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Good Clinical Practice Refresher for Investigators

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Complete, Certified ICH GCP E6 (R3) Course for Investigators and Site Personnel

Welcome !

What you’ll learn

  • Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials.
  • Learn the core principles of ICH-GCP R3 and how to implement them in practice.
  • Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators.
  • Understand the purpose of the essential documents and the best practice for filing in the TMF.
  • Understand the essential requirements and contents of the Investigator’s Brochure and the Protocol.
  • Practice on real cases: Identify common ICH-GCP inspection findings (FDA warning letters) and how to avoid them.
  • Practice on real cases: Conduct a gap analysis in your organization based on a real MHRA inspection report.

Course Content

  • Principles of ICH-GCP (R3) –> 2 lectures • 52min.
  • Responsibilities of the Investigator –> 12 lectures • 43min.

Good Clinical Practice Refresher for Investigators

Requirements

Welcome !

This course is a refresher ICH GCP course for Investigators and staff personnel requiring to maintain up-to-date their knowledge in GCP.

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

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. I have worked with most of the Global as well as several niche CROs and I am also an expert in CRO Management and Oversight, budgeting and Risk Management.

I will lead you step-by-step through the ICH GCP E6, and you will learn & 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 involved and essential documents
  • The ICH GCP Principles and practical advices to apply them in your clinical trials
  • The detailed responsibilities of the Investigator throughout the trial, including his/her qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reporting

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

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