I am having trouble finding guidance on your website regarding reporting requirements for deviations that do not meet the requirements for being “promptly reportable”. Should a “one-off” major protocol deviation be reported to IRB? I have a site that did not report a serious adverse event (SAE) within 24 hours, but this did not put the patient at risk of harm. Should this be reported by the site the IRB?
– Clinical Research Associate, Pharmaceutical Company
Consistent with FDA Guidance, WCG IRBs require reporting of adverse events only when the adverse event or IND safety report requires a change to the protocol or consent document. For protocol deviations, reporting to WCG IRBs (including WIRB) is required only for deviations that harmed a subject or placed subject at risk of harm or a deviation made without prior IRB approval to eliminate an immediate hazard to a subject.
For protocols approved by WCG IRBs, reporting requirements are defined in the WCG Policy HRP-071. The WCG submission form, Promptly Reportable Information, also provides a list of reportable events to help research sites and sponsors determine when reporting to the IRB is required.
Based on the information provided, neither the SAE nor the deviation from the sponsor’s reporting requirements needs to be reported to the IRB.
Your example was a “one-off”; but, a series of such delays or a general pattern of lack of attention to adverse event reporting to the sponsor may indicate an issue that places subjects at risk of harm requiring prompt reporting to the IRB. A short delay of reporting a non-research related SAE to the sponsor is different than a long delay of reporting an SAE related to the research and indicative of potential risks for other subjects.
Note that reporting requirements may vary across IRBs.