The Medical Research Act of 23 October 2024 gave the Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V. (AKEK) the authority to draw up guidelines for the assessment of clinical trials by ethics committees. On 12 July 2025, the first such guideline (link to German text, not available in English) regulating the assessment of investigator qualifications by ethics committees came into force.
This guideline, which was developed together with the German Medical Association, is binding for all ethics committees that assess clinical trials with medicinal products, clinical trials with medical devices and performance studies with in-vitro diagnostics. Although there were already recommendations for the assessment of investigators, these only partially achieved the goal of harmonising the requirements of the ethics committees. Due to the binding nature of the new guideline, the assessment standards for investigator qualification are now clearly defined.
The revised curricula for basic, advanced and refresher courses for investigators and medical members of trial teams (‘GCP courses’) are also integrated into the guideline. One major innovation is the elimination of the previous division into courses for drug trials and those for medical device trials. The three course formats will now always address both subject areas. In order to maintain the length of the courses, the curricula will now focus more on those aspects that are particularly relevant for the practical implementation of clinical trials by the trial teams. The previous concept of an update course for significant regulatory changes remains in place. The AKEK has announced that it will provide information in its FAQs if an update course is deemed necessary. The working group does not consider the recently enacted revision of ICH-GCP (ICH E6 (R3)) to be a significant change for investigators, so no update course is required.
The guideline contains a transitional provision that allows the investigator qualifications to be verified and assessed on the basis of the previous recommendations until 30 June 2026. It also clarifies that the certificates for GCP courses completed by 30 June 2026 in accordance with the previous curricula will remain valid after the end of the transition period.
A first revision of the new guideline is already planned for 2026. Information on the assessment documents to be submitted for clinical trials with medical devices and performance studies with in-vitro diagnostics will then be included. The first version of the guideline initially only contains this information for clinical trials of medicinal products. It is also planned to include requirements for the qualifications of non-physician members of the trial team in the first revision.
Latest update: 22 July 2025