International Clinical Trials Registry Platform (ICTRP)

Clinical Trials Registry - India (CTRI)

Registry Profile

Websites

Governance

  • Funding Agency: India Department of Science and Technology (DST); Indian Council of Medical Research (ICMR); World Health Organization (WHO)

  • Managing Agency: National Institute of Medical Statistics (NIMS)

  • Description:
    The Registry has a steering committee and a Technical Working Group (TWG). The steering committee is for policy decision-making authority and TWG is the decision making group for all technical and software development issues.

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, under development

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

    • Description of the compliance mechanisms:
      Under development.

  • 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

    • 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?
      Initially, two scientists will do manually. Later on, it will be done electronically.

  • Does the Registry flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration?
    Yes

  • 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

  • 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?
    Initially, India. Later on, it will be scaled up to cover neighbouring countries.
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