A complete, certified ICH-GCP E6 (R2) course for Investigators, Study Coordinators and Site Clinical Research staff
Welcome to the complete edition of the ICH-GCP (R2) course!
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
- Introduction –> 3 lectures • 10min.
- Definitions of terms –> 5 lectures • 28min.
- The 13 Principles of ICH-GCP R2 –> 1 lecture • 10min.
- Responsibilities of the Investigator –> 10 lectures • 33min.
Requirements
Welcome to the complete edition of the ICH-GCP (R2) course!
This course offers the a fundamental 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.
This ICH-GCP 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. It provides full lifetime access to GCP Revison 2, and all subsequent Revisions of the GCP by the ICH. The course is updated on regular intervals to present the most up-to-date relevant information.
My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials (phase 1 to 4) 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.
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 Investigators.
This course will provide you with a strong foundation to prepare for successful site regulatory ICH-GCP inspections and audits.
To do so, I will lead you step-by-step through the ICH-GCP E6, and you will be able to 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
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!
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