Training for investigators

When physicians participate in clinical trials to test new medical products or medical devices, they must be especially qualified in the following respects:

  1. They must be experts in the field for which the new products are being developed.
  2. They must ensure that ethical principles and legal regulations are observed.

The Association of Medical Ethics Committees, together with the Executive Board of the German Medical Association and the Standing Conference of the Management and Chairs of the Ethics Committees of the State chambers of physicians, prepares the curricula for the continuing education of physicians who wish to participate in a clinical trial.

The curricular courses convey the relevant content and always require updating, since, for example, the legal framework changes significantly with the application of EU-Regulation 536/2014 (CTR) and EU-Regulation 2017/745 (MDR). Likewise, ethical principles need to be adapted to new technologies. For example, the Taipei Declaration (2016) sets out new recommendations for research involving health data and biobanks. Thus, the curricular courses listed below also serve to harmonize.

The regulations and recommendations for the trainings of investigators are only available in german.