As one of the main tasks of Magdeburg University Hospital, carrying out clinical research on human subjects in accordance with scientific and ethical principles requires researchers to proceed in line with a universal set of rules. This is the only way that the protection and safety of the test subjects and patients can be guaranteed. To this end, the competence of the members of the study team in clinical trials must be demonstrated to the Ethics Committee*.

To firmly define the necessary competences and as a possible guide for the recognition of continuing education measures, a curriculum was developed for the implementation of GCP courses. This was adopted by the Working Group of Medical Ethics Committees in its general meeting on 10 June 2016 and also the Board of the German Medical Association in its meeting of 16 September 2016.

The GCP training is offered in two separate courses at the IBMI (basic and advanced training courses). The basic course is aimed among others at medical documentalists, study nurses and investigating physicians and their alternates. The AMG advanced course is offered for investigators and alternates (physicians and scientists) who will lead a team of investigators pursuant to the AMG or Directive (EU) 536/2014. Participation in the AMG advanced course requires successful completion of the basic course. Up to now, the State Medical Association of Saxony-Anhalt has certified 10 continuing education credits for each course day. We reapply for the granting of continuing education points for each round of courses.

*Legal foundations:

- 12th Amendment to the German Medicines Act (AMG) (...)

- Regulation concerning the application of good clinical practice in the conduct of clinical trials on medicinal products for human use (GCP-V) (2004)

- Amendment to the German Medical Devices Act (MPG)

- Regulation concerning the clinical testing of medical devices (MPKPV) (2010) - - - Directive (EU) No. 536/2014 (Dir. (EU) No. 536/2014)

- ICH-GCP Guideline or ISO Standard 14155