to the IRB as described in the unanticipated IRB approved protocol. (unexpected), AND would have implications The is not term “alarming” for the conduct of the defined by the FDA, so it is up study (e.g., requiring a to the or PI’s Sponsor’s significant and usually discretion on how to interpret safety-related, change in this term. the protocol such as revising An individual AE occurrence inclusion/exclusion ordinarily does not meet criteria or including a new these criteria because, as an monitoring requirement, isolated event, its implications informed consent, or for the study cannot be brochure). investigator’s 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 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 agent 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. Only a convened (full) board may confirm a determination of or “serious” “continuing” Determinations or “serious” non-compliance “continuing”
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). to the IRB as described in the IRB approved protocol. 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 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. Only a convened (full) board may confirm a determination of “serious” or “continuing” Determinations “serious” or “continuing” non-compliance
SUNYDMCIRB-01Policy01.19.2017FINAL-LOCKED.docx