UAE, or UADE, as described Investigators are required to serious (SAE) or below. report the sponsor alarming, AND promptly “to any adverse effect that may unanticipated, AND reasonably be regarded as definitely, probably, or caused by, or probably caused possibly related to the by, the drug. If the adverse investigational agent. effect is alarming, the For more information, see . investigator shall report the adverse effect immediately’”. Consult with the Sponsor or FDA for additional guidance. The is not term “alarming” defined by the FDA, so it is up to the or PI’s Sponsor’s discretion on how to interpret this term. 24 hours, if serious. The PI or IRB may consult with Research related injury 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. 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
UAE, or UADE, as described below. serious (SAE) or alarming, AND unanticipated, AND definitely, probably, or possibly related to the investigational agent. For more information, see . Investigators are required to report promptly “to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately’”. Consult with the Sponsor or FDA for additional guidance. 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. 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
Guidance-ResearchProtocolTemplate12.15.2016.docx