SS P08 06April2016 Standard Scripts Project 08 Meeting
From PHUSE Wiki
When: 06 April 2016
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Russ, Simin, Nancy, Terry, Wendy, Nhi, Mercy, Wei, others I may have missed
- Summary of CSS white paper breakout sessions
- Develop action items related to CSS discussions
- Went over CSS white paper minutes
- Discussed action items:
- To develop ADaM for the C-SSRS, need to address copyright. Nancy will follow-up.
- Wei/Mary - Forward Craig Mallinkrodt's contact information to Nancy and Karin. He might be a good resource for the missing data topic. (There's a Missing Data Working Group that might have a lot of things to use as a reference.)
- The DILI conference slides should be available publicly. Those active in the hepatotoxicity white paper should review these.
- Mercy has action items related to being the liaison with the Script Repository group. Future agenda topic for our project team.
- Consolidated terms - Next step is to meet with the FDA MedDRA SME.
- Nhi mentioned that the FDA is working on updating ISS guidance. Nhi will begin networking.
- Last revision by MaryNilsson,04/11/2016