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Required Reporting During Conduct of Study

During the conduct of human subject research, certain types of events/problems may occur that require prompt review by the IRB. The Reportable Problems or Events Policy provides detailed information about the types of 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 events/problems that do not require immediate reporting to the Wright State IRB but must be reported at time of continuing review.  

Please consult the policy (page 3) to determine whether an event that occurred during your study must be reported to the IRB and if needed, add, complete, and submit a Reportable Event form for your study in RSP Gateway. If the study also requires modification based on the event reported, an amendment can be submitted concurrently in RSP Gateway.

Examples of 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 a Reportable Event?

For a step-by-step guide for creating and submitting a reportable event submission in RSP Gateway, refer to the How to Submit Continuing Review, Amendment, Reportable Event, Study Closure and Miscellaneous Forms Guide (PDF).