NIH | National Cancer Institute | NCI Wiki  

WIKI MAINTENANCE NOTICE

Please be advised that NCI Wiki will be will be undergoing maintenance on Monday, June 24th between 1000 ET and 1100 ET.
Wiki will remain available, but users may experience screen refreshes or HTTP 502 errors during the maintenance period. If you encounter these errors, wait 1-2 minutes, then refresh your page.

If you have any questions or concerns, please contact the CBIIT Atlassian Management Team.

Error rendering macro 'rw-search'

null

Versions Compared

Old Version 2

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

compared with

New Version 3

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Rearranging phase 2 based on message from Susan Nonemaker.

...

  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, complete implementation:
    1. Registration web application:  Users will be entering the new/modified FDAAA Final Rule data elements directly to CTRP via the Registration web application.
    2. 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.
    3. Registration web application:  Users will be entering the new/modified FDAAA Final Rule data elements directly to CTRP via the Registration web application.
  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.

...