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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 

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

Gitte Ullmann 

Novo Nordisk

Haley Wulff 

Basinc

Isaac Mativo 

PointCross

Jamie Gilliam

Instem

Janessa Piers 

Merck

Jennifer Feldmann

FDA

Karen Porter 

PointCross

Karuna Polavarapu  

PointCross

Kathryn Brown 

Sanofi

Project Members 

Organisation 

Kurien Abraham 

PointCross

Laura Kaufman 

Pointcross

Lindsy Eickhoff 

Basinc

Mandie Rhodes 

BMS

Matt Bendekovits 

Merck

Matt Hayes 

Gene

Patty Brundage 

FDA

Peyton Myers 

FDA

Phil Drew 

PDS-Consultants

Rick Thompson 

JNJ

Senthil Palani  

Xybion

Sonja Geuens 

JNJ

Stefano Gaudio 

Roche

Steve Polly 

GSK

Susie Antvorskov

Data Standards Decisions

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