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:
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Project Leads | |
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Jesse Anderson | |
Michael Rosentreter | |
Paula Rowley Katie Warren (PHUSE Project Assistant) | paula@phusekatie@phuse.global |
Objectives and Deliverables | Timelines |
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Establish definitions for QC procedures | Q2 2021 |
Establish consolidated list of recommended QC checks based on those definitions, subgroup feedback, and FDA feedback | Q2 2021 |
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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 |
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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 |
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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 Konda | IQVIA |
Stefano Gaudio | Roche |
Steve Polly | GSK |
Susie Antvorskov | Data Standards Decisions |
Yue Liu | Labcorp |