International Clinical Trials Registry Platform (ICTRP)

Clinical Trials Registry-India (CTRI)

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?
      No

    • 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, it will be done in Phase II.

  • 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)?
      No

    • 6.3. Are mechanisms in place to ensure compliance with these SOPs (eg staff training)?
      Not applicable

    • 6.4. Please briefly describe these compliance mechanisms.
      Not applicable

  • 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?
    Not applicable

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

    • 14.1. If trials are registered in more than one language, does the registry check the quality of translation?
      Not applicable

  • 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?
    Manual Scrunity, verification at 2 levels of all submitted trials prior to registration. The trials are registetred after obtaining the EC/DCGI document and their verification with respect to tiltle and PI’s name or for any other discrepancy with the submitted information.

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.
      Electronic deduplication process is inbuilt. Duplicate for trials is also seen by manual verification with title and drug combination.

  • 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?
      India

  • 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.
      MOHFW and DCGI (Drug Controller General of India)

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

    • 25.1. Please indicate the web address where this information is displayed.
      http://www.ctri.in

  • 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?
      DST, WHO, ICMR

    • 29.2. What is the name of the agency that manages the registry?
      National Institute of Medical Statistics, ICMR

    • 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?
      Yes, the role of advisory board is to take policy decision.
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