Other studies

How is the responsible ethics committee determined?
The “responsible ethics committee” is the ethics committee responsible for the head of the clinical trial (overall trial management).

As the overall trial manager, the head of the clinical trial is the central figure in a multicenter trial project. He or she is responsible not only scientifically, but also ethically and legally for the conduct of the trial. The principal investigator submits the application dossier to the competent ethics committee. The committee reviews the study and issues its vote.

a) Once the vote of the responsible ethics committee has been received, the local study centers submit their notification dossier to the local ethics committees. The submission is usually made by the local study director.

b) Possible scenarios after submission of the notification dossier:

• If the local ethics committee is already able to participate in the “1 study – 1 vote” procedure, it confirms receipt of the notification dossier – the study can begin at this center.
   
• If the legal requirements are not yet met at a site, the local ethics committee will ask the study physician concerned to submit the application dossier previously submitted to the responsible ethics committee instead of the notification dossier.

You will need the application dossier for your initial application to the responsible ethics committee. This is the ethics committee at the site where the principal investigator is based.

Application form:
The application form is essential for your initial application to the responsible ethics committee.

The following documents, listed below, must always be submitted in addition to the application form.

Study protocol:
– To draw up the study protocol, select the version applicable to your study from
versions A, B, C, D or E of the study protocols.
– When submitting the study protocol for prospective studies (version A), a structured synopsis must be provided.

• Application form
• Study protocol, Variant A – Prospective
  • This also includes non-interventional studies (NIS) in which the therapeutic or diagnostic measures are not the subject of the study but form part of standard clinical care.
• Study Protocol Variant B – Biobank
• Study Protocol Variant C – Register
• Study Protocol Variant D – Retrospective
• Study Protocol Variant E - Qualitative Study
• Structured Synopsis
• Declaration of the study centre’s suitability
• Details of funding and declaration of cost coverage

You must also submit a list of the local participating study centres, including the doctors responsible at each site (see guidelines).

2.) You may need to submit further additional documents, if applicable to your research project. A list of possible additional documents to be submitted can be found in the application form under section C2.

You will need the notification dossier if you wish to submit an initial application to a local ethics committee.

Please submit the following documents to
your local ethics committee:

Notification to the local ethics committee

Declaration of the study site's eligibility
 

The following must also be submitted:

• Structured Synopsis based on study protocol Variant A or a short application
• List of participating study centers, including the responsible physicians
• Vote of the competent ethics committee
• Billing address
• Information on financing and a declaration of cost coverage 

You should submit the amendment if changes are made to a research project that is already underway.

Please submit the following documents to your ethics committee:

Amendment

Declaration of the study site's eligibility

If there are changes to the study centers,
please also submit the form for Declaration of the study site's eligibility.

Please note the requirements for a (purely) retrospective research project:

• All (health) data to be used are already available (retrospective data analysis)

Note: If you conduct analyses on existing samples, the project is no longer considered retrospective but rather a prospective research project (see below).

• The data are routinely collected at your own clinic or department
• No additional study-related interviews or examinations will be conducted
• So-called “third parties” will not have access to the data
• Data sharing and publication will take place exclusively in anonymous form

If the requirements above are met, the following documents must be submitted:

• Cover letter in German (signed)
• Study protocol, abstract, or manuscript for publication
• Studienprotokoll Variante D_Retrospektiv

Please submit the application via https://ekpool.ek-koeln.de. You can find detailed instructions on how to submit a report via ethikPool here.
All documents must be uploaded in PDF or XML format; Word or Excel files cannot be uploaded for security reasons.

If a research project involves the use of biomaterial, please note the following: The use of biomaterial generates new data, and the project is not a purely retrospective research project. Such applications must be submitted as “Variante A: Prospektiv”.

If a CE-certified medical device is used in a clinical trial in accordance with its intended use and the trial participants are not subjected to any additional invasive or otherwise burdensome procedures, the Medical Devices Implementation Act (MPDG) does not apply.

These studies then fall under the category of “Other Studies” and are subject to professional regulatory guidance. The AKEK has developed a checklist for this type of study („Checkliste der einzureichenden Unterlagen bei PMCF-Studien innerhalb der Zweckbestimmung und ohne invasive oder belastende Verfahren“). In addition, the AKEK has adopted a document in this context listing examples of “zusätzlich invasiven oder anderen belastenden Untersuchungen”. The document was developed while Section 23b of the Medical Devices Act (MPG) was still in effect, but it remains valid.

You can find both documents here:

Checkliste der einzureichenden Unterlagen bei PMCF-Studien innerhalb der Zweckbestimmung und ohne invasive oder belastende Verfahren

Zusätzliche invasive oder andere belastende Untersuchungen gemäß § 23b MPG

Effective July 1, 2025:

All research projects involving study-related radiation exposure are subject to approval under professional regulations (see figure).

This means the following procedure applies when submitting applications for multicenter studies (“1 Study – 1 Vote”):

1. Submission to your competent ethics committee:
Submit the AKEK application form and, if applicable, the study protocol (Variant A). In the study protocol (Variant A), Section 8 on radiation protection has been updated as of July 1, 2025, in accordance with the provisions of the Medical Research Act.

2. Submission to the Federal Office for Radiation Protection (BfS):
Submit the documents required by the BfS, along with the existing ethics approval issued for your study, to the BfS. Please use the forms available on the Federal Office for Radiation Protection (BfS) website for your submission.

The principle of “one study – one vote” will also apply to amendments to studies that received their initial vote before June 2024. The change will take effect immediately, where legally possible at the local level.
The commission responsible for advising on the amendment will also check whether the content of the AKEK documents agreed upon for harmonization since June 2024 has been observed and will reprimand any deficiencies.

The first substantive amendment automatically triggers the switch to “one study – one vote.”  The switch must be made, but only when a change to a research project is submitted. In particular, the switch must be made when a study center is registered retrospectively!
It must also be made when switching from a single-center to a multicenter study if the procedure was not used for single-center studies.
If no change is made, no change is necessary.
The former initial ethics committee becomes the responsible ethics committee and issues a vote.
This vote is accepted by the local ethics committees in the context of a notification. No special measures are required on the part of the local ethics committees – amendments can be notified according to the “one study – one vote” procedure (if necessary).

Documents that did not exist prior to harmonization may need to be requested. These include:

▪ Structured synopsis (study protocol A only)
▪ List of all study centers in Germany
▪ Declaration of suitability of study centers for new trial centers only

• Study protocol
  • Does the protocol still meet the current minimum requirements according to checklists A-D?
  • Does any information on the legal basis need to be adjusted?
• Information documents
  • Do the information documents comply with current requirements (based on the eTIC tool)?
  • Is the information on data protection still up to date?
  • Are all the necessary information documents available (children, adolescents, adults, legal guardians, etc.)?

• The role of the responsible commission can only be performed by a German commission formed in accordance with state law.
• If the overall study management is based abroad, a German overall study management must be designated for the submission.
  • This must be mentioned at least in the structured synopsis.
• The commission responsible for the overall study management in Germany is the responsible commission within the meaning of the “One study - one vote” procedure.