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The search results table lists the trials that match your search criteria, as well as additional criteria, including a trial processing status. This status reflects the work of the Clinical Trials Reporting Office (CTRO). The CTRO reviews each trial submitted to the system in order to validate submitted information. During the validation process, the reviewers check for duplicate records and ensure that the submitter has provided all required information. CTRO does one of the following as part of the validation /process, before abstraction process:

  • If all data is complete and accurate, the reviewers assign the trial the status "Accepted," and the system notifies the submitter by email.
  • If information is missing, or there are discrepancies in the information provided, the reviewers can place a trial on hold. The CTRO contacts the submitter for clarification and/or to request missing documents, and resumes processing once the trial is validated.
  • If the trial is a duplicate (i.e., another user has submitted the same trial), the reviewers assign the trial the status "Rejected," and the system sends the submitter an email message indicating the status and reason for the rejection. Reviewers may also reject a trial if CTEP/DCP/CCR has approved the trial. NCI transfers these trials internally.
Info

If you have questions about a rejected trial, contact the CTRO at ncictro@mail.nih.gov. For more information about this process, refer to Typical Life Cycle of a Trial and Amendment Process Life Cycle.

The search results table lists the trials that match your search criteria, as well as the following criteria:

  • Processing status of the trial at the time of the search. For a definition of each status, refer to Trial Processing Statuses.
    • Submitted - Original Submitter has registered original trial submitted but CTRO has not validated it yet.
    • Amendment Submitted - Amendment Submitter has submitted amendment but CTRO has not validated it yet.
    • Accepted - Trial has passed validation.
    • Rejected - Trial did not pass validation. The search results table does not list these trials.
    • Abstracted - CTRO has abstracted the trial.
    • Verification Pending - CTRO has abstracted the trial and has sent the Trial Summary Report (TSR) to the trial submitter for abstraction verification.
    • Abstraction Verified Response - Submitter has verified the abstraction as per the TSR, and has returned feedback to the CTRO within five business days after receiving the TSR.
    • Abstraction Verified No Response - Submitter has not responded or returned verification feedback to the CTRO within five business days after receiving the TSR.
  • User's role with respect to the trial. User roles include the following:
    • Site Administrator - Has full access to the trials led by the organization (plays lead organization role).
    • Trial Submitter/Owner - Has full access to the trials they own or submitted.
    • Other user - Any user other than the trial submitter, owner, or trial's lead organization system administrator.
  • Trial ownership. Trial ownership types are as follows:
    • Private trials - Trials submitted or owned by the user who is currently logged in to Registration.
    • Public trials - Trials submitted by other registered users.

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Business Day Definition - Include v4.4
Business Day Definition - Include v4.4

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