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 | Q12022Q1 2022 |
Review current company practices | Q12022Q1 2022 |
Develop conference abstract | Q22022Q2 2022 |
Draft paper paper | Q32022Q3 2022 |
Conference slides | Q42022Q4 2022 |
Final paper for public review | Q42022Q4 2022 |
Final paper published | Q12023Q1 2023 |
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Project approved Q12022Q1 2022 |
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 |