Required Reporting During Conduct of Study

During the conduct of human subject research, investigators sometimes receive information that has a direct impact on the research study, and/or certain types of incidents/events/problems may occur that require prompt review by the IRB. The Incidents, Reportable Problems or Events Policy provides detailed information about the types of incidents/events/problems that must be submitted to the Wright State IRB within 10 business days (see below for examples of events that require prompt reporting). The policy also defines incidents/events/problems that do not require immediate reporting to the Wright State IRB but must be reported at time of renewal/continuing review.  

Please consult the policy to determine whether an incident/event that occurred during your study must be reported to the IRB and if needed, add, complete, and submit a form in Cayuse Human Ethics. If the study also requires changes based on the event reported, an modification can be submitted concurrently in Cayuse.

Types of Reportable Incidents: 

  • Unanticipated Problem or Adverse Event
    • Internal or External
    • Internal Subject Death even if anticipated if occurs within 30 days of study procedures
    • Adverse Device Effects
  • Protocol deviation/violation
    • Alteration to approved study procedures
    • Change in research to eliminate an immediate hazard to a subject
  • Report(s) to or from oversight entity
  • Report of study lapse
    • Accident/incident
    • Data Breach
  • Self Report of Noncompliance
  • Subject Complaint
  • Subject Incarceration
  • Subject Withdrawal
  • Pertinent publication/public announcement
  • Notification of audit/inspection/inquiry


Examples of incidents, problems or events that must be promptly reported to IRB:

  • A subject event during the research that is serious (death or hospitalization), unexpected (not listed as risk in consent) and related or possibly related to the study
  • Subject death in a “greater than minimal risk” study even if expected if it occurs within 30 days of study-related research procedure
  • Major deviation from the approved IRB protocol, such as:
    • Failure to obtain written consent prior to a subject’s study participation
    • Recruiting subjects under the age of 18 when not previously approved by IRB
    • Subject received a dose of a study drug that is not consistent with the protocol
  • Breach of confidentiality for research involving protected health information (PHI), such as loss of a laptop containing identifiable study data
  • Incarceration of an active study subject for a study that is not approved to involve prisoners
  • Subject complaint that cannot be fully resolved by the study team
  • FDA or sponsor audit (does not include regular sponsor monitoring)


How do I submit an Incident or Reportable Event?

For a step-by-step guide for creating and submitting a reportable event submission in Cayuse, refer to the PDF icon Cayuse Investigators Guide. The Information regarding Incident submissions start on slide 65.