. Serious adverse events must be reported to the IRB within 24 hours.
Unanticipated problems, adverse events, and serious adverse events are to be reported using the: