International Clinical Trials Registry Platform (ICTRP)

German Clinical Trials Register (DRKS)

Registry Profile

Websites

Governance

  • Funding Agency: Bundesministerium für Bildung und Forschung (Federal Ministry of Education and Research)

  • Managing Agency: University Medical Center Freiburg, Institute for Medical Biometry and Medical Informatics

  • Description:
    The German Clinical Trials Register is advised by a scientific guidance and advisory board with wide representation from a variety of stakeholders such as competent authorities, ethics committees, medical doctors and the pharmaceutical industry. The advisory board will meet once a year and will support the register in several ways. Its members will act as advocates and will help to enhance the acceptance of the German Clinical Trials Register.

Registry Criteria

  • Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
    Yes

  • Does the Registry have documented Standard Operating Procedures (SOPs)?
    Yes

    • Are mechanisms in place to ensure compliance with these SOPs? (eg staff training)
      Yes

    • Description of the compliance mechanisms:
      New staff members will undergo initial training. Every three months there will be retraining. Subsequently the SOPs are being adapted, expanded and reviewed. SOPs are assessed every two years by the Head of the Department.

  • Does the Registry agree to participate in the development of Guidelines for Clinical Trial Registries?
    Yes

  • Can the Registry collect and publicly display the WHO Trial Registration Data Set (TRDS)?
    Yes, Click here to view the details.

    • Languages in which the registered information is displayed:
      English, German

    • What quality control measures does your Registry have in place to make sure that all 20 items in the WHO TRDS are as complete and accurate as possible?
      A submitted trial will be initially checked manually and automatically for missing information and inconsistencies. Queries are then sent out to sponsors. In the future we will only accept trials for registration if all 20 WHO items are complete in English.

  • Does the Registry flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration?
    No

  • Does the Registry agree to submit the WHO Trial Registration Data Set, in English, to the Central Repository?
    Yes

  • Does the Registry agree to keep registered information up-to-date?
    Yes

  • Does the Registry agree to maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set can be tracked?
    Yes (to be available November 2008)

  • Does the Registry agree to never to remove a trial once it has been registered?
    Yes

  • Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
    Yes

  • Does the Registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a Collaborating Registry in the Registry Network?
    Yes

  • Is the Registry searchable over the Internet at no charge?
    Yes

  • Is the Registry open to all prospective registrants?
    Yes

  • From which countries will the Registry accept trials for registration?
    The Registry accepts trials of sponsors from all countries conducting trials in Germany.
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