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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, 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 - In late July 2017/early August 2017, NCI updated CTRP trial registration website and services which are now able 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 now support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
    2. Cancer Center 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 was removed.  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 if applicable.
    2. The data warehouse (DW) will have the phase value Early Phase 1 instead of O.

Keep in mind the following points:

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  • Use CTRP for trial registration. Submit the new/modified FDAAA Final Rule data elements to the CTRO to update the trial record during new trial/amendment abstractions. Complete this Microsoft Excel template and submit to the CTRO: FDAAA_Final_Rule_fields-5-2017.xlsx.
  • If you are registering a Device trial, please contact the CTRO.

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    1. .

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

The following tables briefly list the changes in CTRP to support the FDAAA Final Rule.

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