Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC went into force on 31 January 2022.

With the entry into force of this regulation, the manner of the submission, implementation and evaluation of clinical studies has significantly changed. This also has an impact on the submission of applications for the evaluation of clinical investigations by the Ethics Committee, which now occurs centrally through the Clinical Trials Information System – in brief CTIS. More detailed information may be found on the websites of the European Medicines Agency (EMA), of the Federal Institute for Drugs and Medical Devices (BfArM) and of the Paul-Ehrlich-Institut.

Documents required to submit clinical trials to the Ethics Committee according to CTR

Sample texts and recommendations regarding informed consent documents

The Association of Medical Ethics Committees (AKEK) provides current sample texts on its website that may be downloaded.  

Qualifications of the investigators / team of investigators

The Association of Medical Ethics Committees provides templates and recommendations on its website.

Curricular advanced training courses and recommendations of the German Medical Association and the Association of Medical Ethics Committees.