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Networking Date: 28. October 2021 Topics: About BfArM Type: Article

Networking

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).

Why should a study be registered with the DRKS? Date: 28. October 2021 Topics: About BfArM Type: FAQ

The DRKS is the only study registry for Germany recognised by the WHO and collects study data in German and English. Patients and other interested laypersons can better use and understand entries in their national language. Information provided in …

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

Clinical trial registries increase the transparency in clinical research because they provide public access to trial data. They serve as a source of information for patients and support the expert audience in the planning of clinical trials e.g. by …