BfArM - Federal Institute for Drugs and Medical Devices

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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 …

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

The goals of the DRKS can be found in our "About Us" section.

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 …

Does the DRKS meet ICMJE criteria? Date: 28. October 2021 Topics: About BfArM Type: FAQ

Yes. The ICMJE accepts registration in all primary registries and data provider registries of the WHO network. The DRKS has been recognised by the WHO as a primary register for Germany since October 2008 and thus fulfils the requirements of the ICMJE

Can a study once registered in the DRKS be deleted from the register? Date: 28. October 2021 Topics: About BfArM Type: FAQ

No. The DRKS is the primary registry for Germany recognised by the WHO and is bound by the WHO's international standards for clinical trial registries. It stipulates in section 1.5 that once a study has been registered, it may never be deleted.

WHO

Locations of the Federal Institute for Drugs and Medical Devices Date: 13. July 2021 Topics: About BfArM Type: Article

Locations of the Federal Institute for Drugs and Medical Devices

#bfarmDigitalFuture PDF, 6MB, File is accessible Date: 10. March 2021 Topics: About BfArM Type: Download

Shaping health together: The BfArM as a partner in Germany and Europe.

Digital Future Date: 19. February 2021 Topics: About BfArM Type: Article

Shaping health together: The BfArM as a partner in Germany and Europe.