Serious Adverse Event. 24 if in a Clinical an The term is not “alarming” internal AE meets the following defined by the FDA, so it is up An AE or SAE may also meet criteria: to the PI’s or Sponsor’s the definition of an UPIRPO, discretion on how to interpret UAE, or UADE, as described serious (or alarming) this term. below. unanticipated An individual AE occurrence (unexpected), AND ordinarily does not meet would have implications criteria because, as an isolated for the conduct of the event, its implications for the study (e.g., requiring a study cannot be understood. significant, and usually Reporting requirements to the safety-related, change in sponsor of AEs for clinical the protocol such as trials conducted under IND are revising stricter. Consult with the inclusion/exclusion sponsor or see criteria or including a new monitoring 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 Non-Compliance. 24 hours, if serious or Any employee or is 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 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 the medication or notice 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
Serious Adverse Event. An AE or SAE may also meet the definition of an UPIRPO, UAE, or UADE, as described below. 24 if in a Clinical an internal AE meets the following criteria: serious (or alarming) unanticipated (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). The term “alarming” is not defined by the FDA, so it is up to the PI’s or Sponsor’s discretion on how to interpret this term. An individual AE occurrence ordinarily does not meet 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 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 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 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
IRB-01HumanResearchProtectionsProgramPolicy03.30.2017Locked.docx