Course Description

CPM: Compliance Management during Medical Device Clinical Trials

Course Description:

This course provides tools for ensuring compliance with regulatory and Clinical Investigation Plan (CIP) requirements during clinical investigations by all parties.

Learning Objectives:

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

  • Ensure efficient management of clinical investigations in order to obtain results that conform to the agreed-upon objectives
  • Determine which of the following is the ultimate goal for project managers:
    • Further product development
    • Product registration
    • Product publication
    • Obtaining data that complies with regulations

Who Should Enroll:

Clinical project managers, senior clinical research associates, regulatory and quality assurance managers, and professionals with managerial clinical roles involved in the planning and setting up of clinical investigations for medical devices are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • CPM: Objectives and Setup of a Medical Device Clinical Trial (ID 97)
  • CPM: The Clinical Trial Master Plan for Medical Devices (ID 98)
  • CPM: Medical Device Clinical Trials – Budget and Timeline Planning (ID 99)
  • CPM: Medical Device Clinical Trial Team Resources (ID 100)
  • CPM: Tracking and Reporting Rules for Medical Device Clinical Trials (ID 101)
  • CPM: Project Guidelines for Medical Device Clinical Trials (ID 102)
  • CPM: Managing Ongoing Medical Device Clinical Trials (ID 103)

Subject Matter Expert:
Danielle Giroud

40 min

Related resources:

Case studies:

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