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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

chris.price.cp1@roche.com

Lori VanMeterlvanmet@ITS.JNJ.com
Katie Warren (PHUSE Project Assistant)

katie@phuse.global.

Objectives & DeliverablesTimelines

Kick off

Q12022

Review current company practices 

Q12022

Develop conference abstract 

Q22022

Draft paper 

Q32022

Conference slides 

Q42022

Final paper for public review

Q42022

Final paper published

Q12023

CURRENT STATUS

Project approved Q12022
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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