Obligations of Investigators in Conducting Medical Device Trials
This course addresses the requirements for conducting clinical trials for investigational premarket medical devices. It provides an overview of the clinical investigator’s general and specific obligations to protect human subjects while providing valid data that sponsors may submit to regulatory authorities for approval. This course also introduces documentation and reporting requirements, the inspection process, and the consequences for failure to comply with good clinical practice. It concludes with suggestions for improving compliance.
After this course learners will be able to recognize the requirements for conducting medical device research including following a protocol, safety and reporting standards, and documentation requirements. identify recommended procedures to follow during a regulatory authority inspection. recognize the consequences of noncompliance.