SS P08 02Feb2017 Standard Scripts Project 08 Meeting

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Meeting Record

When: 02 February 2017
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Wendy, Nancy, Raphael, Simin, Ping , Wei, others I may have missed

  1. Agenda for break-out sessions
  2. Align on goals for 2017
  3. Who's going to CSS


  • Topics for break-out sessions
    • Mary will talk to Terry about whether there's time needed for the hepatotoxicity paper at the CSS
    • Brainstorm additional ways to get the word out.
    • Version 2 of white papers - Define process. Gather feedback before drafting version 2, or just send version 2 for review? We can discuss this at the next ADW meeting if there's time.
    • Medications topic - Offline meetings - not as CSS
    • Collection Instructions - Monday afternoon 2:30-4. Tuesday morning 10-12. Need a liaison? Should we make it a joint session instead. Maybe 2:30-4? (Need to be ready where are issues are.) Mary will talk to Jane/Todd.
    • How to move toward this standardization effort. Need a strategy of scope. Might need a strategy on what we would want required versus "optional". Will regulatory ever create a guidance? Will guidance be more on content and not so much on the display - maybe just certain elements (eg, results dataset - overlaps with another project team). Short term - Will RT include something in the Clinical Reviewer Template?

CDISC started 1997 - first SDRG about 2010 - requirement is 2016. We can start this topic at the CSS, and will continue in our meetings.

  • Goals for 2017
    • Hepatotoxicity - Done in 2017 (at least by Feb 2018)
    • Labs/Vitals/ECGs version 2 - Updated draft in 2017
    • Demog/Disp/Med version 2 - Updated draft in 2017
    • Questionnaire Data - Draft in 2017
    • AESIs - Draft in 2017
    • TEAE definition - Draft 2017
  • Action item: We can create an announcement with these 6 white papers and ask for volunteers. Hope to get people with experience with the topic, and leadership skills to know how to run these types of projects. Target for Feb 23rd newsletter. Draft should be ready Feb 17th-ish.

    • Last revision by MaryNilsson,02/2/2017