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, Roche | |
| Lori VanMeter, Johnson & Johnson | lvanmet@ITS.JNJ.com |
| Nicola Newton, PHUSE Project Assistant |
| Continued to address public comments including those newly received from the FDA and EIWGQ4 2024 | ||||||||
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| Objectives & Deliverables | Timelines |
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 |