Content and Objective of the Course

In the EU member states medical devices were regulated completely different to pharmaceuticals due to different histories, economic reasons and a distinct mode of action. With the Regulation (EU) 2017/745 of April 2017 the market appoval for medical devices was streamlined. Consequently the regulations for conducting clinical trials with medical devices were updated. The objective of our training is the communication of current legal, ethical and administrative requirements as well as quality, scientific and practical aspects which are necessary for the conduct of clinical trials with medical devices in Europe. This training will support you to increase the quality of your clinical studies in accordance with the regulatory requirements.

The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations. The online training has been accredited by the Medical Association of Bremen. 18 Continuing Medical Education points (CME) have been assigned.

Instructions for participants and general conditions

The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years. The biometric module was created with assistance of Prof. Dr. Dr. Jürgen Timm and Mr. Werner Wosniok of the Competence Centre for Clinical Trials Bremen. It ensures that non-statisticians understand the approach of different study designs and the principle of sample size calculation.

The online training consists of eight modules, each lasting approx. 60 minutes:

1. Introduction: development of drugs and medical devices
2. Basics of biometrics: different study designs and sample size calculation
3. European Legislation on clinical trials with Medical Devices (MDR)
4. The declaration of Helsinki and ISO14155:2020
5. Investigator responsibilities part 1
6. Investigator responsibilities part 2 / Sponsor responsibilities / Audits
7. Important documents of clinical studies
8. Documentation and quality control of study data

The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a video presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions that will be generated randomly from a pool of 40 - 60 questions. After each failed test, the attendees receive a new set of 15 random questions, 80% of which need to be answered correctly to pass. Three test repeats are possible after which the attendee must start the module presentation again from the beginning. The individual modules can only be processed in the order of module 1-8. After completing all modules and tests, the attendees can print the training certificate independently. The certificate contains all topics required by the Ethics Committees and Competent Authorities to prove the qualification of clinical research staff according to ISO 14155.

All training modules within a training course must be completed within two months. If the two-month period has expired and the eight questionnaires have not been answered correctly, the online training must be restarted.