We previously posted a blog about Investigator Oversight that talked about the responsibility the Investigator has when working on a trial. At a recent site visit, it was discovered that the site had “accidentally” misplaced multiple investigational products. It was a scramble by the sponsor, the CRO, and the site to solve the mystery of “Where did the devices go”? According to 21 CFR 812.110(c), the investigator shall permit an investigational device to be used only with subjects under the investigator’s supervision. If devices are misplaced, how can this regulation be upheld?
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