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Project Scope

Across industry, there are a wide variety of quality control (QC) checks for SEND datasets. This is currently done without commonly acknowledged scope and intensity, based on the companies own approaches. For more confidentiality of the quality of SEND dataset across different stakeholders this group targets to:

  • Explore the variety of QC procedures and tools among different stakeholders

  • Identify practical amount of QC checking of SEND datasets (including the QC checks for the comparison of SEND datasets and the study report)

  • Identify a suite of tools and procedures (e.g. visualisation, documentation, etc) for QC

  • Develop recommendations for stakeholders for efficient and effective SEND QC practices and, in the long term, for starting a foundation of commonly agreed QC procedures


Project Leads

Email

Jesse Anderson (FDA)

jesse.anderson@fda.hhs.gov

Michael Rosentreter (Bayer)

michael.rosentreter@bayer.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global
Objectives and DeliverablesTimelinesEstablish definitions for QC proceduresQ2 2021 

Establish consolidated list of recommended QC checks based on those definitions, subgroup feedback, and FDA feedback

Q2 2021

Planned poster for PHUSE CSS 2022

Q32022



Status
colourBlue
titleCurrent Status

Q12022
  • Sent white paper for publishing on the PHUSE website
  • Q3/4 2022 

    Project Closed 

    Worked
    • on list of standard explanations for validation issues
    Developed idea and approach to present
    • Presented findings at the
    CSS 2022

    Project Members 

    Organisation 

    Alejandro Mankin 

    FDA

    Arianne Motter 

    FDA

    Brett Coupland 

    AstraZeneca

    Cassandra O’Malley 

    PDS Life Sciences

    Diane Boram 

    GSK

    Eduardo Mundo 

    Nektar

    Erin Tibbs-Slone

    Charles River

    Haley Wulff 

    BASi 

    Isaac Mativo 

    PointCross

    Jamie Gilliam

    Instem

    Janessa Piers 

    Merck

    Jennifer Feldmann

    FDA

    Karen Porter 

    PointCross

    Karuna Polavarapu  

    PointCross

    Kathryn Brown 

    Sanofi
    • PHUSE/FDA CSS 2022




    Objectives & DeliverablesTimelines
    Produce list of standard explanations for validation issues Q2 2022
    White Paper: Recommendations for SEND Dataset QC Best PracticesQ2 2022

    Planned poster for PHUSE CSS 2022

    Q3 2022


    Published Deliverables
    Recommendations for SEND Dataset QC Best Practices21 June 2022

    Project Members 

    Organisation 

    Kurien Abraham 

    PointCross

    Laura Kaufman 

    PointCross

    Lindsy Eickhoff 

    Inotiv

    Mandie Rhodes 

    Bristol Myers Squibb

    Matt Bendekovits 

    Merck

    Matt Hayes 

    Gene

    Patty Brundage 

    FDA

    Peyton Myers 

    FDA

    Phil Drew 

    PDS Life Sciences

    Rick Thompson 

    Janssen Research & Development

    Senthil Palani  

    Xybion

    Sonja Geuens 

    Janssen Research & DevelopmentSoujanya KondaIQVIA 

    Stefano Gaudio 

    Roche

    Steve Polly 

    GSK

    Susie Antvorskov

    Data Standards DecisionsYue LiuLabcorp