Course Description

GCP for Investigators: Clinical Investigation Close out or Termination

Course Description:

This course examines the circumstances in which a clinical investigation may need to be suspended or prematurely terminated and the role of each party involved. It outlines all major activities required to close clinical investigations, including mandatory reporting to sponsors, ethics committees, institutional review boards, competent authorities, or the FDA.

The content of this course is based on:

  • ISO 14155: 2011: 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:

  • Perform the appropriate actions to suspend or prematurely terminate a clinical investigation
  • Conduct all necessary close-out activities at the end of a clinical investigation

Who Should Enroll:

Principal and co-investigators, study coordinators, site managers, and hospital or ancillary staff involved in the clinical side of medical device clinical investigations are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • GCP for Investigators: Introduction to Medical Devices (ID 193)
  • GCP for Investigators: How to Qualify for Medical Device Clinical Investigations (ID 200)
  • GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations (ID 212)
  • GCP for Investigators: Clinical Investigation Conduct and Reporting (ID 204)

Subject Matter Expert:
Danielle Giroud

23 min

Related resources:

Case studies:

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