Course Description

GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations

Course Description:

This course provides a comprehensive outline of the Ethics Committee (EC) or Institutional Review Board (IRB) submission process. It explains logistics for smoother processing and describes in detail how to prepare for the informed consent process; what is important and what constitutes as an essential element.

This course also examines the legal implications of investigator agreements, important facts regarding clinical investigation insurance, and the process for obtaining regulatory approval from competent authorities.

The content of this course is based on:

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

Learning Objectives:

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

  • Prepare ethics committee submissions and be prepared for any questions concerning the clinical investigation at hand
  • Conduct the informed consent document and process
  • Understand the essential legal points of the investigator or research agreement
  • Ensure appropriate insurance certificates are in place
  • Recognize that national regulations may require approval from competent or health authorities before medical device clinical investigations can begin
  • Determine how to collaborate with sponsors and when to delegate any of the above tasks

Who Should Enroll:

Clinical site investigators, study coordinators and nurses, administrators, and those performing clinical investigation activities at clinical sites are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

The following course is required:

  • GCP for Investigators: Introduction to Medical Devices (ID 193)

Subject Matter Expert:
Danielle Giroud

25 min

Related resources:

Case studies:

Basic Account: € 84.00
Premium Account: € 63.00

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