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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

...

jesse.anderson@fda.hhs.gov
Michael Rosentreter

...

michael.rosentreter@bayer.com


Key Milestones 

ObjectiveTimeline
Collate a list of questions for the FDA around QCing Q4 2020 

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 Cross
Florence Halbert Novartis
Gitte Frausing Data Standards Decisions
Hepei Chen FDA
Jack Baker Covance
Jennifer Abbott Abbvie
Jennifer Feldmann Epreda
Karen Porter Point Cross
Kenneth 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.