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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 …