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 | |
|---|---|
Kevin Synder (FDA) | |
Mark Carfagna (Eli Lilly, BioCelerate Consortium) | |
| Katie Warren (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
|---|---|
| PHUSE Publication of White Paper: Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology | Q2 2022 |
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| Resources |
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| Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology |
Project Members | Organisation |
|---|---|
| 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 |
| 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 |
Rupesk Katta | Xybion |
| SivaRamaKrishna SivaRamaKrishna VemiReddy | Pointcross |
| Steve Polley | GSK |
Sudharrshan Muthukumarasamy | Xybion |
| Sue Dehaven | Sanofi |
| Todd Page | Eli Lilly |
| Vidhuna Sadanandan | Labcorp |
| Wang Wenxian | Bristol Myers Squibb, BioCelerate Consortium |
| William Houser | Bristol Myers Squibb |