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
|Objectives and Deliverables||Timelines|
|NIHPO API formal release||Q2 2021|
White Paper on state of the art of Biopharma Data Synthesis
CURRENT STATUS Q22021
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.