On 01. April 2019 the recommendations for the assessment of the investigator’s qualifications in clinical studies published by the `Arbeitskreis Ethikkommissionen´ were replaced by a new version which was passed by the Bundesärztekammer on 13./14. December 2018. The new recommendation comes along with some important changes, especially clinical expertise is more recognized now. In the future, the obligation to attend an Arzneimittelgesetz (AMG) Refresher Courses regularly no longer applies if the investigator has ongoing training via the conduct of trials. Only in case of regulatory changes, a two hours Update Course has to be passed to be familiar with the recent regulatory landscape and possible changes. Furthermore, course content that is more relevant for daily work has become more important within the new recommendation. For an investigator who has ongoing experience approved by the Ethics Committee, an AMG Advanced Course, a one-day course with contents more relevant for practical work, is sufficient to get the permission for conducting clinical trials. Formerly, investigators had to complete a second one-day course, the AMG Basic Course, with an emphasis on the legal basis of clinical trials.
The changes regarding qualification of investigators performing clinical trials with investigational medicinal products according to AMG also apply to clinical investigations with medical devices under Medizinproduktegesetz (MPG). In addition, investigators who are experienced and qualified in conducting trials according to AMG, have to complete just an MPG Supplementary Course to be sufficiently qualified for performing clinical investigations with medical devices. For an overview of the new qualification process for investigators, co-investigators and the medical team for AMG and MPG studies, we have prepared the figure below.
The new recommendation is more explicit than the one before, which allowed for interpretation. This fact might explain the discrepancies in previous decisions of different Ethics Committees regarding the qualification of investigators. Time will tell if the Ethics Committees will follow the new recommendation. In any event, there is hope: In the framework of the national implementation of the EU directive Nr.536/2014, the principle of local responsibilities of the Ethics Committees is excluded. For the ethical evaluation of a trial the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) will assign Ethics Committees out of a national register. Within the registration process for this nationally harmonized procedure, which is expected in 2020, Ethics Committees have agreed to follow the quality assessment standards for investigator trainings of the new recommendation as part of a voluntary obligation.
As a reaction to the new recommendation, SSS International Clinical Research offers the one-day AMG Advanced Course, which has become a central component in the training of the medical team. This new offer broadens the SSS GCP and MPG training program.
Find more information about the SSS training program .