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- Phase 1 - In May 2017, NCI updated CTRP to support capture and output of the FDAAA Final Rule data elements:
- 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.
- CTRP Abbreviated trial imports from ClinicalTrials.gov 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) include the new/modified data elements.
- The CTRP-generated XML file sent to centers after 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.
- 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.
- Phase 2 - In 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
- .
- CTRP Registration REST services support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
- Cancer Center CTRP users can enter the new/modified FDAAA Final Rule data elements directly in CTRP via the Registration web application.
- The PA web application All FDAAA Final Rule/ClinicalTrials.gov fields are now optional. The "XML Required" field , used by the CTRO, is will no longer be available. Note: The XML Required field was not a FDAAA Final Rule mandatory field.
- Phase 3 - Planned for mid-late In August 2017, complete NCI completed implementation including the following:
- The Trial Summary Report (TSR) will include includes the new/modified data elements as applicable.
The data warehouse (DW) will have the phase value Early Phase 1 instead of O.
- The Trial Summary Report (TSR) will include includes the new/modified data elements as applicable.
For questions at any time, contact ncictro@mail.nih.gov.
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