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Implementation of Estimands (ICH E9 (R1)) using Data Standards

Implementation of Estimands (ICH E9 (R1)) using Data Standards

Owned by Former user (Deleted)
Last updated: Mar 12, 2025 by Nicola Newton

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

CURRENT STATUS Q1 2025

  • Completed White Paper and Example Document sent for publishing.
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

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