What happens when the Sponsor of a Clinical Research study does not follow their Responsibilities?

With the increasing surveillance / auditing by the investigative wing of the FDA / OHRP it behooves Physician and dentist Investigators to become familiar and knowledgeable regarding their responsibilities. To ‘think’ you know the rules of Clinical Research is not enough these days.

This Webinar will familiarize the PI and other investigators in a friendly Peer to peer manor of the current regulations that govern our activities and why not knowing the rules is an open invitation to be embarrassed when there is an FDA audit. When the PI signs the FDA form 1572 or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.

This talk, by a certified physician investigator, will go over the regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”. Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards), and 21 CFR 312 (Investigational New Drug Application / IND). For Device studies, 21 CFR 812 (Investigational Device Exemptions / IDE) is added in place of 21 CFR 312.

Additional responsibilities are clearly outlined in The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common sense.

This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Basically all persons involved in the conduct of Clinical Research studies will benefit.