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Federal regulations require the organization to ensure prompt reporting of "any unanticipated problems involving risk to subjects or others" (UPIRTSO) to the IRB, regulatory agencies, and institutional officials." The IRB makes the determination of whether the problem meets the definition of a UPIRTSO.

PI Responsibilities
  • Reports adverse events and UPIRTSOs to the IRB according to IRB policies and procedures, sponsors, and appropriate Federal agencies as required
  • Reviews and approves IRB applications, amendments and adverse events prior to their submission to the IRB, as documented by their signature on the IRB application. Submits applicable reports in a timely manner or according to published deadlines



direct edit