You can find the guideline and a note on the AKEK website published under Examiner qualification - Curricular training - AKEK - Working Group of Medical Ethics Committees

The Executive Board of the German Medical Association has decided that the curricular training courses in the version dated 16.09.2016 (published in Dtsch Ärztebl 113; Heft 40 [07.10.2016]: A-1780 / B-1500 / C-1492) are obsolete.

• The course content is based on the curricula published by the BÄK [1, 2, 3].
• The course content (table of contents) and the reference to the respective BÄK curriculum should be noted on the certificate.
• A learning success check is provided for in the curriculum; this should be noted on the certificate (ideally with details of the scope).
• For online courses, the BÄK's "eLearning quality criteria" [4] should be observed. These are fulfilled, for example, by CME certification. If there is no CME recognition, the above criteria are decisive for the evaluation by the EC. The BÄK recommends face-to-face teaching at least for the course content to be practiced and the learning success control, but the EC of the MHH does not follow this without exception.
• The course content must deal with national/EU legal issues; only GCP content is not sufficient. This must be observed for international providers and in particular for online courses from international providers.

[1] German Medical Association (2021). Basic course for investigators/deputy investigators and medical members of an investigation team in clinical trials under the Medicinal Products Act including principal investigators and investigators under Regulation (EU) No. 536/2014 and the Medical Devices Act or Regulation (EU) No. 2017/745 and the Medical Devices Implementation Act (DOI: 10.3238/arztbl.2021.Grundlagenkurs_AMG_MPG_2021)

[2] German Medical Association (2021). Advanced course for investigators/deputy investigators or principal investigators who lead an investigator group or investigator team/investigator team in clinical trials according to the Medicinal Products Act or Regulation (EU) No. 536/2014 or according to the Medical Devices Act or Regulation (EU) No. 2017/745 and the Medical Devices Implementation Act (DOI: 10.3238/arztbl.2021.Aufbaukurs_AMG_MPG_2021)

[3] Bundesärztekammer (2021). Refresher course for investigators/deputy investigators and medical members of an investigation team in clinical trials under the Medicinal Products Act, including for principal investigators and investigators under Regulation (EU) No. 536/2014 and the Medical Devices Act or Regulation (EU) No. 2017/745 and the Medical Devices Implementation Act (DOI: 10.3238/arztbl.2021.Auffrischungskurs_AMG_MPG_2021)

[4] Bundesärztekammer (2013). Quality criteria eLearning of the German Medical Association - Criteria catalog. Link: http://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/KritELearningV9.pdf (06.06.2017)

• Current, dated, signed curriculum vitae on medical training and professional activity (extensive publication lists should be omitted).
• AMG/MPG/GCP training certificates in accordance with the criteria described under "2. Quality requirements for the courses and their certificates".
• Proof of study experience (table with EudraCT numbers, indications, duration and role of the applicant in the respective study).
• Special feature for the head of the clinical trial (LKP) or the investigator in monocentric studies: Proof of at least 2 years' experience in conducting clinical trials.
• Proof of financial independence from the sponsor (usually on the sponsor's form).

• The Ethics Committee requires that all studies, regardless of the regulatory context, are based on GCP principles or that researchers provide evidence of appropriate training or certification.
• At least for the principal investigator, proof of participation in a basic GCP course no older than 2016 must be provided.