Program Description

Medical Device GCP for Investigators

Estimated Learning Duration of the Program:
Program Description:

This indispensable 6 course suite provides Investigators and clinical investigation site personnel with a comprehensive introduction to the medical device regulatory environment and offers an in-depth look at the criteria every investigator should consider before making the decision to participate in a medical device clinical investigation.
You will learn what the ethical and legal requirements are, how to ensure a successful initiation of the investigation and how to collaborate effectively with the sponsor during the investigation as well as the requirements of closing down a clinical investigation.

The courses part of this Suite have been developed according to the requirements outlined in:
ISO 14155:2011 – Clinical Investigation of medical devices for human subjects – Good clinical practice
21 CRF part 812 – Investigational device exemption
Declaration of Helsinki
21 CRF part 50 – Protection of Human Subjects


Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:
• Recognize the differences in conducting medical device clinical investigations versus pharmaceutical trials

• Make sound decisions as to whether or not to participate in a clinical investigation based on essential criteria
• Prepare, conduct and close a clinical investigation in an efficient manner in compliance with the regulations.

Program Pricing

Prices have not been set for this program.