SS P08 20Jan2015 Standard Scripts Project 08 Meeting
From PHUSE Wiki
When: 20 Jan 2015
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Mohammad, Helsinn, Sheryl, Rebeka, Wei, Nancy, Karolyn, Simin, Aiming, Frank, Terry
- CSS Preparation
- White paper updates
- PhUSE CSS - Breakout session planned for our project, 4 posters planned for our WG
- PharmaSUG - 2 presentations/posters planned for our WG (1 general, 1 on qualification process)
- We discussed version 2's of our completed white papers - probably next year
- We do have editing support for our white papers (via Lilly)
- White Paper Updates
- Outliers/Shifts - working on final version. Will discuss during breakout session. Mary to ask Steve/Mat about FDA review.
- Adverse Events - working on next draft. Will discuss during breakout sessions.
- Hepatotoxicity - Draft to white paper project team coming. Will discuss during breakout sessions.
- QT Studies - Draft to white paper project team coming soon.
- Questionnaires - Draft to white paper project team coming soon.
- Special topics - Wei/Mary will likely lead after outlier/shifts done.
- Last revision by Jmbodart,10/13/2015