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changes.mady.by.user Nicola Newton

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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 & Deliverables


Status

Timelines

colour

Kick off

Blue

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

Status
colourBlue
titleCURRENT STATUS

Project approved Feb 2022Project MembersOrganisationRama EmpatiAstraZeneca

titleCURRENT STATUS
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