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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 to be published for public review
    • Presentation at the EU Connect on proposed solutions

    Status
    colourBlue
    titleCURRENT STATUS
    Q4 2023

    Q3 2024

    • Continued to address public comments including those newly received from the FDA and EIWG.




    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