- Introduction (00:06:00)
- Module 1 – Ethical basics (00:32:00)
- Module 2 – Legal basics (00:41:00)
- Module 3 – Methodological basics (00:36:00)
- Module 4 – Informed consent (00:38:00)
- Module 5 – Regular implementation (00:50:00)
- Module 4 & 5 – Practical exercises (00:05:00)
- Module 5 – GCP compliant changes (00:03:00)
- Module 6 – Adverse events and safety (00:34:00)
- Module 6 – Practical exercises (00:05:00)
Get Certified Today!
Do you need an MPG certificate to carry out clinical trials with medical devices? Would you like to deepen your knowledge? This Mastertrial MPG/GCP course is all online and is recognized by the Berlin Medical Association (CME). This Basic Course offers the following accredited training course for principal examiners, examiners and members of the examination group.
Download the MPG courses brochure
Aim of the course?
The course aims to provide you with the legal, ethical and methodological knowledge to be able to work as an examiner or a member of the examining group. In doing so, it is important to us that, in addition to the pure facts, we also provide you with methods and tools that enable you to carry out studies with medical devices in a competent and compliant manner.
Who should participate?
The course is aimed at principal examiners *, examiners, study coordinators, study nurses or technical staff who are involved in the implementation of medical device studies. * Please note that an advanced course is required for leading a test group as the main examiner.
Why take this course?
This interactive Meditrial video course on German medical device law is designed to give you the knowledge and skills to be able and allowed to conduct clinical trials in Germany. It provides you with the legally required MPG certificate to receive a positive vote from the ethics committee.
What I will learn?
This course will give you the relevant knowledge on the German legislation and international standards concerning clinical trials with medical devices based on the recommendations of the German Medical Association. Based on practical examples you will learn how to conduct a clinical trial in a compliant and efficient manner.
How will I be trained?
- 6 theoretical modules with video presentations (approx. 4 Hours)
- 2 practice-oriented modules with video presentations and Practice questions (approx. 2 hours)
- Self-study based on the additional Course material (depending on previous knowledge approx. 8-9 Hours)
- Learning success control approx. 3 hours
- Flexible in terms of time because the modules are processed individually
- Module 1 Test – Ethical basics
- Module 2 Test – Legal basics
- Module 3 Test – Methodological basics
- Module 4 Test – Informed consent
- Module 5 Test – Regular implementation
- Module 6 Test – Adverse events and safety
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