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Good Clinical Practice ICH-GCP R3 for Clinical Investigators
Rating: 4.4 out of 5(42 ratings)
86 students

Good Clinical Practice ICH-GCP R3 for Clinical Investigators

[2026] A Complete, Certified Course ICH-GCP R3 tailored for Clinical Investigators Sites
Created byDr. Vincent Baeyens
Last updated 11/2025
English

What you'll learn

  • Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
  • Learn the 13 core principles of ICH-GCP and how to implement them in practice
  • Define the roles and responsibilities of Investigators
  • Identify common ICH-GCP inspection findings and how to avoid them
  • Define the roles and responsibilities of each involved key stakeholder, and key processes in clinical research

Course content

5 sections • 17 lectures • 2h 20m total length

  • What is ICH-GCP (R3) ?11:18
  • What is GCP?
  • Common GCP Findings at Clinical Investigator Sites12:25

    Presentation of the most common GCP findings at the Clinical Investigator sites, Sponsors and CROs

Requirements

  • No prior working experience or knowledge in clinical research is required to attend this course
  • This course is dedicated to beginners as wells as to more advanced Investigators or Site staff willing to refresh their knowledge

Description

[November 2025]: Upgrade to Revision 3 of ICH-GCP

[February 2023]: Added awareness of the most common GCP findings (lecture 4)

[January 2023]: Edited English subtitles, adding French subtitles

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Welcome to the edition of the ICH-GCP (R3) course for Clinical Investigators l!

This course meets the Minimum Criteria for ICH E6  GCP Investigator that TransCelerate has identified as necessary to enable mutual recognition of GCP training.

This course offers a  ICH-GCP  course for Investigators, Co-investigators, Study Coordinators,  and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials at Clinical Sites.

My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma, and Biotech settings.

This course is based on my experience of the key ICH-GCP requirements to conduct a clinical study as an Clinical Investigator and study site personnel. We will review the role and responsibilities of the Investigators.

This course will provide you with a strong foundation to prepare for successful site regulatory ICH-GCP inspections and audits.

I will lead you step-by-step through the ICH-GCP E6 with a focus on Investigators responsibilities.

You will learn and understand:

  • What is GCP and why GCP is important in clinical research

  • The definition of the key definitions of terms and concepts used in clinical research, including stakeholders and key processes involved

  • The ICH-GCP Principles

  • The detailed responsibilities of the Investigator throughout the trial, including qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reporting

  • The common ICH-GCP audit and inspection findings in clinical trials and how to avoid them

Quizzes will consolidate your knowledge.

Feel free to look at the content of the course to know more and contact me any time if you have any questions!

I am looking forward to seeing you inside the course!


Sincerely,


Vincent

Who this course is for:

  • This course is intended to Investigator, study nurse, study coordinator or other study site personal willing to comply with ICH-GCP

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