Course Content

This online training covers the ethical, regulatory, and operational aspects of clinical research. Participants will learn the principles of ICH GCP (R3) and ISO 14155:2026, as well as the requirements of key European regulations governing medicinal product, medical device, and in vitro diagnostic studies.

Course Modules

The course consists of four modules, each lasting approx. 60 minutes:

1. Core Ethical Principles of Clinical Research
2. Planning and Preparation for Conducting Clinical Research
3. Monitoring and Handling of Changes During a Study
4. Safety Reporting

Training Procedure

The modules must be completed in the specified order. There is a test at the end of each module, each of which contains 10 randomized questions from a question bank. Participants have three attempts per test, with randomized questions for each attempt. A minimum of 80% correct answers is required to proceed with the course. Answering the test questions takes approximately 15 minutes. The narration in this course uses an AI-generated synthetic voice. All educational content has been reviewed and approved by qualified human experts.

Advantages of an online training course

This flexible training allows participants to learn at their own pace, ensuring accessibility for busy professionals. Upon successful completion of all modules and assessments, participants in the full course receive a downloadable GCP Certificate.