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Head Date: 23. August 2022 Topics: About BfArM Type: Article

Head

Antragsformular/Application Form for a kick-off meeting by the Innovation Office PDF, 204KB, File does not meet accessibility standards Date: 05. July 2022 Topics: About BfArM Type: Download

Application Form for a kick-off meeting by the Innovation Office

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.

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 (

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 …

Where do I find studies which were imported from ClinicalTrials.gov until 2017? Date: 28. October 2021 Topics: About BfArM Type: FAQ

Studies automatically imported from ClinicalTrials.gov until June 30, 2017, were removed from the database with the transition to the new DRKS application at the end of 2022. Duplicate registration in multiple WHO primary registries is not desired by

Where is it possible to register systematic reviews? Date: 28. October 2021 Topics: About BfArM Type: FAQ

The "International Prospective Register for Systematic Reviews PROSPERO" is open for free registration to anyone undertaking a systematic review with a health-related outcome.

Article on the subject: Best Practice in Systematic Reviews: The …

The activation link/password reset does not work. Date: 28. October 2021 Topics: About BfArM Type: FAQ

If the activation link for you account does not work or if you are not able to reset your password please contact the technical helpdesk of the BfArM (helpdesk-technik@bfarm.de).

Is there a fee for the use of the register or the registration? Date: 28. October 2021 Topics: About BfArM Type: FAQ

No. Both registration and searching for trials is free.

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).

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.

Is it allowed to register my trial in DRKS if it is already registered in another WHO Primary Registry (e.g. EudraCT/EU-CTR)? Date: 28. October 2021 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.
If there are several recruitment sites in different countries, the trial can be registered in more than one …

What are the advantages of the DRKS? Date: 28. October 2021 Topics: About BfArM Type: FAQ

  • Registration of trials and searching the registry is free of charge.
  • The contents of the homepage are provided in English and German.
  • The input mask has been designed to be very user-friendly.
  • When entering parameters, catalogs and internationally used …

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 …

May I register my study in DRKS if it has already been registered in CTIS? Date: 28. October 2021 Topics: About BfArM Type: FAQ

CTIS has been an official "Data Provider" of the ICTRP registry of the WHO since June 2023 and is thus recognised by the ICMJE equivalent to ClinicalTrials.gov. Studies from CTIS should therefore only be registered in the DRKS with appropriate …

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.

What is the DRKS? Date: 28. October 2021 Topics: About BfArM Type: FAQ

The German Clinical Trials Registry (DRKS) is the WHO-recognised primary registry for Germany and, along with CTIS, is responsible for the registration of patient-oriented clinical trials conducted in Germany. Further information can be found on the