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 | |
|---|---|
José Lacal | |
| Lauren White (PHUSE Project Coordinator) | lauren@phuse.global |
| Objectives and Deliverables | Timelines |
|---|---|
| NIHPO API formal release | Q2 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-Plus |