SS P08 13Jan2016 Standard Scripts Project 08 Meeting
From PHUSE Wiki
When: 13 Jan 2016
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Simin, Mohammad, Nhi, Nancy, Blisse, Mercy, Frank, Xiaoping, Rebeka, Wei, others I may have missed
- Upcoming March CSS
- Took poll on who is attending
- Nancy/Karin are working toward version 2 of the Central Tendency white paper to include ADaM specifications. The ADaM team to provide feedback. Target is to provide draft to the ADaM team and our White Paper Project Team early Feb.
- Mercy asked about WHO toxicity grading - Mary to ask internal SME within Lilly.
- Discussed AEs occurring between informed consent and treatment start. Generally, it seems uncommon to summarize these AEs. More common to have a listing of all AEs after informed consent with a flag designating whether it's TE. However, it varies quite a bit. Seems common to have a summary table for Medical History. We all agreed it would be good to have some general recommendations for this.
- Discussed PK studies and relation with AEs. Nhi used to be a PK Reviewer - usually requests a blood sample at the time of an AE but don't always get it.
- Discussed working model. We depend on volunteer work. Does the TransCelerate group depend on volunteer work? Mary to ask.
- Nhi and Mary will work on the poster for the CSS
- There was some brainstorming during a Steering Committee meeting about creating a project team to address data collection instructions (for AEs, meds, disposition, etc.) It sounds like Nhi would be interested in such a project. Mary to follow-up.
- Last revision by MaryNilsson,02/4/2016