This two-day course is designed for individuals who are responsible for Good Clinical Practice (GCP) compliance, including those who plan, oversee, conduct, monitor and audit medical device clinical investigations.  This includes, but is not limited to, sponsor personnel such as clinical scientists, clinical research associates, quality assurance personnel, safety reporting staff and document control managers.  The course will also benefit personnel from clinical trial sites, including study coordinators and Institutional Review Board (IRB).



Learning Objectives

Upon completion of this course, attendees will have a better understanding of GCP regulations and standards related to the conduct of medical device clinical investigations, and will have gained the background knowledge necessary to effectively plan, conduct and oversee these investigations.  Participants will review the roles of the sponsor, the investigator, the monitor and the IRB in the conduct of medical device clinical investigations.  Attendees will acquire insight into the common pitfalls identified during these clinical investigations and how to avoid them.

Course Description

GCP regulations and standards apply to medical device clinical investigations.  Failure to conform to these requirements may result in inadequate human subject protection and doubts about data quality and integrity. This course provides a comprehensive overview of the Food and Drug Administration’s (FDA) GCP regulatory requirements and expectations.  Course content will prepare attendees for carrying out or reviewing compliance with those regulations and expectations.  The course addresses GCP for clinical investigations of all medical device types, including significant risk, non-significant risk and in vitro diagnostic devices.

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