Ethics Committee(EC) / Institutional Review Board Requirements
Ethics Committee(EC) / Institutional Review Board Requirements
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.
ID: 46
40 minutes
2 modules
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
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
General Requirements for WMDO Courses
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Course Access Duration: Each course is available for 60 days from the date of assignment.
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Quiz Completion: Users are allowed 2 attempts to complete each quiz, with a minimum passing score of 75%.