Focus Module: ICH GCP E6(R3) - Summary of Essential Changes

In a module lasting approximately 45-60 minutes, participants can acquire basic knowledge about the changes introduced by ICH GCP E6(R3). Upon successful completion of the training, an ICH GCP E6(R3) certificate can be downloaded, which contributes to maintaining high quality in clinical trials.

Our focus module concept

The concept of in-depth modules was created with the new curriculum published by the German Medical Association in July 2025. Part of the refresher training is a flexible in-depth module with customizable content. Clintrain creates a selection of standalone focus modules for you, which can be booked alone or in combination with the refresher training—accredited and with continuing medical education ponits from the Bremen State Medical Association.

This training does not replace regular participation in a curricular refresher training course.

Accredited and certified GCP training

At the end of the refresher training course, participants can conveniently download and print out their GCP certificate themselves. The certificate details the content and scope of the GCP training, thereby meeting the requirements of ethics committees.

Description and content of the training course

This GCP refresher course was designed by Dr. Andreas Grund, based on 18 years of professional experience in clinical trials. The result is a highly practical training program. The course covers the ethical, legal, and administrative principles required for clinical trials and addresses common misconceptions in the professional practice of clinical research. Our training content is continuously updated to ensure that it always complies with current legislation (without guarantee).

Training content

Our training course “Focus Module: ICH GCP E6(R3) - Summary of Essential Changes” consists of one module that can be accessed online and takes approximately 45-60 minutes to complete. Topics covered include:

1. Risk-based quality management
2. Risk-based monitoring
3. Data processing
4. Resource allocation
5. Study accessibility

Training procedure - conveniently download your certificate online

All modules must be completed in the specified order. Each module consists of a presentation lasting approximately 30-45 minutes and a test to assess learning progress.

The tests consist of 10 randomized questions. Participants have three attempts to successfully complete each test. The questions are randomized each time the test is taken. At least 80% of the questions must be answered correctly in order to continue with the GCP refresher course. It takes approximately 10 minutes to answer the questions.

In accordance with the requirements of the Medical Association, the entire course must be completed within a period of two months in order to obtain the GCP Refresher Certificate online. If this period has expired and not all tests have been successfully completed, the course must be restarted in whole or in part.

We will report your continuing medical education (CME) credits to the Bremen Medical Association on your behalf. These are submitted to the Bremen Medical Association once a year at the end of May. Please provide your continuing education number (EFN) when booking.

Advantages of online GCP training

Conduct your training courses online with us now. With our advanced module on Revision 3, you are independent and can learn wherever and whenever it suits you best. All you need is a computer or tablet, stable internet access, and an up-to-date internet browser. Once you have selected your individual start date, you can participate in our training course online at any time within two months.