On Thursday, September 6th, BioEnterprise hosted an event at Corporate College in Cleveland, Ohio. The training event focused on the differences between investigational drug and medical device clinical trials.  Featured speakers for the event were Sandra Maddock, CEO and President of IMARC Research and Brandy Smith, Chief of Clinical Operations for IMARC Research.

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.