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Project Scope

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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 & Johnsonlvanmet@ITS.JNJ.com
Katie Warren (
Nicola Newton, PHUSE Project Assistant
)
katie@phuse

nicky@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


Status
colourBlue
titleCURRENT STATUS

Project approved Q12022Project MembersOrganisationRama EmpatiAstraZenecaBess Leroy CDISCLisa LinFDAJohn Scott FDALiping Sun FDASteve Wilson FDAKim MusgraveAmgenCedric DavisterMerck 

Robin White

Eli Lilly and Company

Yongming Qu

Eli Lilly and CompanySantosh K LingalaGilead

Q3 2024

  • Continued to address public comments including those newly received from the FDA and EIWG.




Objectives & DeliverablesTimelines

Submit abstracts for multiple conferences 

Q2 2023

Develop draft White Paper for internal project review prior to PHUSE Working Group Review and Public Review

Q3 2023

 Final White Paper

Q1 2024