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This page provides an overview of the new and updated data elements in CTRP for the FDAAA Final Rule. NCI has been implementing changes in the following areas of CTRP in support of the FDAAA Final Rule and ClinicalTrials.gov reporting:changes in CTRP:

September 2020

  • CTRP Trial Record Verification: Improved the user experience for CTRP trial owners, trial submitters and site administrators with Verifying, Updating and/or Amending their trial records. Key highlights from this enhancement include:
    1. New page highlighting all Trials Needing Verification
    2. Ability to view all trial details on the Verify screen
    3. Simplified workflow allowing users to Verify, Update or Amend trials within same form
    4. New monthly email notification for alerting trial owners, trial submitters,
      and site administrators of Trials Needing Verification
  1. Phase 1 - In May 2017, NCI updated CTRP to support capture and output of the FDAAA Final Rule data elements:
    1. The Protocol Abstraction (PA) web application, used by the CTRO, captures all new/modified FDAAA Final Rule data elements.  These new/modified FDAAA Final Rule data elements are submitted to the CTRO during this phase to update the trial record during new trial/amendment abstractions. 
    2. CTRP Abbreviated trial imports from ClinicalTrials.gov include the new/modified data elements if already provided on the ClinicalTrials.gov record.
    3. Nightly export of NCI-Sponsored trials from CTRP to the ClinicalTrials.gov Protocol Registration System (PRS) include the new/modified data elements.
    4. The CTRP-generated XML file that will be available after the processing of a new trial or amendment in CTRP includes all the new/modified FDAAA Final Rule data elements.
    5. The ClinicalTrials.gov PRS "Upload from NCI CTRP" feature imports the new/modified data elements, if submitted to the CTRO to update the trial record during new trial/amendment abstraction.
  2. Phase 2 - In August 2017, NCI updated the CTRP trial registration website and services to support the capture of all FDAAA Final Rule data elements.
    1. CTRP Registration REST services support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
    2. Cancer Center CTRP users can enter the new/modified FDAAA Final Rule data elements directly in CTRP via the Registration web application. 
    3. All FDAAA Final Rule/ClinicalTrials.gov fields are now optional. The "XML Required" field will no longer be available.
  3. Phase 3 - In August 2017, NCI completed implementation including the following:
    1. The Trial Summary Report (TSR) includes the new/modified data elements as applicable.
       

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