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:

• 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.