SS P08 29Oct2013 Standard Scripts Project 08 Meeting
When: 29 October 2013
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Frank, Hanming, Simin, Wei, Kim, Nancy, Karolyn
- Discuss status of white papers
- Summary from PhUSE conference
Frank provided a summary from the PhUSE conference. They had record attendance (450) with >30 sponsors. There was a diversity of talks. Approximately 30 attended the CSS Working Groups sessions. Chris Decker collected names of those interested in joining. One comment - Europeans not sure they feel like they belong in these working groups. Something for us to address.
Discussed leads/co-leads for white papers. Everyone will think about who to ask. We need a co-lead for the 3rd and 4th white papers and a lead or co-leads for the 5th white paper.
Briefly discussed possible content challenges for the AE white paper - use of CTC vs Severity, need to discuss when to use exposure-adjusted vs time-to-event vs percentages, scope will likely exclude solicited adverse events.
Briefly discussed possible content challenges for the CCmed white paper - OK to not have any CCmed table, just use med info for narratives? Only include meds of interest? ATC codes - use to be required, now not?
Discussed the possible need for a narrative white paper. We don't think this will make sense to be covered in any of the currently listed white papers.
- Last revision by Jmbodart,10/13/2015