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
Michael Rosentreter Co-lead Bayer

Project Members

Name Role Organization E-mail
Alejandro Mankin Participant FDA
Amy Shelton Participant
Arianne Motter Participant FDA
Brett Coupland Participant Astrazeneca
Cassandra O’Malley Participant PDS Life Sciences
Diane Boram Participant GSK
Eduardo Mundo Participant Nektar
Erin Tibbs-Slone Participant Charles River
Gitte Ullmann Participant Novo Nordisk
Haley Wulff Participant Basinc
Isaac Mativo Participant PointCross
Jamie Gilliam Participant Instem
Janessa Piers Participant Merck
Jennifer Feldmann Participant FDA
Karen Porter Participant PointCross
Karuna Polavarapu Participant PointCross
Kathryn Brown Participant Sanofi
Kurien Abraham Participant PointCross
Laura Kaufman Participant Pointcross
Lindsy Eickhoff Participant Basinc
Maja Carlson Participant Gilead
Matt Bendekovits Participant Merck
Matt Hayes Participant Gene
Patty Brundage Participant FDA
Peyton Myers Participant FDA
Phil Drew Participant PDS-Consultants
Rick Thompson Participant JNJ
Sonja Geuens Participant JNJ
Stefano Gaudio Participant Roche
Steve Polly Participant GSK
Susie Antvorskov Participant Data Standards Decisions
Mandie Rhodes Participant BMS
Senthil Palani Participant Xybion

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