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) | |
| Katie Warren (PHUSE Project Assistant) |
| Objectives & Deliverables | Timelines |
|---|---|
| Prioritised list of domains/variables required for harmonisation | Q3 2020 |
| Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as needed | Q2 2021 |
| Poster presentation and update of current Working Group progress at CSS | Q3 2021 |
| PHUSE Publication or White Paper | Q2 2022 |
|
|---|
Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology White Paper sent out for public review |
| Resources |
|---|
| Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology |
Project Members | Organisation |
|---|---|
| Annika Kreuchwig | Bayer |
| Bill Houser | Bristol Myers Squibb |
Cheryl Sloan | Bristol Myers Squibb |
Deepa Smant | Comcast |
Gen Sato | Eisai |
Joseph Horvath | Bristol Myers Squibb |
| Matthew Crawley | Biocelerate |
Michele Dunleavy | Biocelerate |
| Nicolas Philippe | PointCross Life Sciences |
| Patricia Brundage | FDA |
| Rick Thompson | Janssen Research & Development |
| Steve Polley | GSK |
| Sue Dehaven | Sanofi |
| Todd Page | Eli Lilly |
| Wang Wenxian | Bristol Myers Squibb |