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You can search for organizations that are currently registered with the Clinical Trials Reporting Program by any of the following criteria:

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  • Organization Identifying Information
    • PO ID - Enter the exact PO ID only
    • CTEP ID - Enter all or part of the CTEP ID
    • Name - Enter all or part of the Organization's name
    • Family Name. Enter all or part of the Organization Family's name
  • Organization Address
    • Country - Select the country from the drop-down list
    • City - Enter all or part of the organization's primary location
    • State - Select the state from the drop-down list
    • Zip Code - Enter all or part of the Zip code

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    MultiExcerptNamesearchtrialquery

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    The Clinical Trials Reporting Office (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/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.

    The trials that match your search criteria are listed in search results tables. Which of the search results are displayed is determined by the following criteria:

    • Processing status of the trial at the time of the search. Trial statuses are listed and defined in Trial Processing Statuses.
      • Submitted - Original trial submitted but not validated
      • Amendment Submitted - Amendment submitted but not validated
      • Accepted - Trial passed validation
      • Rejected - Trial did not pass validation. These trials are not displayed.
      • Abstracted - Trial has been abstracted
      • Verification Pending - Trial has been abstracted, and the Trial Summary Report (TSR) has been sent 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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    Clinical Trials Search Results page
    To navigate the search results table, see Working with Tables and Search Results.

    Trial records returned from "Search My Trials" and "Search All Trials" options display the following details and actions you can take for each trial when applicable.

    Info

    No data are displayed for Private trials with a processing status of Rejected nor for Public trials with a processing status of Submitted or Rejected.

    The following table describes the columns in the search results table:

    Column

    Displayed for Public trials?

    Description

    NCI Trial Identifier

    Yes

    Unique identifier assigned to the trial by the CTRP

    Title

    Yes

    Official name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document)

    Lead Organization

    Yes

    Organization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trial

    Lead Org (Organization) Trial Identifier

    Yes

    Unique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.

    Principal Investigator

    Yes

    Appointed investigator responsible for conducting the clinical trial, or, for multi-site trials, the study chair

    ClinicalTrials.gov Identifier

    YesNumber assigned to the trial by PRS (ClinicalTrials.gov) (for trials that have been submitted to ClinicalTrials.gov previously)

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    Other Identifiers

    Yes

    Identifiers other than Lead Organization Trial Identifier or ClinicalTrials.gov Identifier

    Current Trial Status

    Yes

    Code that represents the status of a trial in relation to the ability to enroll participants/patients

    Current (Trial) Processing Status

    No

    Stage in the trial processing work flow

    Available Actions

    Yes

    Actions that are applicable to the trial according to the processing rules
    • Update - Link used to initiate trial updates
    • Amend - Link used to initiate trial amendments. Available for trials with processing statuses abstraction verified (response/no response).
    • Change Status - Link used to initiate a change to the trial status and status dates
    • Add My Site - Link used to initiate adding an organization as a participating site
    • Update My Site - Link available to Participating Site Record owners to initiate participating site information changes

    • Request TSR and XML documents (for complete trials) - Documents are sent via email to all trial owners

    • Verify Trial Data - Link used to verify open trial records twice per year to ensure that information is accurate and up-to-date

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      Note

      The actions available for a trial depend on its processing status and participating site record ownership.

    Accrual Disease TerminologyNo

    The disease terminology currently in use for accruals. You can select a new terminology from the drop-down list only if the trial has not accrued patients. Additionally, you can change accrual disease terminology at any time for trials currently recording accruals at the summary level only.

    (Participating) Sites

    Yes

    One or more organizations participating in the trial. Click View in the Sites column to view participating site details.

    Phase

    No

    Phase of the investigation, as defined by the US FDA for trials involving investigational new drug

    Primary Purpose

    No

    Main purpose of the trial

    Category

    No

    Data Table 4 Funding Sponsorship or Trial Submission Category

    Trial Start Date

    No

    Date on which the trial starts

    Responsible Party

    No

    Responsible party, as defined by FDAAA

    Sponsor

    No

    Primary organization that oversees the implementation of the study and is responsible for data analysis as defined in 21 CFR 50.3

    Data Table 4 Funding Sponsor Type

    No

    Trial category selected for trial submission

    Record Verification Date

    No

    Date on which the CTRO validated the trial submission

    Submitter

    No

    Name of person who submitted the trial

    Primary Completion Date

    No

    Date on which the trial reaches/reached its primary completion date

    Last Update Submitted

    No

    Date on which the trial was last updated

    Last Updater NameNoName of the person who last updated the trial

    Last Amendment Submitted

    No

    Date on which the trial was last amended

    Last Amender Name

    No

    Name of person who amended the trial

    On-Hold Reason

    No

    Reason why the trial was placed on hold

    Trial records returned from "Search Saved Drafts" display the following details and actions you can take for each trial when applicable:

    ColumnDescription
    Temporary Trial IdentifierUnique identifier that the system assigned to the saved draft
    TitleOfficial name of the protocol provided by the study principal investigator or sponsor (same as in the protocol document)
    Lead OrganizationOrganization responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of a given clinical trial
    Lead Organization Trial IdentifierUnique identification assigned to the protocol by the sponsoring organization. Multiple studies conducted under the same grant must each have a unique number
    Action
      • Complete - Link to initiate trial record completion
      • Delete - Link to initiate trial deletion
    Info

    Trial ownership and current processing status determine which of the trial details and actions listed above are displayed in the Search Results table. Refer to Trial Processing Statuses.

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