Clinical trials; registration in the German Register of Clinical Trials

You can register your clinical trial in the German Clinical Trials Registry.

Description

The German Clinical Trials Registry (DRKS) is the primary registry for Germany recognized by the World Health Organization (WHO). It is responsible for all clinical trials that

  • conducted in Germany and are
  • are patient-oriented.

The aim of the registry is to provide the public with a complete and up-to-date overview of clinical trials in Germany. It contains more than 12,000 studies. Currently, about 2000 are added annually.
The DRKS not only serves as a source of information for patients. It also supports professionals in planning clinical trials. For example, it helps to avoid duplicate studies. The DRKS enables,

  • to search for information on ongoing and completed clinical trials in Germany or to
  • to make your own studies accessible.

You are responsible for registration as the sponsor or as the head of the clinical trial of a study.
In Germany, you are not legally required to register all studies. However, physicians who are responsible for studies are indirectly required to register under their professional regulations. In addition, various bodies require registration, for example for a

  • Funding: groups and organizations such as the Federal Ministry of Education and Research or the German Research Foundation (DFG)
  • Publication: medical journals.

The DRKS does not accept studies with the following criteria:

  • no clear clinical reference
  • animal experiments
  • pure research on tissue without informed consent of the participants and signed consent to participate in this study. Exception: COVID studies
  • reviews and meta-analyses
  • pure data collection from patients without clear clinical reference

You cannot delete a study registered in the DRKS there.

Prerequisites

formal criteria:

  • Vote of an ethics committee
  • Individual studies

other criteria:

  • Study on humans or on dummies (training manikins). Studies on dummies can be registered in the DRKS, since in this case the object of the study is the medical personnel who are to learn something.
  • health-related questions such as disease treatment, therapy monitoring or investigation of risk factors
  • interventional studies, for example medication, surgery, radiation, talks, physiotherapy, vaccinations
  • non-interventional studies, for example observational studies, prognosis studies
  • Training studies, for example, in which persons receive training whose effect is to be tested. The trained persons should directly treat patients themselves (e.g. studies on physicians, nurses or first aiders).

Procedure

To register your study in DRKS, you must use its online portal:

  • Register once, if necessary.
  • Log in to the DRKS online portal with your access data.
  • Follow the navigation to register your study.
  • Each study will be checked for plausibility and completeness.
  • Provided there are no queries from data management, the study will be registered in the DRKS online portal.
    • If not, the person responsible for the study will be asked to rework the study.
  • You will receive confirmation of the registration by e-mail.

Deadlines

You may need to observe deadlines in connection with funding or publication of your study in journals. The latter requires registration before the planned start of recruitment of the subjects, so you should apply for registration at least 3 weeks before.

Processing time

usually no more than 2 to 3 working days

Required documents

  • Required Documents

    Sie müssen keine Unterlagen einreichen.

Online procedures

Fees

  • There are no costs for you.

Legal bases

Remedy

Until the registration is completed, you can withdraw your application.

Links to more information

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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