International Clinical Trials Registry Platform (ICTRP)

German Clinical Trials Register (GermanCTR)

Deutsches Register Klinischer Studien (DRKS)

Registry Profile

General Information

Content

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

  • 2. Is the Registry open to all prospective registrants (ICMJE), either internationally, or within one or more specific countries?
    Yes

    • 2.1. From which countries will the Registry accept trials for registration?
      All countries

    • 2.2. If the Registry is not open to ALL registrants (that is, accepts trials only from a particular sponsor, health care condition (eg cancer), intervention, etc) please specify which trials the Registry is open to.
      Not applicable

  • 3. Is the Registry able to collect and publicly display the WHO Trial Registration Data Set? (ICMJE)
    Yes

  • 4. Does the Registry endeavour to keep registered information up-to-date?
    Yes

    • 4.1. Does the Registry have a reminder system to facilitate the submission of updated information by the responsible registrant?
      Yes

    • 4.2. Does the Registry highlight or flag records that are not current (have not been updated in more than 12 months) so readers are aware that information contained in such records may not be current?
      No

  • 5. Does the Registry never remove a trial once it has been registered?
    Yes

Quality and Validity

  • 6. Does the Registry have a mechanism in place to ensure the validity of the registered data? (ICMJE)
    Yes

    • 6.1. Does the registry contact Responsible Registrants when one or more items in the Trial Registration Data Set are incomplete or potentially inaccurate?
      Yes

    • 6.2. Does the registry have documented Standard Operating Procedures (SOPs)?
      Yes

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

    • 6.4. Please briefly describe these compliance mechanisms.
      Training for new register staff, regular team meetings, defined procedures to develop and implement new SOPs. SOPs are part of a QM-System that is in use in the whole department/ institute. The quality management of the registry is embadded in the QM system of the ISO certified Institute and all actions regarding SOP training, actualisation and (re)writing of SOPs are performed according to the ISO system.

  • 7. Does the registry maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set for an individual trial can be tracked?
    No

  • 8. It is desirable that Primary Registries participate in the development of the International Standards for Clinical Trial Registries. Does the Registry agree to participate in the development of these standards?
    Yes

Accessibility

  • 9. Is the WHO Trial Registration Data Set accessible to the public at no charge? (ICMJE)
    Yes

  • 10. Is the WHO Trial Registration Data Set electronically searchable? (ICMJE)
    Yes

  • 11. Is the WHO Trial Registration Data Set available in English?
    Yes

  • 12. Can registrants submit a trial for registration at any time of day on any day of the week (24 hours a day, seven days a week)?
    Yes

  • 13. Can the register be searched at any time of day on any day of the week (24 hours a day, seven days a week)?
    Yes

  • 14. It is desirable that the WHO Trial Registration Data Set be available in the language/s of the countries served by the registry. Please indicate the languages in which the registered information is displayed.
    English and German

    • 14.1. If trials are registered in more than one language, does the registry check the quality of translation?
      Yes

  • 15. What quality control measures does the registry have in place to make sure that all items in the WHO Trial Registration Data Set are as complete and accurate as possible?
    A lot of single and cross checks are made to check manually and automatically the plausibility and the completeness of data. Data is cleared via a query-system between registry and registrant.

Unambiguous Identification

  • 16. Does the Registry have processes in place to prevent the registration of a single trial more than once on their register?
    Yes

    • 16.1. Please briefly describe these processes.
      With our new software duplicates will be checked automatically. Up to now manual checks are made, secondary IDs are checked.

  • 17. Does the Registry agree to facilitate the retrospective linking (or bridging) on the WHO Search Portal of a single trial registered with more than one registry by encouraging Responsible Registrants to enter secondary identifiers, including the UTN?
    Yes

  • 18. Does the Registry agree, as part of the registration process, to search the WHO Search Portal to ascertain if the trial has already been registered on another WHO Primary Registry?
    Yes, we agree, but not as a task of the primary registries, this must be done by the sponsor. We ask all registrants to confirm that they have checked the ICTRP search portal to see if trial registration records for this trial already exist.

Technical Capacity

  • 19. Does the Registry agree to submit the WHO Trial Registration Data Set for all records on their registry to the Central Repository?
    Yes

    • 19.1. Is the registry regularly submitting data to the ICTRP?
      Yes

  • 20. Does the Registry have access to a database that is used to store and manage the submitted data?
    Yes

    • 20.1. If not, please provide details of the database that will be used and where it is based.
      Not applicable

  • 21. Does the Registry have access to adequate information technology support?
    Yes

  • 22. Does the Registry have adequate security and other provisions against data corruption/loss?
    Yes

Administration and Governance

  • 23. Does the Registry have at least a national remit?
    Yes

    • 23.1. From which countries does the Registry have the remit to act as their Primary Registry?
      Germany

  • 24. Does the Registry have a letter of support from the relevant Ministry of Health or other agency?
    Yes

    • 24.1. Please specify the names of the government agencies that have given their support.
      Federal Ministry of Education and Research

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

  • 26. Is the Registry managed by a not-for-profit agency? (ICMJE)
    Yes

  • 27. Should the register cease to function, does the register agree that at least the WHO Trial Registration Data Set for all trial records will be transferred to a WHO Primary Register?
    Yes

    • 27.1. Does the registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a WHO Primary Registry?
      Yes

  • 28. It is desirable that Primary Registries have a strategy in place addressing the medium to long term sustainability of the registry. Does the Registry have such a strategy in place?
    Yes

  • 29. Other Governance information:

    • 29.1. What is the name of the agency (or agencies) that fund the registry?
      Federal Ministry of Education and Research

    • 29.2. What is the name of the agency that manages the registry?
      University Medical Center Freiburg, Institute of Medical Biometry and Medical Informatics

    • 29.3. Is the agency that manages the registry a for-profit agency?
      No

    • 29.4. If the agency is for-profit, is the data on the register (database) also available on a Registry that is managed by a not-for-profit agency?
      Not applicable

    • 29.5. If the answer to 29.4 is "yes", then please specify the name of the additional Registry.
      Not applicable

    • 29.6. Please describe any other ownership or governance issues of relevance to the register. (eg Does the register have an Advisory Board. If so, what is its role?
      The GermanCTR does have and Guidance and Advisory Board (GAB) representing all stakeholders, the competent authorities, the Federal Ministry of Health and the Federal Ministry of Education and Research. This Board meets annually and is additionally contacted if necessary. Role of the GAB is to advise and to support the work of the German CTR in all scientific and technical issues and help to initiate and foster the important cooperation with ethics committees, partner registries and the scientific community.
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