Clinical trials; registration in the German Register of Clinical Trials

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

Description

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 document/s

    You do not need to submit any documents.

Online procedures

Fees

  • There are no costs for you.

Remedy

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

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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