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Is it allowed to register my trial in DRKS if it is already registered in another WHO Primary Registry (e.g. CTIS)? Date: 07. April 2025 Topics: About BfArM Type: FAQ

WHO recommends that clinical trials with one or more recruitment sites in the same country should be registered in only one study registry. For more information, please visit the WHO website.

If you still wish to register in the DRKS (e.g. because …

What is ICMJE? Date: 15. February 2023 Topics: About BfArM Type: FAQ

The International Committee of Medical Journal Editors (ICMJE) is a union of the publishers of leading international medical journals which set guidelines for the publication of clinical trials. The ICMJE includes journals like JAMA, New England …

Which trials can/should be registered with the DRKS? Date: 03. February 2023 Topics: About BfArM Type: FAQ

Formal criteria:

  • the existence of a positive vote by an Ethics Committee of the European Union or Switzerland in German or English. Votes in other languages require an official translation in addition.

Additional criteria:

  • study on humans
  • health …

Which documents are mandatory to upload for the registration of my study? Date: 28. October 2021 Topics: About BfArM Type: FAQ

A study cannot be registered without a positive vote by an ethics committee. This must be submitted in German or English.

If the vote is not in German or English, an official translation must be included.

My study has just been registered, but I can't find it. Date: 28. October 2021 Topics: About BfArM Type: FAQ

The SearchTool is updated every night. You can access your study directly after registration via the direct link (www.drks.de/DRKS000XXXXX) or find it via the Search Tool as of the next day.

In which other registries are studies conducted in Germany registered? Date: 28. October 2021 Topics: About BfArM Type: FAQ

In addition to the DRKS, there are two other registries that contain a significant number of studies conducted in Germany. Their studies are mostly not included in the DRKS (see FAQ below).

  • EU-CTR/CTIS: Approximately 600 phase II-IV drug trials (as …

Is my clinical trial an IST/IIT? Date: 28. October 2021 Topics: About BfArM Type: FAQ

IST/IIT stands for investigator sponsored trial/investigator initiated trial. The responsibility for initiation and organisation of such a study (the sponsorship) rests with the respective individual or the institution to which this person belongs (

When should clinical trials be registered? Date: 28. October 2021 Topics: About BfArM Type: FAQ

In order to register a trial according to ICMJE standards, it has to be registered in a registry accepted by the ICMJE before recruiting the first participant (=prospective registration). A participant is considered as recruited as soon as the …

Is it possible to register trials which are already ongoing or finished (retrospective registration)? Date: 28. October 2021 Topics: About BfArM Type: FAQ

Yes, you can also register ongoing and finished trials. However, this retrospective registration does not meet the standards of ICMJE and might not be accepted by all journals. Retrospectively registered trials are clearly marked as such in the DRKS.

Who is responsible for the registration of a clinical trial? Date: 28. October 2021 Topics: About BfArM Type: FAQ

The sponsor is responsible for the registration. The task can, however, also be delegated (e.g. to the Principle Investigator/ Lead Principle Investigator).