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Nonclinical Protocol Automation

    Nonclinical Protocol Automation

    Mar 15, 2024

    Project Scope 

    Determine the feasibility of transforming the BioCelerate Nonclinical Protocol Template into a dynamic Microsoft Word document where filling in the template allows output of all fields for machine readability. Determine the feasibility of expanding the OpenStudyBuilder system for nonclinical study usage. Explore the output and API functionality of this system. Based upon conclusions from the above, work with one or both groups to complete a pilot for creating a few model study designs for demonstration of protocol automation.

    Problem Statement 

    The industry is very interested in developing an automation of protocol development to a final protocol for nonclinical studies. Currently, this is mainly managed using manual document authoring based on company-specific templates.

    Problem Impact 

    The benefit for industry with an automation of protocol:

    • Easier to implement standard structure and format of protocol document.
    • Ability to electronically transfer protocol designs between sponsors and CROs during study initiation.
    • Trial design domains that become part of the SEND study submission could come from this system and at the time of protocol conceptualisation instead of at the end of a study, which would lead to more accuracy, efficiency and completeness of contents.

    Relationship to previous projects

    • OpenStudyBuilder: a CDISC Open Source Alliance Project to automate clinical protocol development.
    • Related to the BioCelerate nonclinical study template project (which is a shared common template but a nonautomated approach to protocol development).

    Stakeholders

    • Software providers, sponsors, CROs
    • CDISC
    • OpenStudyBuilder project team
    • BioCelerate
    • FDA and other regulatory agencies
    Project LeadsEmail 

    Bob Friedman, Xybion

    bfriedman@xybion.com

    Alex Pearce, PHUSE Project Assistant

    Alexandra@phuse.global

    CURRENT STATUS Q1 2024

    • Project Closing out
    • Leads producing a white paper on what was researched
    Objectives & DeliverablesTimelines

    Feasibility trial of the Nonclinical Protocol Template from a dynamic Microsoft Word document

    Q1 2024

    Feasibility trial of the OpenStudyBuilder system for nonclinical study usage. This is done by comparing its clinical study abilities to the needs for nonclinical studies and by exploring the output and API functionality of this system

    Q1 2024

    Create three example study designs using one or both of these approaches

    Q2 2024

    Prepare Phase I results as a CSS meeting presentation

    Q3 2024

    Presentation of lessons learned and project status at the CSS meeting 

    Q4 2024
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    WORKING GROUPS
    Results will update as you type.
    • Working Groups
    • Hot Topics
    • Useful Information
    • Deliverables
    • Working Groups Events
    • Working Groups Report – Q3 2025
    • Working Groups Archive
      • Data Transparency Archive
      • Data Visualisation & Open Source Technology Archive
      • Emerging Trends & Technologies Archive
      • Nonclinical Topics Archive
        • SEND Dataset QC Best Practices
        • Application of SEND Data for Analysis
        • Data Consistency: SEND Datasets and Study Report 
        • Data Visualisation as an Enabler for Nonclinical Safety Signal Detection
        • Demystifying Define-XML Codelist Handling for Nonclinical Studies
        • Harmonization of SEND Implementation to Enable Historical Control Data Analysis
        • Interorganizational SEND
        • Investigating Endpoint Modeling - Biomarkers
        • Nonclinical Data Interconnectivity for Endpoint Predictivity (NICE)
        • Nonclinical Historical Controls
        • Nonclinical Working Group Industry Discussion Group
        • Nonclinical Protocol Automation
        • Nonclinical Scripts
        • Scenario Experience
        • SEND Implementation Wiki
        • Standardization Roadmap
        • Testing Simplified TS Examples Against FDA Technical Rejection Criteria
        • Test Submission Forum Group
        • The Roadmap for Nonclinical Data Standards and Elements to Improve Data Access
        • Visualization of Group Related Differences in Histopatholgy Data
        • SEND Industry Feedback Surveys
        • SEND Implementation User Group
      • Optimizing the Use of Data Standards Archive
      • Risk Based Quality Management Archive
      • Real World Evidence Archive
      • Therapeutic Areas
      • Good Programming Practice Project Team
      • Working Group Report Archive
      • Safety Analytics Archive
    • Working Groups Events Archive
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