At Advarra, we often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some are addressed specifically in the regulations; some are covered in regulatory guidance documents; and some are left to be defined by individual IRBs’ policies. In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
As those familiar with medical device research are likely aware, there is some variation in the way medical device studies are regulated as compared to the regulations governing drug studies. When it comes to reporting to the IRB, however, the regulations are thankfully fairly similar.
According to FDA’s 2009 guidance document on adverse event reporting to IRBs, IDE regulations “require sponsors to submit reports to IRBs in a manner consistent with the recommendations made…for the reporting of unanticipated problems under the IND regulations.” However, the IDE regulations contain a term unused in the IND regulations: unanticipated adverse device effect, or UADE.
What Is an Unanticipated Adverse Device Effect (UADE)?
A UADE is “any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects” (21 CFR 812.3[s]).
Investigators should report UADEs to the sponsor and to the IRB as follows:
- Investigators are required to submit a report of a UADE to the sponsor and the reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator first learns of the event (21 CFR 812.150[a]).
- Sponsors must immediately conduct an evaluation of a UADE and must report the results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days after the sponsor first receives notice of the effect (21 CFR 812.46[b], 21 CFR 812.150[b]).
Prior to submitting any UADE report to the IRB, investigators should confirm that the reports have not been submitted on their behalf by the sponsor.
At Advarra, when SAEs or safety reports that do not meet the UADE criteria are submitted to the IRB, the submitting party will receive acknowledgement of receipt only. The item will not be reviewed by the IRB. When these items are submitted by a sponsor or CRO, Advarra’s default process is to generate an acknowledgement of receipt to all open sites, though sponsors/CROs may opt out of this process.
Need information on reporting unanticipated problems involving risk to human subjects or others (unanticipated problems or UAPs)? Read our blog Reporting to the IRB: Unanticipated Problems and Serious Adverse Events (SAEs) in Drug Studies.