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Hi all,
I am inquiring about reportable events (protocol deviations, adverse events, etc.) for studies that are ceded to an external IRB (whether commercial or another institution). We have well-defined criteria and guidance for reportable events when we are the IRB of Record, but we want to better specify our submission expectations for ceded studies.
We advise study teams to submit reportable events according to the external IRB’s SOPs. They are required to submit reportable events to us if there is a determination of non-compliance, suspension of research, or if local context considerations are impacted.
Do any of your institutions have a guidance document or SOP available to study teams for this topic? How much do you want reported to your IRB if the study is ceded? What requires immediate reporting vs reporting at time of continuing review?
Thanks in advance for your responses!!
Hi Virginia,
Our policies on this topic are very similar to yours. We direct study teams to report events that meet our own definition of a major or minor deviation to the IRB of record in accordance with their reporting policies. Investigators do not need to report major or minor deviations to the local IRB; however, they do need to notify the IRB of any serious and/or continuing noncompliance determinations made by the IRB of record regarding events that occurred at the local site. This is submitted to the local IRB within 7 days of notification via a Reportable Events and New Information form.
This information is written into our HRPP policies that are available to investigators, and we have an section built into our quality assurance review report template reminding investigators of this requirement. Beyond that, we do not have any guidance documents or SOPs on this specific topic.
Hi Virginia,
At Cedars-Sinai we do require dual reporting to the IRB of record and to our local IRB in accordance with our own reporting policy. This is because we cannot cede our responsibility to oversee subject safety for research conducted by our investigators at our facilities. Our IRB cannot make any regulatory determinations (UPIRSO, serious/continuing noncompliance), but the reports are still reviewed through an expedited process to ensure there are no local context concerns. We are unable to share the actual policy externally, but this has been the case for every reliance agreement (commercial, academic) since we began ceding IRB review.
Best,
Leah
Leah Silbert, MPH, CIP, CCRP
Pronouns: She, Her, Hers
Manager, Research Compliance & Post Approval Monitoring
Office of Research Compliance &Quality Improvement
leah.silbert@cshs.org
Cedars-Sinai
6500 Wilshire Blvd, Suite 1800 : Los Angeles CA 90048
office 310‐423‐4149 : cedars-sinai.org
