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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 LeadsEmail

José Lacal (NIHPO)

jose.lacal@nihpo.com

Paula Rowley (PHUSE Project Assistant)paula@phuse.global



Objectives & DeliverablesTimelines
NIHPO API formal releaseQ3 2021

White Paper on state of the art of Biopharma Data Synthesis 

Q4 2021 


  • 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

    Status
    colourBlue
    titleCurrent Status
     Q2Q3/3 2022

    4 2022

    • Project currently on hold.​



    Project Members 

    Organisation 

    Alexey Kuznetsov

    GSK

    Cynthia Stroupe

    UCB

    Jessica Dai

    Vertex
    Mazibuko NtinteloIndustry

    Nancy Brucken

    CSG

    Peter Schaefer

    VCA-Plus