Manual & Forms

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

Guidance Documents on Unanticipated Problem and Adverse Event Reporting

  1. 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.
  2. For FDA governed research, please note that the criteria of an unanticipated problem is slightly different.
    • Unexpected
    • Serious
    • 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).
  3. Serious Adverse Events are defined as follows:
    • Death
    • 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: