International Clinical Trials Registry Platform (ICTRP)

Japan Primary Registries Network (JPRN)

臨床研究〔試験〕情報検索

Registry Profile

JPRN Framework

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?
      UMIN CTR: Yes
      JapicCTI: No
      JMACCT CTR: No, currently not, but will be able to by the end of March 2010. Those records that have been left un-updated for more than a year will be displayed with an asterisk.

  • 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.
      UMIN CTR: (1) Staff training. (2) The staffs in charge of UMIN CTR report the data check results and entry statistics in our weekly staff meeting.

      JapicCTI: After the JapicCTI staff (pharmacist) checks the content of registration, the system sends mail to the registrant to confirm the content again. The registrant confirms the content, and pushes the button of opening to the public voluntarily.

      JMACCT CTR: Staff training to enhance the understanding of SOPs

  • 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?
    Yes

  • 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.
    UMIN CTR: English (essential) and Japanese (not essential, but the most registrants entered)
    JapicCTI: Japanese and English
    JMACCT CTR: Japanese and English

    • 14.1. If trials are registered in more than one language, does the registry check the quality of translation?
      UMIN CTR: (1) Our assistant professor checks all new records every week, and, if necessary, ask registrants to correct or add item data. (2) Every six months, we send confirmation mail to both research groups and the ethical committees of their chief investigators' institutions in order to confirm and update registered information.

      JapicCTI: Trials are submitted in both Japanese and English by the Responsible Registrant. The JapicCTI staff checks the translation only for obvious errors and discrepancies. JapicCTI does not provide any assurance of the quality of translation.

      JMACCT CTR: Trials are submitted in both Japanese and English by the Responsible Registrant. The JMACCT staff check the translation only for obvious errors and discrepancies. JMACCT CTR does not provide any assurance of the quality of translation.

  • 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?
    UMIN CTR: English (essential) and Japanese (not essential, but the most registrants entered)

    JapicCTI: Registered information is verified by the JapicCTI staff and if necessary, ask registrant to correct. Every 1 year, JapicCTI system sends confirmation mail to registrant in order to confirm and update registered information from this spring.

    JMACCT CTR: If any of the items in the WHO Trial Registration Data Set is not provided on the protocol data entry page on our registry, a message box appears to alert the registrant about the incomplete entry. To prevent incorrect entries, a list of choices, such as a dropdown list, is provided where possible. Registered information is verified by staff and the registrant is contacted if additional information or clarifications are needed.

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.
      UMIN CTR: Every week, our assistant professor checks all new records, and, if the same or similar trials are found, he confirms the they are the same or not.

      JapicCTI: Each submitted trial is checked for duplication within JapicCTI database before it is accepted for registration.

      JMACCT CTR: Each submitted trial is checked for duplication within JMACCT CTR database before it is accepted for registration.

  • 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

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?
      Japan

  • 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.
      Ministry of Health, Labour and Welfare

  • 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?
      UMIN CTR: The University of Tokyo (National University Corporation), funded by the Ministry of Education, Culture, Sports, Science and Technology, Japan
      JapicCTI: JAPIC (Japan Pharmaceutical Information Center)
      JMACCT CTR: Japan Medical Association

    • 29.2. What is the name of the agency that manages the registry?
      UMIN CTR: National University Hospital Council of Japan
      JapicCTI: JAPIC (Japan Pharmaceutical Information Center)
      JMACCT CTR: Japan Medical Association Center for Clinical Trials

    • 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?
      UMIN CTR: Under the National University Hospital Council of Japan, there is University Hospital Medical Information Network (UMIN) Committee. The UMIN committee functions as an advisory board for UMIN, including UMIN Clinical Trial Registry.
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