*Termination or 5 days. Either the termination of IRB *Suspensions of research, approval or the suspension of Administrative Hold, FDA IRB approval requires the Clinical Hold, Enrollment prompt reporting by the Hold. Institutional Official to OHRP to the FDA for a clinical investigation that is FDA regulated, to the US DOJ when the research is federally supported or conducted by the US DOJ, to the NYC H+H when the research is conducted at Kings County Hospital, to an external institution when the research is conducted at an external site, and to the sponsor when applicable. 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 prompt (UPIRPO). reporting by the Institutional Official to OHRP, to the US *Must be reported to the full DOJ when the research is board if the event meets the federally supported or requirements to be reported conducted by the US DOJ, to within 5 days. the NYC H+H when the research is conducted at Kings See also SAE. County Hospital, to an external institution when the research is conducted at an external site, and to the sponsor when applicable. Unexpected AE (UAE). 5 days, if serious; otherwise, within 30 days. See also SAE and UPIRPO.
*Termination or *Suspensions of research, Administrative Hold, FDA Clinical Hold, Enrollment Hold. 5 days. Either the termination of IRB approval or the suspension of IRB approval requires the prompt reporting by the Institutional Official to OHRP to the FDA for a clinical investigation that is FDA regulated, to the US DOJ when the research is federally supported or conducted by the US DOJ, to the NYC H+H when the research is conducted at Kings County Hospital, to an external institution when the research is conducted at an external site, and to the sponsor when applicable. All Local Unanticipated Problems Involving Risks to Participants or Others (UPIRPO). *Must be reported to the full board if the event meets the requirements to be reported within 5 days. 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 prompt reporting by the Institutional Official to OHRP, to the US DOJ when the research is federally supported or conducted by the US DOJ, to the NYC H+H when the research is conducted at Kings County Hospital, to an external institution when the research is conducted at an external site, and to the sponsor when applicable. Unexpected AE (UAE). See also SAE and UPIRPO. 5 days, if serious; otherwise, within 30 days.
SUNYDMCIRB-01Policy01.19.2017FINAL-LOCKED.docx