(unexpected), AND these criteria because, as an isolated event, its implications would have implications for for the study cannot be the conduct of the study (e.g., understood. requiring a significant, and usually safety-related, Reporting requirements to the change in the protocol such sponsor of AEs for clinical as revising trials conducted under IND are inclusion/exclusion criteria or stricter. Consult with the including a new monitoring sponsor or see requirement, informed consent, or investigator’s brochure). *Research related injury 24 hours, if serious. The PI or IRB may consult with involving provision of general counsel regarding Report within the current healthcare. recommended action. approval period, if minor. *Apparent 24 hours, if serious or Any employee or agent is Non-Compliance. continuing expected to report any apparent non-compliance to Report within the current the IRB or to the Compliance approval period, if minor (e.g., Hot Line at 877-349-SUNY protocol deviation) (7869) or via the . You may make an anonymous report using the web based system, if desired. New Information that 24 hours if serious; otherwise Indicates a Change to the within 5 days Risks or Potential Benefits of the Project. Significant New Finding. If serious, notify the IRB within During the course of research, 24 hours; otherwise, submit to significant new knowledge or the IRB within 30 days of findings about the medication notice or test article and/or the condition under study may develop. The PI should report any significant new findings to the IRB and the IRB will review them with regard to the impact on the research participants’ rights and welfare. Since the new knowledge or findings may affect the risks or benefits to research participants’ willingness to continue in the research, the IRB may require,
(unexpected), AND would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure). these criteria because, as an isolated event, its implications for the study cannot be understood. Reporting requirements to the sponsor of AEs for clinical trials conducted under IND are stricter. Consult with the sponsor or see *Research related injury involving provision of healthcare. 24 hours, if serious. Report within the current approval period, if minor. The PI or IRB may consult with general counsel regarding recommended action. *Apparent Non-Compliance. 24 hours, if serious or continuing Report within the current approval period, if minor (e.g., protocol deviation) Any employee or agent is expected to report any apparent non-compliance to the IRB or to the Compliance Hot Line at 877-349-SUNY (7869) or via the . You may make an anonymous report using the web based system, if desired. New Information that Indicates a Change to the Risks or Potential Benefits of the Project. 24 hours if serious; otherwise within 5 days Significant New Finding. If serious, notify the IRB within 24 hours; otherwise, submit to the IRB within 30 days of notice During the course of research, significant new knowledge or findings about the medication or test article and/or the condition under study may develop. The PI should report any significant new findings to the IRB and the IRB will review them with regard to the impact on the research participants’ rights and welfare. Since the new knowledge or findings may affect the risks or benefits to research participants’ willingness to continue in the research, the IRB may require,
GuidanceReportableEvents03.30.2017_000.docx