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 * 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 The Office for Human Research Protections (OHRP) has composed a draft guidance for Sponsors, Principal Investigators and IRBs that can be used to determine which IND Safety Reports need to be submitted to the IRB. This draft guidance can be found online at http://www.hhs.gov/ohrp/requests/aerg.html. 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:
2. SUBMITTING IND Safety Reports To promote a more effective method of reporting and reviewing IND Safety Reports, Sterling IRB provides an IND Safety Report Cover Page, which should be submitted with each IND Safety Report that is sent to Sterling IRB. If you feel that an event described in an IND Safety Report meets one of the 4 conditions listed above, please complete an IND Safety Report Cover Page (one cover page per report). The IND Safety Report Cover Page allows Sterling IRB to quickly and efficiently assess the relevancy of an external adverse event to the safety and welfare of all study participants. If you are submitting an IND Safety Report that applies to multiple protocols under the review of Sterling IRB, please submit only one copy of the report and, on the IND Safety Report Cover Page, list all protocols to which the report applies. If you are an Investigator and your Sponsor/CRO/SMO is submitting IND Safety Reports on your behalf, you do not need to submit any IND Safety Reports to Sterling IRB. 3. ACKNOWLEDGMENT of IND Safety Reports While all safety information that is received at Sterling IRB is reviewed by the Chairman of the Board (or a designated Board member), Sterling will not acknowledge IND Safety Reports that are submitted without the IND Safety Report Cover Page, unless the Chairman, Board designee, or the full Board determines that the safety information meets conditions 1 or 2 above and requires a modification to the consent document and/or the study protocol. The Sponsor/CRO/SMO may request that Sterling IRB not acknowledge IND Safety Reports for a particular protocol if they consider it to be unnecessary. While IND Safety Reports that meet conditions 1, 2 and/or 3 above should still be submitted to Sterling IRB, there are no federal regulations that require that Investigators or the Sponsor/CRO/SMO receive written acknowledgment of these types of documents from the IRB. If you are not sure that an IND Safety Report meets one of the 4 submittal conditions, please reference the Investigator Handbook and review the criteria for reporting external adverse events. If, after referencing the Investigator Handbook, you are still not sure that an IND Safety Report should (or should not) be submitted to Sterling, please submit the document with an IND Safety Report Cover Page and attach an explanation if none of the 4 submittal conditions apply. call 1-888-636-1062 (toll-free) or email . |
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© Sterling Institutional Review Board