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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 (Roche) 

chris.price.cp1@roche.com

Lori VanMeter (Johnson & Johnson)lvanmet@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 
Ann M Pennington Pfizer 
Arman SabbaghiPurdue University
Armin SchuelerMerckgroup 
Banoo Madhanagopal Bayer 
Bess LeroyCDISC
Cedric Davister Merck
Dong Xi Gilead 
Elena PolverejanJanssen Research & Development 
Emilea Norris CDISC
Jennifer, BrittGilead
John ScottFDA
Jonathan Siegel Bayer 
Jozef AertsXML4Pharma
Junxiang LuoModerna 
Kevin LiuPfizer 
Kim Musgrave Amgen
Liping SunFDA
Lisa LinFDA
Marc Walton Janssen Research & Development 
Nilani Liyanage Jansen Research & Development 
Oliver Wirtz Bayer 
Rama Empati AstraZeneca
Robin WhiteEli Lilly and Company
Rosanne LaneJanssen Research & Development 
Santosh K Lingala Gilead 
Shahida Tamboli Labcorp 
Stephen Ruberg Analytix Thinking
Steve Gilbert Pfizer 
Steve WilsonFDA
Vidya Jayapalan Takeda
Xiaohan ZouBristol Myers Squibb
Yongming QuEli Lilly 
Yun Peng Bristol Myers Squibb
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