Event Type (*= Requires Full Board Review or SAE Subcommittee Review) See definitions in IRB guidance documents for a description of each event. Deadline from when the investigator first learns of an internal event for reporting to IRB for an internal event (e.g., those that occurred with within the DMC IRB’s jurisdiction) Comments *Government inspection (or audit) Report findings within 24 hours, if any serious or continuing non-compliance was found or proposed; otherwise within 5 days. The study team should alert the IRB when the inspection is scheduled or if an inspector arrives unannounced, so the IRB may help as needed. *Privacy Violation (or Breach). Immediately report this to IRB and Privacy Officer *Information (Data) Security Violation (or Breach). Immediately report this to IRB and Data Security Officer Incarceration of a research participant. Immediately, if participant is actively incarcerated; otherwise within 5 days Any FDA Actions or changes to a HUD. Immediate Serious Adverse Event. An AE or SAE may also meet the definition of an UPIRPO, UAE, or UADE, as described below. 24 hours, if an internal AE in a Clinical Trial meets the following criteria: serious (or alarming) AND unanticipated 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
(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,
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 Chair 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. May require IND or IDE from FDA. Protocol Deviations (including minor modifications made without IRB approval), Violations, or Complaints. *Must be reported to the full board 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. Otherwise report to IRB before continuing review or project closure. 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. *Termination or *Suspensions of research, Administrative Hold, FDA 5 days The IRB may also elect to terminate or suspend IRB approval or place enrollment
(e.g., those that occurred with participants that were enrolled outside of the local site of the IRB jurisdiction). the Sponsor, but no later than the time of continuing review during the approval period for which the event occurred. Sponsored required reporting. N/A Deadline is determined by sponsor Kevin L. Nellis, MS, CIP Original Issue Date: 03.16.2017 Revision Date: N/A Date Reviewed & Approved Revision Required Responsible Staff Name and Title Yes No 03.16.2017 X Kevin L. Nellis, MS, CIP, Executive Director, Human Research Protections and Quality Improvement 03.30.2017 X -Updated IRB reporting requirements for SAE. Kevin L. Nellis, MS, CIP, Executive Director, Human Research Protections and Quality Improvement