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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 (Janssen Research & Development), Johnson & Johnsonlvanmet@ITS.JNJ.com
Nicola Newton (, PHUSE , Project Assistant)

nicky@phuse.global


Status
colourBlue
titleCURRENT STATUS
Q2 2023

Team is continuing work on the White Paper




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