Course Description

Ethics Committee(EC) / Institutional Review Board Requirements

Course Description:

This course provides an overview of the basic Ethics Committee (EC) and Institutional Review Board (IRB) requirements according to 21 CFR 56, ISO 14155, and international law. It offers a practical approach to the EC and IRB processes and explains how to effectively manage the processes to prevent delays.

Learning Objectives:

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

  • Plan and prepare EC and IRB submissions in compliance with applicable rules and regulations
  • Work together with investigation site personnel to ensure smooth and  efficient preparation and processes
  • Meet deadlines for submissions and avoid delays in clinical investigations
  • Ensure compliance in the documentation to and from the EC or IRB

Who Should Enroll:

Monitors, clinical project managers, investigators, study coordinators, and quality assurance, regulatory, and marketing professionals wanting to learn the basics of the EC or IRB submission processes are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

An understanding of the following material is required:

  • Basics of good clinical practice
  • Content and management of clinical investigation plan documents
  • Logistics in preparing, setting up, and conducting informed consent processes

Subject Matter Expert:
Danielle Giroud

40 min

Related resources:

Case studies:

Basic Account: € 143.00
Premium Account: € 108.00

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