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Sponsor/CRO IND Safety Report Submission Guidelines * The term "IND Safety Report" is being used here to represent all types of external adverse events reports, including, but not limited to, IND Safety Reports, Data Safety Monitoring Board Reports, and FDA Safety Alert Letters. 1. GENERAL INFORMATION One of the primary responsibilities of an Institutional Review Board (IRB) is to monitor the safety and welfare of participants at research sites that are acting under its jurisdiction. In recent years, especially in the case of larger multi-center studies, the reporting of adverse events that are external to an IRB's jurisdiction (e.g., IND Safety Reports) has begun to outweigh the reporting of internal adverse events (i.e., those taking place at the sites acting under the IRB's jurisdiction). While the Sponsor is required to collect all IND Safety Reports for a given protocol, only a small subset of those reports should be submitted to the IRB. The only IND Safety Reports that need to be submitted to the IRB are those that describe "unanticipated problems involving risks to the subject" [21 CFR 56.108(b)(1)], 21 CFR 312.32(c)] and those for device studies. The excess reporting of IND Safety Reports to the IRB has the potential to limit the IRB's ability to adequately monitor the safety and welfare of participants at sites that are acting under its jurisdiction. The Office for Human Research Protections (OHRP) has composed a guidance for Sponsors, Principal Investigators and IRBs that can be used to determine which IND Safety Reports need to be submitted to the IRB. 2. SUBMITTING IND Safety Reports Following the guidelines set forth by federal regulations and OHRP, IND Safety Reports should only be submitted to Sterling IRB if, in the opinion of the Sponsor/CRO/SMO or Principal Investigator, the report meets at least one of the following conditions: 1. Information on the report results in an increased risk to all participants in the study. 2. Information on the report affects the rights, safety, or welfare of all participants in the study. 3. The report is for a device study. 4. The report is being submitted per Sponsor or Site requirements. For multi-site studies, Sterling requires the Sponsor to submit IND Safety Reports on behalf of the investigators. Investigators should not submit any IND Safety Reports to Sterling if reports are being submitted on their behalf. For single-site studies, it is the Principal Investigator's responsibility to submit all IND Safety Reports that meet one of the four conditions above. All IND Safety Reports concerning other sites that meet one of the four submittal conditions above should be submitted to Sterling IRB within 10 business days of receipt. 3. ACKNOWLEDGMENT of IND Safety Reports Acknowledgements for submitted IND Safety Reports will typically be sent out on a monthly basis. To learn more or if you have any questions, call 1-888-636-1062 (toll-free) or email us. |
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