An introduction to clinical trails in Europe
Content and Objective of the Course
The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.
This training provides first competences about medical device development in Europe. Furthermore it includes the responsibilities for investigators in clinical trials. It delivers essential knowledge for successful clinical trials. Please note that this training provides a general overview and does not attempt to fulfill the requirements of German ethics committees. For a certified training according to the German medical council please find our ISO14155-Basic-Training.
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.
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 online training consists of four modules, each lasting approx. 60 minutes:
- The Declaration of Helsinki and ISO14155:2020
- ISO14155:2020 - Responsibilities for Investigators (Part 1)
- ISO14155:2020 - Responsibilities for Investigators (Part 2) and Sponsors
- Content of essential Study documents
The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-4. After completing all modules and tests, the attendees can download and print the training certificate independently.
All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.
excl. 19 % Tax
Accredited by: NoneSign up for: ISO14155-International-Training