SS P08 26May2016 Standard Scripts Project 08 Meeting
From PHUSE Wiki
When: 26 May 2016
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Russ, Simin, Wei, Mohammad, Xiaoping, Karolyn, Nancy, Mercy, Sammy, Nhi, Terry, others I may have missed
- AE White Paper
- Discussed that the TFLs in the white papers are "examples" Thought about using color for portions that are optional, however the entire display is really optional. The decision is that we would try to make it clear that TFLs are examples in a different way than coloring (e.g., say "Example" in the title).
- Discussed that we want to keep CIs in the examples even though they are optional (everything is optional - we're choosing to show an example that includes them)
- We should try to get permission to upload the CIOMS guideline that is no longer in print
- CDASH worked on a recent implementation guide. We should make sure we're not inconsistent with that. (Mike Ward is a contact within Lilly. Nancy is a contact.)
- Discussed CTCAE terms. CTCAE terms are consistent with MedDRA LLTs (as of a couple years ago?). Not all AEs have CTCAE grades.
- Discussed common AE figure. We can mention that a table might be preferred if AE groupings is a big issue for a compound.
- Future structure of white papers - try to handle some topics as separate documents (e.g., time).
- Last revision by MaryNilsson,07/1/2016