Course Description

Medical Device GCP: A Practical Summary

Course Description:

This course focuses on medical device Good Clinical Practice (GCP) and provides a comprehensive summary of its essential elements, including a brief regulatory background.

It covers the following topics:

  • Navigating the ethical and legal requirements of GCPs
  • Practical examples of GCP principles
  • Ensuring a successful initial investigation
  • Setting up efficient collaboration between all parties to ensure compliance during clinical investigations
  • Necessary requirements to suspend or shut down a clinical investigation

The content of this course is based on:

  • ISO 14155: 2020: Clinical Investigations of Medical Devices for Human Subjects
  • The Declaration of Helsinki
  • 21 CRF 812: Investigational Device Exemption
  • 21 CRF 50: Protection of Human Subjects

Disclaimer: Please note that under certain regulations, this summary course may not be sufficient for investigators to obtain authorization to conduct medical device clinical investigations. This course is specifically designed for professionals who need a summarized knowledge of medical device GCP. It does not provide sufficient in-depth knowledge for a rigorous approach, such as that needed for Investigators and clinical coordinators. For that specific aim, the six-course series “Medical Device GCP for Investigators” has been developed.


Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Identify what essential criteria must be taken into account during site selections
  • Understand the main objectives involved in the preparing, conducting, and shutting down clinical investigations in an efficient manner that complies with regulations

Who Should Enroll:

Principal investigators, co-investigators, study coordinators, and key personnel involved in conducting clinical investigations are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

The following course is required:

  • History of Good Clinical Practice (GCP) (ID 41)

Subject Matter Expert:

75 min

Related resources:

Case studies:

Basic Account: € 243.00
Premium Account: € 183.00

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