SS P08 08Oct2014 Standard Scripts Project 08 Meeting
From PHUSE Wiki
When: 08 October 2014
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Mohammad, Christos, Frank, Terry, Mercy, Aiming, Simin, Nancy, Ann, Wei
- Hepatotoxicity white paper
- We might want more on central vs local labs - We believe medical opinion is to keep separate.
- If observe a value >x, a CRF is turned on and local follow-up data is collected.
- Table 7.1 - Keep p-values on each row
- Wording of "haptotoxicity signal" - to Hepatic-related
- Keep total column off (only in demographics)
- Figure 7.1 Wei will send latest figure to Terry
- Table 7.3 SMQ table - make consistent with AE white paper. Figure instead? We don't think so.
- Figure 7.2 (patient profile) Wei will send her version of hepatic patient profile
- We should expect a debate on individual study versus integrated
- Time to event - concerns with this for scheduled things like labs (different than AEs)
- Last revision by Jmbodart,10/13/2015