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. Currently, the FAQs do not yet contain any statements on the need for training with regard to the revision of ICH-GCP (ICH E6 (R3)) that recently came into force.

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: 17 July 2025

From 23 July 2025, a revised version of Good Clinical Practice (GCP) for clinical trials of medicinal products in humans will apply. The new version of this guideline prepared by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) with the official designation ICH E6 (R3) replaces the previous version (R2). The previously very concise basic principles have been formulated in more detail for the new version of the guideline and now represent the core document of GCP. This is supplemented by annexes that serve to interpret and apply the basic principles. Annex 1, which has already been finalised, focuses on interventional clinical trials. In terms of content, the newly formulated basic principles an Annex 1 replace the previous GCP version (R2). Annex 2 will soon complete the new GCP guideline. It will deal with additional considerations for special study designs, such as decentralised studies, pragmatic studies and studies with real-world data. The new GCP version (R3) is more closely linked to the ICH guidleine E8 (R1) on general considerations for clinical trials.

Presentations and videos of an EMA workshop from February 2025 on the new GCP version (basic principles an Annex 1) can be found here.

Under the motto "Fridays for Future" jung people all around the world campaign for a more vigorous fight against climate change. Likewise, in many German towns pupils and students came out on strike every Friday in order to publicly call attention to their cause.

We at CliPS think that this commitment is admirable und we are delighted to see that numerous scientists have meanwhile gathered under the name of "Scientists for Future" in order to support the pupils and students with scientific arguments. Our own professional discipline - clinical research - is home to countless scientists, many of whom have surely already contemplated the topic of climate change. We would like to ask all our colleagues to catch up on "Fridays for Future" and "Scientists for Future". If you speak German, please watch the video "Aufruf an die Politik" (call on politicians).

We have decided to sign the statment issued by "Scientists for Future" and we would be glad if as many colleagues from our branch of industry as possible could do the same.

The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI) jointly publish a quarterly drug safety bulletin called
 

You can find the current edition (German only) using this link.

Further news from the higher federal authorities:

It has become increasingly certain that EU Regulation 536/2014 (Clinical Trials Regulation) will finally come into effect in 2022. This regulation will mainly harmonize the procedures for obtaining approvals for the conduct of clinical trials with medicinal products in the EU. In order to prepare physicians (investigators) working in such clinical trials for this far-reaching revision of the regulatory framework the German Medical Association and the German Ethics Committees in summer 2020 published a curriculum for an update course (available in German only). You can find a discussion of this new curriculum in an article by Dr. Christoph Ortland (Forschungsdock GmbH) und Dr. Ingo Rath (CliPS - Clinical Project Services^®) published in the scientific journal PM/QM (follow this link for the article which is available in German only). 

At CliPS we are currently preparing to add this update course to our 2021 training portfolio in order to continue to offer the full spectrum of investigator trainings for clinical trials with medicinal products in Germany. In case of any questions regarding this new update course or investigator trainings in general, please do not hesitate to contact us.