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 |
Snyder, FDA |
Mark Carfagna |
, Eli Lilly |
| Alex Pearce, PHUSE Project Assistant |
|
|---|
- Attended CDISC SEND F2F
- Currently collaborating on a White Paper
- Working on a Poster for PHUSE /FDA CSS 2022
Q4 2023 |
|---|
|
| Resources |
|---|
Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology Supporting the Use of SEND for the Implementation of Virtual Control Groups |
| Objectives & Deliverables | Timelines |
|---|---|
| Develop plans for a new, re-scoped project that will focus exclusively on applying harmonisation of SEND data to facilitate implementation of virtual control groups in toxicology studies | Q2 2023 |
| Continued work on consulting with other consortia to understand the critical data needed for virtual controls defining | Q3 2023 |
| Host a workshop at the PHUSE CSS | Q3 2023 |
Project Members
Cheryl Sloan
Deepa Smant
Gen Sato
Michele Dunleavy