Application for clinical drug trials

New application AMG

With effect from January 31, 2022, the Clinical Trial Regulation EU-536/2014 came into force in Europe. Since then, new, Europe-wide uniform regulations for clinical trials of medicinal products have been in force. Since January 31, 2023, new applications can only be submitted to the competent higher federal authority and the competent ethics committee in accordance with the new law and exclusively via the electronic information system for clinical trials of the European Medicines Agency (Clinical Trials Information System, CTIS).

From January 31, 2025 at the latest, all active clinical trials in the EU must comply with the new law. This means that clinical trials under the old law (Clinical Trial Directive 2001/20/EC) that are conducted in the EU after January 30, 2025 must be transferred to the Clinical Trials Regulation in good time. Applications for approval of such a so-called "transition" must be submitted via the Clinical Trials Information System (CTIS) in good time so that the approval procedure can be completed before January 31, 2025. Once the transition application has been approved, the new law will apply in full to this clinical trial.

Applications for the assessment of clinical trials (only if a trial site in the ethics committee's area of responsibility is subsequently registered) and subsequent amendments for applications already submitted via ethikPool (see below) can be submitted to the ethics committee via the online portal ethikPool (https://ekpool.ek-koeln.de). We ask you to submit the documents exclusively via the electronic application portal and to refrain from submitting them in paper form or by e-mail.

To help you submit an application for the evaluation of clinical trials of medicinal products, we provide you with "Instructions for submitting applications", where you will find all the basic information and procedural steps for submission via ethikPool.

When preparing applications in accordance with the AMG, please refer to the working documents and forms on thehomepageof the Working Group of Medical Ethics Committees in the Federal Republic of Germany.

With regard to the information on the qualifications of the members of the review group (see ''Proof of qualification for investigators, deputies and review body'' Section 3 and text examples), we recommend using the following table: Information on the qualifications of the members of the test group

Subsequent changes ("amendments")

All subsequent amendments to clinical drug trials submitted via ethikPool will be submitted via the portal. In addition, we request that all subsequent amendments to trials with application numbers 19-xxxx to 24-xxxx also be submitted in this way (even if you did not make the initial submission via ethikPool).

Detailed instructions can be found here.

Please note that, regardless of the type of amendment, a "(substantial) amendment" must be created in the ethikPool if the initial application was completed with a vote. Examples of processes that must be submitted via the "(substantial) amendment" function:

• Fulfillment of the conditions/additional provisions for a consultation/vote
• Significant changes to the content of the study
• structural changes (new test center, new examiners or deputies, changes to already assessed examiners or deputies)
• Information about the end of the study
• other changes / amendments
• Documents for information

We accept subsequent changes (amendments) to studies with application numbers 18-xxx and older by e-mail (ek-med@uni-koeln.de). Please submit your documents as an unencrypted and unpackaged PDF without password protection.

Assessing the qualifications of examiners and deputies and evaluating the selection criteria of medical members of an examination group

Note:

We would like to point out that for clinical trials conducted in accordance with EU Regulation 536/2014, the principal investigators, investigators and medical members of the trial team must provide evidence of appropriately updated regulatory knowledge. If participation in the basic or advanced course took place before 12.06.2020, proof of participation in an update course in accordance with the curriculum of the German Medical Association is required in addition to the basic or advanced course (see announcement of the German Medical Association. Dtsch Arztebl. 2022;119(19):A-888). Please note that a "refresher course" does not necessarily reflect the contents of this curriculum.

In 2016, the German Medical Association published curricula on basic, advanced, refresher and update courses for investigators, deputies and members of review groups on the recommendation of the Working Group of Medical Ethics Committees and the Standing Conference (see here).
In addition, the Working Group of Medical Ethics Committees and the German Medical Association have drawn up recommendations for assessing the qualifications of investigators and deputies and for assessing the selection criteria for medical members of a review panel:

https://www.aerzteblatt.de/pdf.asp?id=204780

As an announcement of the German Medical Association, this document is highly binding and forms the basis for the decisions of the ethics committees in accordance with Section 40 (1) No. 5 AMG in conjunction with Section 42 (1) No. 2 AMG.
To illustrate this, we have summarized the requirements in a diagram.
It should be noted that the required medical qualification is assessed independently of this. The assessment is carried out in each individual case against the background of the specific clinical trial.

Our sample protocol is available in English as a template for drawing up a protocol.

The Working Group of Medical Ethics Committees in Germany has adopted sample patient information and consent forms, which we also recommend as a template.

In accordance with legal regulations and resolutions of the Working Group of Medical Ethics Committees, we would like to draw your attention to the following points, which are not explicitly mentioned in the Working Group's checklist and are therefore sometimes overlooked when submitting applications:

1. Authorization to apply by the sponsor is required if the sponsor is not the applicant. If the University of Cologne is the sponsor, the UNI-LKP agreement must be enclosed (Section 14 (1) VwVfG).
2. For the assessment of the suitability of the local trial center in the area of responsibility of the Ethics Committee of the Medical Faculty of the University of Cologne, the following must be added to the application: Consent of the clinic director to conduct the study, if he/she is not appointed as head of the clinical trial or as investigator (Section 53 (1) sentence 3 HRG)
3. Proof that each investigator has been informed by a scientist responsible for the pharmacological-toxicological trial about its results and the risks likely to be associated with the clinical trial (Section 40 para. 1 no. 7 AMG). A corresponding declaration by the sponsor under point 4 of Module 2 [MS Word document, 78 KB at http://www.ak-med-ethik-komm.de] is suitable for this purpose.