Compliance In Focus

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?

According to the regulations for clinical trials, the PI is personally responsible for conducting and supervising the conduct of human subjects research by “protecting the rights, safety, and welfare of subject’s under the investigator’s care”.  The PI also has to ensure that all the research he is responsible for is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. So what exactly is “oversight”?  Oversight is defined in the Webster’s online dictionary as “management by overseeing the performance or operation of a person or group; watchful care, superintendence, general supervision”. As you can imagine, this can be quite an undertaking.