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 |
|---|---|---|---|
| Liz Ness | Pull up example for when immunological response could be used | Jul 10 | Open |
| Susan Pannoni | Research immunological response - FDA considers this under biologic agents | Jul 10 | Open |
| Liz Ness | Tumor pathologic response - Uncover form and possible value list. Lymphoma SME? | Jul 10 | Open |
| Working Group | Review list of values for current response by disease distributed by Eleanor Leung-Hollins | Jul 10 | Open |
| Susan Pannoni | Follow up with outstanding action items list to see if anything still to be done | Jul 10 | Open |
| Working Group | Review the new CDE Spreadsheet for the next meeting (ensure it covers the correct definitions and terms are correct) | Jul 15 | Open |
| Mary Cooper / Susan Pannoni | Look into CDISC to see their responses and match what is in our spreadsheet | Jul 10 | Closed |
| Susan Pannoni | Add column for comments/thoughts to new CDE tab(s) to note reasons for not using elements | Jul 10 | Closed |
| Group Members | Find any disease elements that are not already represented | Ongoing | Closed |
| Diane Paul | Send some examples of QOL performance status | Jul 10 | Closed |
Working Group Documents
- A051103 Lymphoma
- A061202 Myeloma
- Immunological Response Guidelines
- Pathological Response (Updated July 1)
- NCI Leukemia Response Status (Updated July 10)
- 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
