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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

Katie Warren (PHUSE Project Assistant)

Objectives & DeliverablesTimelines

Kick off

Feb 2022

Review current company practices 

March 2022

Develop conference abstract 

April 2022

Draft paper 

August 2022

Conference slides 

Oct 2022

Final paper for public review

Nov 2022

Final paper 

Jan 2023


Project approved Feb 2022
Project MembersOrganisation
Rama EmpatiAstraZeneca
Bess Leroy CDISC
Lisa LinFDA
John Scott FDA
Liping Sun FDA
Steve Wilson FDA
Kim MusgraveAmgen
Cedric DavisterMerck 

Robin White

Eli Lilly and Company

Yongming Qu:

Eli Lilly and Company
Santosh K LingalaGilead
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