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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 as per the following:

  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 sent to centers 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" import 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 late July 2017/early August 2017, NCI updated the CTRP trial registration website and services to support the capture of all required FDAAA Final Rule data elements, as long as they are submitted to CTRP during new trial/amendment registrations.
    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 to CTRP via the Registration web application. 
    3. The PA web application "XML Required" field, used by the CTRO, is no longer available.  Note:  The XML Required field was not a FDAAA Final Rule mandatory field.
  3. Phase 3 - Planned for August 2017, complete implementation:
    1. The Trial Summary Report (TSR) will include the new/modified data elements as applicable.
    2. The data warehouse (DW) will have the phase value Early Phase 1 instead of O.

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