Course Description

CPM: Close Out and Clinical Report of a Medical Device Clinical Trial

Course Description:

This course covers practical project management activities for effective clinical investigation close outs, as well as how to prepare, write, and finalize clinical reports.

Learning Objectives:

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

  • Ensure clinical investigations close out in a compliant and timely manner
  • Develop methods for continuous improvement of project management skills that will ensure efficiency between projects and provide continual career development

Who Should Enroll:

Clinical project and regulatory managers, senior clinical research associates, and professionals with managerial clinical roles involved in planning and setting up 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)
  • CPM: Compliance Management during Medical Device Clinical Trials (ID 104)
  • CPM: Effective Communication Methods during Medical Device Clinical Trials (ID 105)

Subject Matter Expert:
Danielle Giroud

30 min

Related resources:

Case studies:

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