Good Clinical Practice for Investigators and Site Personnel
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
- 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
[February 2023]: Added awareness of the most common GCP findings (lecture 4)
[January 2023]: Edited English subtitles, adding French subtitles
Welcome to the edition of the ICH-GCP (R2) course for Clinical Investigators & Other Site Personnel!
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 a ICH-GCP (R2) 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.
It provides full lifetime access to GCP Revison 2, and all subsequent Revisions of the GCP by the 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.
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 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 and key processes involved
The ICH-GCP Principles and practical advices to apply them in your clinical trials
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!
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
Vincent Baeyens, PharmD, PhD is a recognized expert with over 25 years’ global R&D and clinical operations leadership experience in Clinical Research.
He served as executive leader in several Global Pharma's and Biotech settings. He conducted Clinical Trials globally in Europe, US, India, Japan and Latin America.
Vincent holds a master’s degree in Pharmacy, from the University of Louvain in Belgium, and a PhD in Pharmaceutical Science, from the University of Geneva, Switzerland.