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 | |
Mark Carfagna | |
| Paula Rowley (PHUSE Project Assistant) |
| Objectives and 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 | Q1 2022 |
| ||||||
|---|---|---|---|---|---|---|
Control Type White Paper: Addressed public reviewers’ comments and resubmitted for final publication. The scope has been broadened to include all control types. Formed working groups to progress the facility/animal supplier name and location, and RESCAT projects. Recommendations for Exchanging Vehicle details using SENDIG v3.1 public review completed – Leads updating following the feedback |
Project Members | Organisation |
|---|---|
| Annika Kreuchwig | Bayer |
| Bill Houser | BMS |
Cheryl Sloan | BMS |
Deepa Smant | Comcast |
Gen Sato | Eisai Co. |
Joseph Horvath | BMS |
| Matthew Crawley | Biocelerate |
Michele Dunleavy | Biocelerate |
| Nicolas Philippe | PointCross |
| Patricia Brundage | FDA |
| Rick Thompson | Janssen Research & Development |
| Steve Polley | GSK |
| Sue Dehaven | Sanofi |
| Todd Page | Eli Lilly |
| Wang Wenxian | BMS |