Project Scope
Project Scope |
Several Working Group projects develop and specify medical research methods, features or processes, and some even create software components or sub-systems for common tasks in drug development. As part of these efforts, a variety of SDTM or ADaM test datasets are required. The typical fallback position of project teams is to use data from the CDISC pilot project and/or anonymised study data that are provided by project team members. The Test Dataset Factory project aims to provide test data formatted in SDTM and ADaM that support a more systematic and comprehensive testing of these concepts and scripts. |
Project Leads |
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Dante Di Tommaso
Key Milestones
White Paper on best practices for interactive analyses for decision making & submissions
Project Members
Alexey Kuznetsov
GSK
Cynthia Stroupe
UCB
Jessica Dai
Nancy Brucken
CSG
Peter Schaefer
Status | ||||
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Nicola Newton, PHUSE Project Assistant |
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Project currently on hold. |
Objectives & Deliverables | Timelines |
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NIHPO API formal release | Q3 2021 |
White Paper on state of the art of Biopharma Data Synthesis | Q4 2021 |