Auditing Ceded Studies

We recently audited a study that was ceded to an external IRB due to a complaint our local IRB received. We conducted the audit and reported all the issues found to the external IRB. Per our local policies even if a study is ceded to another IRB, the site should still report local deviations and adverse events. The external IRB reviewed our audit, but our local IRB made additional requests due to the local non-compliance that was occurring. This was our first time dealing with this situation. We definitely need to add to our policy manual on how to handle these items in the future.

Hi Kate!  We don’t have a separate policy for auditing ceded studies, but our process is impacted a bit.  Our scope of review is the same from the study team’s perspective – meaning, we’re still evaluating the contents of their Regulatory Binder to ensure that they have all relevant IRB submissions and have done any required reporting to both the IRB of record and to our local HRPP office if applicable, and we’re still selecting the same percentage of subjects for review. 

But, our “pre-audit” process changes as we need to first obtain the relevant IRB records so that we can establish the “history” of the study and its approval parameters (how many protocol or ICS changes have there been, what were the IRB approval parameters, etc.).  So, we do ceded study audits in 2 parts:  first we set up a secure Teams folder and give the study team a deadline to transfer the IRB records and applicable research policies for our review/familiarization; then we set a time to actually conduct the on-site audit.  Sometimes study teams are able to just give us access to the reviewing IRB’s portal or whatever platform the lead site/coordinating center has set up for management of the IRB submissions.  

Then, our “post-audit” process also changes.  We tee up items that appear to us might require reporting to the IRB of record (based on their policies) and instruct the study team to complete any reporting directly (rather than us getting involved in that process).  Some observations may still require reporting to our local HRPP (even in ceded studies), but the study team also does that on their own (we don’t submit on their behalf).  So, this process isn’t that different for us.    Let me know if you want to talk further!

Neala, Indiana University

 Hi Kate! For both routine QA reviews and for-cause/targeted audit, my institution (Boston Medical Center/Boston University Medical Campus) conducts reviews of ceded studies more or less same way we would for a local IRB study. This applies to our processes for selecting a study for review (no difference in priority for ceded or non-ceded studies), scope of review (what we examine when we conduct a review), etc.
In review reports, we use our institutional terms/definitions (major deviations, minor deviations, etc.) to categorize findings. However, since an external IRB may use different terms/definitions and the investigator would not be reporting deviations to the local IRB, we instruct the study team to a) examine whether this finding would meet the external IRB’s reportable finding definitions, and b) report as necessary, adhering to the external IRB’s prescribed timeframes. Without being an expert in the external IRB’s reportable finding definitions, it would be difficult for us to confidently sort findings by their standards; thus, we put the onus on study teams to do so (or consult the IRB/sponsor for help).
We do not share the review report with the external IRB. However, for QA reviews, if there are any possibly reportable findings our Director of the Office of Human Research Affairs/HRPP will reach out to the external IRB to ask whether the findings have been reported by the team (after a reporting grace period).
Hope that helps!