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Conformance with the tumor.xpt Specification

    Conformance with the tumor.xpt Specification

    Oct 01, 2025

    Project Scope 

    The scope of the project will be to create a non-exhaustive first set of technical conformance rules with the tumor.xpt specification.

    Problem Statement 

    Since 1999, the FDA has requested that industry provide tumour data from nonclinical studies in a specified format (‘tumor.xpt’). This data is now submitted jointly with SEND datasets. Where the SEND standard comes with a set of conformance rules from CDISC, the tumor.xpt specification does not have these, and consequently this file, unlike the adjoining SEND datasets, is not currently validated using out-of-the-box tools. Since the tumor.xpt format is not a CDISC standard, it is confirmed that the CDISC SEND team will NOT provide such conformance rules with the tumor.xpt format. Consequently, there is currently a manual burden on industry to verify the adherence of the tumor.xpt file to the FDA specification.

    Problem Impact 

    This project will provide the first set of validator rules to be implemented by tools already used by the industry for verification of SEND datasets, thus removing part of the current manual burden of reviewing this file. The benefit for industry, with an automation of these checks, will be increased quality of the tumor.xpt file and reduced time to generate it. With an increased quality of the tumor.xpt file, it is expected that less communication will be needed between sponsors and the FDA to discuss potential issues with the tumor.xpt file. Should the FDA decide to adopt these conformance rules, they can benefit by getting an early insight into any potential issues they could encounter when reviewing the data, thus also increasing actual data review time and not spending it on identifying and correcting issues with the format.

    Project LeadsEmail 
    Gitte Frausing, Data Standards Decisions

    gfrausing@datastandardsdecisions.com

    Hepei Chen, FDA

    hepei.chen@fda.hhs.gov

    Alex Pearce, PHUSE Project Assistant

    Alexandra@phuse.global

    CURRENT STATUS (Updated Quarterly) 

    • Project on hold
    • Leads to follow up on next steps​​
    Objectives & DeliverablesTimelines
    Kick off meeting and agree on a regular meeting schedule Q2 2023
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    WORKING GROUPS
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    • Working Groups
      • Data Transparency
      • Data Visualisation & Open Source Technology
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        • Conformance with the tumor.xpt Specification
        • Developing Predictive Models to Facilitate Interpretation of Toxicology Study Results
        • Nonclinical Study Data Reviewer's Guide
        • SEND Coding Bootcamp
        • SEND Industry Feedback Survey
        • Supporting the Use of SEND for the Implementation of Virtual Control Groups
      • Optimizing the Use of Data Standards
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