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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

Q1 2022

Review current company practices 

Q1 2022

Develop conference abstract 

Q2 2022

Draft paper

Q3 2022 

Conference slides 

Q4 2022

Final paper for public review

Q4 2022

Final paper published

Q1 2023

CURRENT STATUS

Project approved Q1 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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