{"result": "SUC", "course": 68, "description": "

Course Content

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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.

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Course Modules

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

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

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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.

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Advantages of an online training course

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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.

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