Good Clinical Practice for Investigators and Site Personnel
Learn the ICH-GCP requirements for clinical trials, understand the core principles, roles of investigators, and key processes in research. Avoid common inspection findings and prepare for successful site audits. Ideal for investigators, study coordinators, 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
[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 (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!
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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