The Response/Procedures and Results working group focuses on a response to a study’s intervention, including procedures and results. The content includes any kind of intervention where response is measured.
Meeting Logistics
All working group Teleconference Information, Web Session Details, and Meeting Schedules
Active Action Items
| Owner(s) | Action Item | Due Date | Status |
|---|---|---|---|
| Group Members | Find any disease elements that are not already represented | Ongoing | Ongoing |
| Working Group | Review the new CDE Spreadsheet for the next meeting (ensure it covers the correct definitions and terms are correct) | Jun 26 | Open |
| Mary Cooper | Look in the CDE browser and see if the terms are used by CDISC | Jun 26 | Open |
| Susan Pannoni | Add column for comments/thoughts to new CDE tab(s) to note reasons for not using elements | Jun 26 | Open |
| Liz Ness | Pull up example for when immunological response could be used | Jun 26 | Open |
| Susan Pannoni | Research immunological response - FDA considers this under biologic agents | Jun 26 | Open |
| Anne Tompkins & Liz Ness | Tumor pathologic response - Uncover form and possible value list. Lymphoma SME? | Jun 26 | Open |
| Cathy Rankin | Forward pathologic response to Susan Pannoni | Jun 26 | Open |
| Diane Paul | Send some examples of QOL performance status | Jun 26 | Open |
| Neesha Desai | Change the July 3rd meeting to Monday July 1st | Jun 26 | Open |
| Susan Pannoni | Touch base with Dianne on how to handle the Response Method CDE | Jun 27 | Open |
Working Group Documents
- Round 5 Response-Procedure Results Document - with CDEs (Last Updated June 26)
- COH1024V03
- COH1059
- COH2004
- COH2077
- COH2331
- COH2649
- CRFWG_roadmap slide
- Solid tumor evaluation form_GOG
