Course Description

GCP for Investigators: Initiation of a Medical Device Clinical Investigation

Course Description:

This course reviews how investigators and their teams should prepare for initiation visits and actively participate in site initiation activities. It outlines how to organize and implement fully operational investigation sites that are compliant with Clinical Investigation Plans (CIPs), Good Clinical Practices (GCPs), and other applicable regulations.

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 and participate in an initiation visit
  • Follow up on post-visit site action items

Who Should Enroll:

Clinical site investigators, study coordinators and nurses, administrators, and those performing clinical investigation activities at clinical sites 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)

Subject Matter Expert:
Danielle Giroud

30 min

Related resources:

Case studies:

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Premium Account: € 72.00

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