Implementation of Estimands (ICH E9 (R1)) using Data Standards
Implementation of Estimands (ICH E9 (R1)) using Data Standards
Project Scope |
Impact assessment of the estimands framework and recommendations/best practices (where applicable) for implementing the framework in the following areas:
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 Leads | |
Chris Price, Roche | |
Lori VanMeter, Johnson & Johnson | lvanmet@ITS.JNJ.com |
Nicola Newton, PHUSE Project Assistant |
CURRENT STATUS Q1 2025 | |
|
Objectives & Deliverables | Timelines |
Q2 2025 |
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