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How often are institutions conducting monitoring visits?
silbertl 08/01/2024 6:06 pm
@bethany We conduct routine auditing of 12 studies per year on average. We also conduct at least one limited routine audit of consent forms only, which includes about 7-14 studies usually based at affiliate sites to the main campus, as these studies tend to not be captured in our routine auditing program. My team also provides ongoing QA monitoring services for out investigator-initiated trials when our sponsor-investigator holds an IND or IDE in their own name. These QA monitoring visits take place at a cadence determined by the risk-based QA monitoring plans we develop for such trials.
It depends
Pre-covid we were auditing investigator initiated studies 5-7 per month. This past year we didn’t get to many of the not for cause audits thanks to many issues with consents from COVID. I hope to get us back there this year.
Our audit “quota” differs between our 2 audit teams. Our Full Board/Greater Than Minimal Risk auditors are each expected to conduct 2 “onsite” audits per month (so 2 studies per auditor per month). This typically works out to them being “out on site” (mostly throughout the Indianapolis campus where our Schools of Medicine, Nursing, and Dentistry all live) about every other week. Our Expedited/Minimal Risk auditor completes between 3-4 remote audits per month. That puts our annual total at ~50 audits of Full Board research (2 auditors x minimum 24 audits each per year) and another 40-45 audits of Expedited research.
In terms of “frequency” for a single study – we’re “one & done” meaning we do not ever return to re-review the same study UNLESS an IRB would direct a follow-up audit, or the study team would request one later down the line.
My audit team does not have any role in “ongoing monitoring” for PI Held IND/IDE studies (which is handled through our CTSI services).
