Good Clinical Practice for Clinical Research Professionals

Description

Updates:

January 2024: Updated Bonus section; added the ICH-GCP (R3) Overview of comments received on Step 2. Comments will now be sent to the ICH E6 (R3) Expert Working Group for consideration in the context of Step 3 of the ICH process.

September 2023: Updated section of ICH GCP R3 Draft Principles and added resource documentation

August 2023: Added list of Acronyms and Abbreviations used in the course (section 1)

June 2023: Added DRAFT ICH GCP (R3) Annexe 1 (interventional clinical trials), its summary of changes and explanatory video in the resources. This version is made available by the ICH for public consultation until September 2023 (step 2 of the ICH process)

May 2023: Added link to ICH E8 (R1) in resources of quality management

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

January 2023: Edited English subtitles, adding French subtitles

December 2022: Added assignment: Practical risk assessment based on UK MHRA inspection report (section 11)

October 2022: Added assignment: Practical exercises from real FDA inspection cases (section 10)

September 2022: Added updates on ongoing development of Revision 3 of ICH-GCP (section 12)

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Welcome to the only up-to-date, complete edition of the ICH GCP  course!

This course meets the Minimum Criteria for ICH E6 (R2) GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training.

This course offers the first professional, fundamental on-line ICH GCP (R2) detailed course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials. This ICH-GCP course also presents elements of ICH GCP E6 (R3) as they become available currently under revision by ICH.

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. 

In this course, you will be able to understand based on my experience the key ICH GCP requirements to design, conduct, record and report clinical trials in humans from A to Z. We will review the role and responsibilities of the key stakeholders and the structure of the essentials documents.

To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.

Note: If you are a more advanced student, you can increase the speed of lecture to learn the course at your own pace.

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

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 link between the Declaration of Helsinki and current GCP

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

• The ICH GCP Principles of Revision 2 and Revision 3 and practical advices to apply them in your clinical trials

• The responsibilities of ethics committees,  its composition, function, operational aspects and obligations

• 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

• How to write an adequate Protocol / protocol amendment and rationale for its structure

• The What, the Why and the How for an effective writing of the Investigator's Brochure

• The purpose of Essential Documents in clinical research: How and Where to file them in the Trial Master File (TMF)

• The common ICH GCP audit and inspection findings in clinical trials with practical exercises (FDA, MHRA)

  
  

I will illustrate the GCP concepts with several practical tips & tricks , so that you will be able to apply ICH GCP to your daily practice from Day 1!

Quizzes are proposed to test your knowledge along your journey. A final Quiz at the end of the course 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!

After the course, spend 1 hour with the EXPERT to answer ALL the questions that you would have!! All you have to do is to send me an e-mail with your questions and contact details, and I will set up a call with you.

I am of course available personally during the course as well to answer your questions or comments!

I am looking forward to seeing you inside the course!

Sincerely,

Vincent

What You Will Learn!

• Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
• Learn the core principles of ICH-GCP R2 and 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

Who Should Attend!

• This course is intended to all professionals involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ICH-GCP

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