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 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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José Lacal (NIHPO)
Nicola Newton, PHUSE Project Assistant |
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Project currently on hold. |
Objectives & Deliverables | Timelines | |||||
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NIHPO API formal release | Q2 Q3 2021 | |||||
White Paper on state of the art of Biopharma Data Synthesis | Q2 2021 | |||||
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NIHPO API can synthesise partially conformant, credible datasets (CDISC). Iterations to improve conformance and credibility are now the focus of the TDF team. Discussion continues on support for user-specific “credibility” needs. API for NIHPO synthetic building blocks to be released in Q32021. | ||||||
Project Members | Organisation | |||||
Alexey Kuznetsov | GSK | |||||
Cynthia Stroupe | UCB | |||||
Jessica Dai | Vertex | |||||
Mazibuko Ntintelo | Industry | |||||
Nancy Brucken | CSG | |||||
Peter Schaefer | VCA-PlusQ4 2021 |