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 |
|---|
Dante Di Tommaso
| Nicola Newton, PHUSE Project Assistant |
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Project currently on hold. |
| Objectives & | ||||||
|---|---|---|---|---|---|---|
| Deliverables | Timelines | |||||
| NIHPO API formal release | ||||||
| Q3 2021 | ||||||
White Paper on state of the art of Biopharma Data Synthesis | Q2 2021 | |||||
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Working towards database "conformance" to ensure structural and content conformance of SDTM synthetic data using Pinnacle 21 evaluation. | ||||||
Project Members | Organisation | |||||
Alexey Kuznetsov | GSK | |||||
Cynthia Stroupe | UCB | |||||
Jessica Dai | Vertex | |||||
| Mazibuko Ntintelo | Industry | |||||
Nancy Brucken | CSG | Peter Schaefer | VCA-Plus||||
| Q4 2021 |