Project Scope The scope of this project is to evaluate and recommend approaches for |
SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. |
Project Leads | |
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Kevin Synder (FDA) | |
Mark Carfagna (Eli Lilly, BioCelerate Consortium) | |
Katie Warren (PHUSE Project Assistant) |
Objectives & Deliverables | Timelines |
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Prioritised list of domains/variables required for harmonisation | Q32020 |
Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as needed | Q22021 |
Poster presentation and update of current Working Group progress at CSS | Q32021 |
PHUSE Publication of White Paper | Q22022 |
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Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology White Paper sent out for public review |
Resources |
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Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology |
Project Members | Organisation |
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Annika Kreuchwig | Bayer |
Bill Houser | Bristol Myers Squibb, BioCelerate Consortium |
Cara Rinaldi | BioCelerate |
Cheryl Sloan | Bristol Myers Squibb, BioCelerate Consortium |
Deepa Smant | Comcast |
Frank Bringezu | Merck |
Gen Sato | Eisai |
Joseph Horvath | Bristol Myers Squibb |
Laura Kaufman | Pointcross |
Lokesh Babu | Pointcross |
Matthew Crawley | Biocelerate |
Michael DeNieu | Labcorp |
Michael Wasko | PDS Life Sciences |
Michele Dunleavy | Biocelerate |
Nicolas Philippe | PointCross Life Sciences |
Patricia Brundage | FDA |
Rick Thompson | Janssen Research & Development, BioCelerate Consortium |
SivaRamaKrishna VemiReddy | Pointcross |
Steve Polley | GSK |
Sue Dehaven | Sanofi |
Todd Page | Eli Lilly |
Vidhuna Sadanandan | Labcorp |
Wang Wenxian | Bristol Myers Squibb, BioCelerate Consortium |
William Houser | Bristol Myers Squibb |