Course Description

Clinical Protocol Writing Process and Ensuring Compliance

Course Description:

This course covers the essential regulatory and ethical requirements for ensuring compliance, traceability, and efficiency during the clinical investigation process so that all efforts lead to meaningful results. It also provides the essential steps for creating a quality assurance system.

Learning Objectives:

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

  • Ensure a process is in place for writing efficient clinical investigation plans
  • Prepare the necessary and standard operating procedures and templates to optimize global compliance

Who Should Enroll:

Clinical project directors, senior clinical project managers, and senior regulatory managers are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • ISO 14155: In-Depth Review (series; IDs 61–67)
  • The European Union Regulatory System for Medical Devices (ID 145)
  • The Japanese Regulatory System for Medical Devices (ID 146)
  • US FDA 510(k) Notification Process (ID 92)
  • US FDA Investigational Device Exemption (IDE) Overview (ID 121)
  • Format and Structure of a Medical Device Clinical Investigation Plan/Protocol (ID N140)
  • Complaint Handling and Reporting Process for Medical Devices (ID 141)

Subject Matter Expert:

35 min

Related resources:

Case studies:

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