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Comment: Revised based on email conversation with Michael Izbicki.

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  1. Phase 1 - In May 2017, NCI will update CTRP to support capture and output of the FDAAA Final Rule data elements:
    1. The Protocol Abstraction (PA) web application, used by the CTRO, will capture all new/modified FDAAA Final Rule data elements.  Until CTRP Registration is updated, these new/modified FDAAA Final Rule data elements will need to be submitted to the CTRO to update the trial record during new trial/amendment abstractions.  Instructions provided below.
    2. CTRP Abbreviated trial imports from ClinicalTrials.gov will 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) will 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 will include all the new/modified FDAAA Final Rule data elements
    5. ClinicalTrials.gov PRS "Upload from NCI CTRP" will import the new/modified data elements, if submitted to the CTRO to update the trial record during new trial/amendment abstraction.
    6. Exclusions: The CTRP Trial Registration Website and Services will not be able to capture the new/modified data elements directly.  The Trial Summary Report (TSR) will not reflect the new/modified FDAAA Final Rule data elements. Until Phase 2 (see below) is released, this information will need to be submitted to the CTRO to update the trial record during new trial/amendment abstractions in CTRP.
  2. Phase 2 - Planned for end of July or early August 2017:
    1. Registration REST Services: CTRP REST services will support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
    2. PA web application: The XML Required flag field will be removed. (The XML Required field is not a FDAAA field. It is mentioned on this page only for clarity.)
    3. Registration web application: Users will be entering the new/modified FDAAA Final Rule data elements directly to CTRP via the Registration web application. The XML Required flag field will be removed.
  3. Phase 3 - Planned for August 2017, complete implementation:
    1. The Trial Summary Report (TSR) will include the new/modified data elements if applicable.
    2. The data warehouse (DW) will have the phase value Early Phase 1 instead of O.

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