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Internal Clinical Study Data Sharing Process

    Internal Clinical Study Data Sharing Process

    Oct 01, 2025

    Project Scope 

    This project will gather feedback across industry on internal data sharing in order to provide a white paper summarising the results. The white paper will provide recommendations surrounding guidance on Internal Data Sharing Process, as well as identify similarities/differences between external and internal data sharing process. As many functions request for data internally, this could impact Statisticians, Programmers, Clinicians, Software Developers and IT.

    Project Leads Email 
    Arlene Coleman, Pfizerarlene.coleman@pfizer.com
    Lucy Marks, PHUSE Senior Project Coordinator

    lucy@phuse.global

    CURRENT STATUS (Updated Quarterly) 

    • Project kick-off meeting scheduled to discuss the path forward in this project as an extension of the GTP project and focusing on use cases which would be of further help for the industry

    • Identify another Co-Lead alongside Abby McDonell and plan an outline for the deliverable​
    Objectives & DeliverablesTimelines
    Draft White PaperQ2 2023
    Final White PaperQ1 2024
    , multiple selections available,
    Welcome to the PHUSE Advance Hub
    WORKING GROUPS
    Results will update as you type.
    • Working Groups
      • Data Transparency
        • Anonymization of Imaging Data
        • Educate the General Population on Data Privacy and Data Sharing
        • EU CTR Implementation
        • Internal Clinical Study Data Sharing Process
        • Patient Data Return
        • PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance
        • The Value of Plain Language Summaries of Trial Results
      • Data Visualisation & Open Source Technology
      • Emerging Trends & Innovation
      • Nonclinical Topics
      • Optimizing the Use of Data Standards
      • pharmaverse
      • Real World Evidence
      • Risk Based Quality Management
      • Safety Analytics
    • Hot Topics
    • Useful Information
    • Deliverables
    • Working Groups Events
    • Working Groups Report – Q3 2025
    • Working Groups Archive
    • Working Groups Events Archive
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