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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

jesse.anderson@fda.hhs.gov

Michael Rosentreter

michael.rosentreter@bayer.com

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





Objectives and DeliverablesTimelines
Establish definitions for QC proceduresQ2 2021 

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

Q2 2021


Status
colourBlue
titleCurrent Status
 Q22021 Q3/42021

Submitted white paper through the clearance process that describes SEND Dataset QC recommendations for industry.​

Prepare poster if abstract proposal is approved.​

Work through any changes to the white paper based on reviewer feedback.Processed white paper public review comments  initiated list of standard explanations for validation issues (nSDRG section 5). 

White paper review completed. Final version to be submitted in the next quarter. 



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



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 & Development
Soujanya KondaIQVIA 

Stefano Gaudio 

Roche

Steve Polly 

GSK

Susie Antvorskov

Data Standards Decisions
Yue LiuLabcorp