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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

Key Milestones 

ObjectiveTimelineCollate a list of questions for the FDA around QCing Q4 2020 
Katie Warren (PHUSE Project Assistant)katie@phuse.global



Status
colourBlue
titleCurrent Status

Explored the Variety of QC procedures amongst team members and came up with recommendations. 

Project Members 

Organisation Anja MetzgerBayer

Brett Coupland

Astrazeneca

Cathy Roy

Merck

Christy Kubin 

MPI Research

Daniel Potenta 

PDS Lifesciences

Debra Oetzman

Instem

Deepika V.G 

Point CrossFlorence Halbert NovartisGitte Frausing Data Standards DecisionsHepei Chen FDAJack Baker CovanceJennifer Abbott AbbvieJennifer Feldmann EpredaKaren Porter Point CrossKenneth Hershman Novartis

Volunteer Today

Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu. 

Q3/4 2022 

Project Closed 




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