Project Scope Impact assessment of the estimands framework and recommendations/best practices (where applicable) for implementing the framework in the following areas:
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 Leads | |
Chris Price | |
Lori VanMeter | lvanmet@ITS.JNJ.com |
Katie Warren (PHUSE Project Assistant) |
Objectives & Deliverables | Timelines |
Kick off | Feb 2022Q12022 |
Review current company practices | March 2022Q12022 |
Develop conference abstract | April 2022Q22022 |
Draft paper | August 2022Q32022 |
Conference slides | Oct 2022Q42022 |
Final paper for public review | Nov 2022Q42022 |
Final paper published | Jan 2023Q12023 |
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Project approved Feb 2022Q12022 |
Project Members | Organisation |
Rama Empati | AstraZeneca |
Bess Leroy | CDISC |
Lisa Lin | FDA |
John Scott | FDA |
Liping Sun | FDA |
Steve Wilson | FDA |
Kim Musgrave | Amgen |
Cedric Davister | Merck |
Robin White | Eli Lilly and Company |
Yongming Qu | Eli Lilly and Company |
Santosh K Lingala | Gilead |