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- Phase 1 - In May 2017, NCI will update CTRP to support capture and output of the FDAAA Final Rule data elements:
- 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.
- CTRP Abbreviated trial imports from ClinicalTrials.gov will include the new/modified data elements if already provided on the ClinicalTrials.gov record.
- Nightly export of NCI-Sponsored trials from CTRP to the ClinicalTrials.gov Protocol Registration System (PRS) will include the new/modified data elements.
- 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
- 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.
- 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.
- Phase 2 - Planned for end of July or early August 2017, complete implementation:
- 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.
- PA web application: The XML Required flag will be removed.
- 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 will be removed.
- Phase 3 - Planned for August 2017, complete implementation:
- The Trial Summary Report (TSR) will include the new/modified data elements if applicable.
- The data warehouse (DW) will have the phase value Early Phase 1 instead of O.
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