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
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, during the ongoing review process, that the PI contact the currently enrolled research participants to inform them of the new information. If the change to the risk/benefits ratio is adverse, the informed consent should be amended and submitted to IRB for approval. The informed consent should be updated and the IRB may require that the currently enrolled research participants be re-consented, acknowledging receipt of this new information and for affirming their continued participation. Changes Initiated to Eliminate an Apparent Immediate Hazard days. 5 days Include an amendment, to propose any additional or permanent changes. Expanded Access, Emergency Use, or Compassionate Use of an Unapproved Drug, Unapproved Biologic, or Unapproved Device. Notify IRB as soon as possible. Notify the IRB within 5 days of drug administration or device use Requires approval of the Department Chair and Medical Director before administration. Protocol Deviations (including modifications made without IRB approval), Violations, or Complaints. *Must be reported to the full if the event meets the requirements to be reported within 5 days. 5 days, if it adversely affects: the rights, safety, or welfare of the research participant; or the research participant’s willingness to continue participation; or the integrity of the research data, including information security requirements. Include an amendment, to propose any additional or permanent changes, as a corrective action. Any complaints involving translations or interpretations must also be reported to patient relations.