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Project Scope 

The scope for the project covers twin objectives:

  1. Demonstrate that Dataset-JSON can transport information with no disruption to business​
  2. Demonstrate the viability of Dataset-JSON as the primary transport option


Sub Teams

1. Pilot Submissions Report

  • Consolidate feedback from the pilot submissions and develop report

2. Business Case

  • Establish the overall business case for using Dataset-JSON for submissions to justify the investment needed to implement the changes​

3. Technical Implementation

  • Develop and document software tools to be used in the pilot to include updates to existing products​

4. Strategy for Future Development

  • Define a roadmap for future development and changes to the CDISC Foundational Standards


Project Impact 

The XPT file format is outdated and imposes limitations on submission data due to the lack of modern features – for example, XPT files are limited to US ASCII Character encoding, have restricted variable names/sizes, inefficient use of storage space, use a non-extensible tabular structure and lack any integrated metadata. The impact of overcoming these limitations will be seen initially by regulators; however, by far the bigger impact will be seen in the medium to longer term, where, by lifting the restrictions of XPT, and moving to Dataset-JSON, new standards will be able to take advantage of these enhanced capabilities, and drive efficiencies, consistency and re-usability across the clinical research data life cycle.



Project LeadsEmail

Sam Hume, CDISC

shume@cdisc.org 

Stuart Malcolm, Veramed

stuart.malcolm@veramed.co.uk

Jesse Anderson, FDA

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


  • Pilot Submissions Report:

    • Consolidate feedback from the pilot submissions and develop report.

  • Business Case:

    • Establish the overall business case for using Dataset-JSON for submissions to justify the investment needed to implement the changes.  

  • Technical Implementation:

    • Develop and document software tools to be used in the pilot to include updates to existing products.  

    • Strategy for Future Development:

    Define a roadmap for future development and changes to the CDISC Foundational Standards.

    Status
    colourBlue
    titleCurrent Status
    Q2 2024

    Q1 2025

    • Restarted work on Business Case and Future Opportunities Documents




    Objectives & Deliverables

    Timelines

    PHUSE Team formation 

    Engaged with collaboration partners (CDSIC, FDA etc.)

    Q2 2023

    Initial technical/ regulatory deliverables

    CSS workshop – Workstream roundtable 

    		Q3 2023
    Industry deliverables (PHUSE EU Connect)Q4 2023
    Standards deliverablesQ1 2024 

    All project deliverables published 

    CSS workshops – Project findings and recommendations

    		Q2 2024


    Resources 
    Summary of the pilot findings to date and recommended solutions
    Pilot participation testing and reporting instructions
    SBIA webinar: Dataset-JSON Pilot Report and Next Steps



    Dataset-JSON Webinar

    Please find the recording and presentations from the Webinar that took place on 1 February.

    Introduction, presented by Stuart Malcom, Veramed

    Pilot Submissions Status Update, presented by Sam Hume, CDISC
    Technical Implementation Topics, presented by Jesse Anderson, FDA
    Business Case, presented by Marguerite Kolb, Johnson & Johnson
    Strategy for Future Development, presented by Nicole Thorne, BMS