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 | |
| Lauren White (PHUSE Project Coordinator) | lauren@phuse.global |
| Objectives and Deliverables | Timeline |
|---|---|
| Complete the Docker POC Project | Q4 2020 |
| Kick off the Docker pilot for a real submission | Q4 2020 |
White Paper on best practices for interactive analyses for decision making & submissions | Q4 2020 |
CURRENT STATUS Q42020 |
| Python data set generator and the web interface to user configuration for the data set engine contributions continue |
Project Members | Organisation |
|---|---|
Alexey Kuznetsov | GSK |
Cynthia Stroupe | UCB |
Jessica Dai | Vertex |
| Mazibuko Ntintelo | Industry |
Nancy Brucken | CSG |
Peter Schaefer | VCA-Plus |