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Project Scope 

Impact assessment of the estimands framework and recommendations/best practices (where applicable) for implementing the framework in the following areas:

  • Data Collect Design/CDASH
  • SDTM
  • ADaM (including handling of intercurrent events, missing data imputation) – Analysis Displays
  • cSDRG and ADRG

Development of new standards is not in scope, and any impact findings that may necessitate new standard development will be shared with CDISC for their consideration. Examples may be created on how to implement the framework by using permitted extensions to the existing data standards.



Project LeadsEmail
Chris Price, Roche

chris.price.cp1@roche.com

Lori VanMeter, Johnson & Johnsonlvanmet@ITS.JNJ.com
Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


  • White Paper published for public review
    • Presented at the EU Connect on proposed solutions

    Status
    colourBlue
    titleCURRENT STATUS
    Q4 2023

    Q2 2024

    • Completed public review of White Paper
    • Great interest in paper as received over 400 public comments
    • Collaborating with EIWG statisticians to align white paper recommendations
    • Poster session at the US Connect and presentation at International Society for Biopharmaceutical Statistics (ISBS) 2024




    Objectives & DeliverablesTimelines

    Submit abstracts for multiple conferences 

    		Q2 2023

    Develop draft White Paper for internal project review prior to PHUSE Working Group Review and Public Review

    		Q3 2023

     Final White Paper

    		Q1 2024