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  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 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
    3. early
  3. August 2017, NCI updated the CTRP trial registration website and services to support the capture of all
    4. required
  4. FDAAA Final Rule data elements
    5. , as long as they are submitted to CTRP during new trial/amendment registrations
  5. .
    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. The All FDAAA Final Rule/ClinicalTrials.gov fields are now optional, the "XML Required" field will no longer be available.   Note:  This was not a FDAAA Final Rule mandatory field.
  6. Phase 3 - Planned for late August 2017, complete implementation including the following:
    1. The Trial Summary Report (TSR) will include the new/modified data elements as applicable.
      The data warehouse (DW) will be updated to use the phase value "Early Phase 1" instead of "O". 

For questions at any time, contact ncictro@mail.nih.gov.

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