SEND Dataset QC Best Practices

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Project Overview

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. visualization, 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

Name Role Organization E-mail
Jesse Anderson Co-lead FDA jesse.anderson@fda.hhs.gov
Michael Rosentreter Co-lead Bayer michael.rosentreter@bayer.com

Project Members


Name Role Organization E-mail
Alejandro Mankin Participant FDA Alejandro.Mankin@fda.hhs.gov
Amy Shelton Participant
Arianne Motter Participant FDA arianne.motter@fda.hhs.gov
Brett Coupland Participant Astrazeneca brett.coupland@astrazeneca.com
Cassandra O’Malley Participant PDS Life Sciences cassandra.omalley@pdslifesciences.com
Eduardo Mundo Participant Nektar emundo@nektar.com
Erin Tibbs-Slone Participant Charles River Erin.Tibbs-Slone@crl.com
Haley Wulff Participant Basinc hwulff@basinc.com
Isaac Mativo Participant PointCross isaac@pointcross.com
Jamie Gilliam Participant Instem jamie.gilliam@instem.com
Janessa Piers Participant Merck janessa_pierce@merck.com
Jennifer Feldmann Participant FDA Jennifer.Feldmann@fda.hhs.gov
Karen Porter Participant PointCross karen@pointcross.com
Karuna Polavarapu Participant PointCross karuna@pointcross.com
Kathryn Brown Participant Sanofi kathryn.brown@sanofi.com
Kurien Abraham Participant PointCross kurien@pointcross.com
Lindsy Eickhoff Participant Basinc leickhoff@basinc.com
Maja Carlson Participant Gilead maja.carlson@gilead.com
Matt Bendekovits Participant Merck matt.bendekovits@merck.com
Matt Hayes Participant Gene hayes.matthew@gene.com
Patty Brundage Participant FDA patricia.brundage@fda.hhs.gov
Peyton Myers Participant FDA Laine.Myers@fda.hhs.gov
Phil Drew Participant PDS-Consultants philip.drew@pds-consultants.co.uk
Rick Thompson Participant JNJ RThompso@its.jnj.com
Sonja Geuens Participant JNJ SGEUENS@its.jnj.com
Stefano Gaudio Participant Roche stefano.gaudio@roche.com
Susie Antvorskov Participant Data Standards Decisions slendal@datastandardsdecisions.com
Mandie Rhodes Participant BMS Mandie.rhodes@bms.com


Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Explore the variety of QC procedures until September 2019
Identify practical amount of QC procedures until December 2019
Identify a suite of tools and procedures (e.g. visualisation, documentation, etc) for QC procedures until March 2020
Develop recommendations for stakeholders until US CSS 2020

Project Activities

This section can document project activities or serve as a jumping off point to other pages in the project.

Meeting Minutes


Archived Content