SS 17Mar2015

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Agenda for Group Sessions in PhUSE/CSS 2015

Sunday Night Working Group Meet & Greet (5 pm - 7 pm) on 3/15/2015
  • Overview of working group (Mary)
  • Overview about Google Code (Hanming)
  • Update on scriptathons (Mike)
  • Update from each projects (Project Leads)
Monday Morning (3/16/2015)
11 am - 12 pm - the whole group
  • Background and Trends (Mat)
  • Overview of WG and Tour of the WG Wiki Pages (Mary)
  • Tour of Repository: structure and Index page (Hanming)
  • Updates for each projects within the working group (Project leads)
Monday Afternoon (3/16/2015) Breakout sessions
Monday 1:30 - 4:30 pm
  • White papers
    • Outlier/shift white paper - Any last comments before finalizing; discuss recommendation to add adjusted percentages to displays; discuss when to utilize CTCAE grading for shifts (currently asssumed these will be used only if a special topic lab)
    • Adverse event white paper - Time window for treatment-emergence definition, AEs leading to discontinuation - primary vs multiple reasons in collection and impact on display, when to use time to event, when to use number of events, when to use events per patient year, etc.
  • Platform: qualification process
    • Overview of the qualification process
    • Exercise the qualification process on a pre-selected script
    • Goals of the qualification/scriptathon
      • Clearly define what is qualification process and what means to be qualified.
      • Exercise the qualification process on a selected script
      • Develop other scripts into new phases
      • Qualification is on-going process and the qualified script could be re-qualified for its new version (expanded feature or coverage).
Monday (3/16/2015) Evening Scriptathon
Monday 6:30 pm ~ 11:30 pm
  • Every person will choose one or two scripts to move from its current stage to next stage such as from “D” to “T”
  • At least one or two persons to exercise the whole qualification process on additional script (moving from “C” or “D” to “Q”)
  • Track the progress on a matrix for the status and traceability
  • Scriptathon Detail
Tuesday Morning (3/17/2015) Sessions
8:30 am -12:00 pm
  • 8:30 – 9:00 am: Group Meet
  • 9:00 – 10:00 am: Meet with Therapeutic Area User Guide (TAUG) group on eSHARE; Feedback
  • 10:00 – 12:00 breakout
    • White papers
      • Hepatotoxicity white paper - feedback on displays recommended in the pre-draft
      • Questionnaire white paper - background on CDISC work and gap this white paper is filling, review some sample displays, recruit volunteers
      • TQT white paper - may not have any topics, but we will allow time to gather feedback on some sample displays if needed
    • Platform will work on creating documentation including tracking matrix
Tuesday Afternoon (3/17/2015) Group Meet
Tuesday 1:00 pm - 2:00 pm
  • wrap up together