Course Description

GCP for Investigators: How to Qualify for Medical Device Clinical Investigations

Course Description:

This course explains the importance of the clinical investigation site qualification process in determining whether a given clinical site has the appropriate resources to conduct an investigation.

The qualification process must provide principal investigators the opportunity to evaluate the scientific value, clinical value, and design of the device in question.

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 for and participate in a site qualification visit
  • Follow up on post-visit site action items
  • Perform regulatory and ethics submissions

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 course is required:

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

Subject Matter Expert:
Danielle Giroud

32 min

Related resources:

Case studies:

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Premium Account: € 72.00

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