SS P08 15Sept2017 Standard Scripts Project 08 Meeting

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Meeting Record

When: 15 September 2017
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Lauren
Attendance: Lauren, Lisa, Terry, Russ, Wei, Cathy, Karin, Mohammad, Nhi, Mercy, Jared, Julie, Aiming, others I may have missed

  1. White paper walkins


  • Medication Displays Document Discussion
    • Draft of version 2 Likely to stick with preferred term format as we are not sure of the general concomitant table extra work to produce a new ADaM data set to produce the by ingredient table. We will still have text to show that we considered this table the text will imply for most studies the preferred term is fine
    • White paper will encourage to have data stored in a way to make anyone of the ways of looking at medication available
    • Karin- CDISC does have occurrences data set sub team in ADaM
    • Preferred term and ingredient term are the preferred tables within the team
    • Wei- ADaM must consider making the ingredient table available
    • Nhi- FDA working on displays and the safety review
    • Nhi- group to come up with recommendation for a run of the mill application however showing the ATC code could be useful. Show in the paper where it would be helpful to use the ATC code display and show the data in a certain way
    • Mary- Should have ATC codes within our data so that it can still be an option
    • Mary- Be clear on the pros and cons of the tables make sure that the user of that display knows the pros and cons
  • How to collaborate with the ASA
    • Potentially collaborating with the ASA and other groups who have an overlap in interests (ASA programming group, ASA Safety monitoring group and a DAA group)
    • Determine where to position our White paper and consider a joint White paper (co-sponsored white paper run this past the steering committee)
  • Update on white papers
    • Medication White paper is the highest priority (end of this year for public review before the B3 format becomes live)
  • Liver white paper
    • Discussed whether summarizing 3x baseline for liver is becoming more standard. Mentioned in a guidance. We need to at least address this in the liver white paper - either recommend it or explain why not recommended.
  • Mohammad’s Link
    • ASA safety monitoring group Webinars if you are interested in attending

    • Last revision by MaryNilsson,12/15/2017