Enrollment Hold. on hold, and all such actions require reporting to OHRP, and to FDA and sponsor when applicable, by the IO. All Local Unanticipated 5 days, if serious; otherwise, If the IRB concurs or Problems Involving Risks to within 30 days determines that an event is an Participants or Others UPIRPO, it requires reporting (UPIRPO). by the IO to the OHRP, and to FDA when applicable. See also SAE. Unexpected AE (UAE). 5 days, if serious; otherwise, If the IRB concurs or within 30 days determines that this event is See also SAE and UPIRPO. also an UPIRPO, it requires reporting by the IO to the OHRP, and to FDA when applicable. Audit or Monitoring 5 days if findings identify Activities. apparent serious or continuing noncompliance; otherwise at Must be reported to the full continuing review or study board if the event meets the closure. requirements to be reported within 5 days. Unanticipated Adverse As soon as possible, but no Report to sponsor within 10 Device Effect (UADE). later than 10 days days. If the IRB concurs or See also SAE and UPIRPO. determines that this event is also an UPIRPO, it requires reporting by the IO to the OHRP, and to FDA when applicable. Interim Analysis Reports, Submit to the IRB within 30 Data Monitoring Committee days of notice (DMC) Data and Safety Monitoring Board (DSMB) reports. External reportable events N/A Report to IRB, if required by (e.g., those that occurred the Sponsor, but no later than with participants that were the time of continuing review enrolled outside of the local during the approval period for which the event occurred.
Enrollment Hold. on hold, and all such actions require reporting to OHRP, and to FDA and sponsor when applicable, by the IO. All Local Unanticipated Problems Involving Risks to Participants or Others (UPIRPO). See also SAE. 5 days, if serious; otherwise, within 30 days If the IRB concurs or determines that an event is an UPIRPO, it requires reporting by the IO to the OHRP, and to FDA when applicable. Unexpected AE (UAE). See also SAE and UPIRPO. 5 days, if serious; otherwise, within 30 days If the IRB concurs or determines that this event is also an UPIRPO, it requires reporting by the IO to the OHRP, and to FDA when applicable. Audit or Monitoring Activities. Must be reported to the full board if the event meets the requirements to be reported within 5 days. 5 days if findings identify apparent serious or continuing noncompliance; otherwise at continuing review or study closure. Unanticipated Adverse Device Effect (UADE). See also SAE and UPIRPO. As soon as possible, but no later than 10 days Report to sponsor within 10 days. If the IRB concurs or determines that this event is also an UPIRPO, it requires reporting by the IO to the OHRP, and to FDA when applicable. Interim Analysis Reports, Data Monitoring Committee (DMC) Data and Safety Monitoring Board (DSMB) reports. Submit to the IRB within 30 days of notice External reportable events (e.g., those that occurred with participants that were enrolled outside of the local N/A Report to IRB, if required by the Sponsor, but no later than the time of continuing review during the approval period for which the event occurred.