SS P08 15April2014 Standard Scripts Project 08 Meeting

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Meeting Record


When: 15 April 2014
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Terry, Nancy, Kim, Wei, Christina, Karolyn, Jane
Excused:

Agenda
  1. PharmaSUG
  2. Wiki Pages for each white paper
  3. PhUSE Oct Annual Meeting - Scriptathon
  4. Discuss progress for each white paper

Minutes

PharmaSUG (June 1-4) - Nancy and Terry will be in attendance and presenting the Working Group paper. Nancy will organize the creation of the presentation and will send for review. There will be a Scriptathon there with the CTSPedia graphs as targets.

We reviewed the structure of the Wiki pages for the white papers. White paper leads should keep their page up-to-date. Let us know if you're having problems with updating. The Wiki account is different than the PhUSE account.

PhUSE Annual Meeting - We will be having another Scriptathon. We are assuming we will have targets from these white papers for that meeting!

Discussed each white paper's progress:

  • Central Tendency - revision likely next year
  • Outlier/shifts - draft ready for review probably May or June instead of April
  • AEs - not much progress yet. Discussed relatedness a little - still waiting to see if there is standard collection. It appears (to be confirmed) that Japan requires a table that has TEs and related TEs side-by-side (instead of one table after another like many of us do). Something to follow-up on and consider.
  • Demo/Disp/Med - Draft should be ready by the end of April or early May.
  • Liver - Next step is to find someone who attended the Liver meething that Mary Doi was telling us about. Terry and Mary will work on thisl
  • PK - Done - no update
  • QT Studies - This one will put collaboration with TransCelerate to the test!

Discussed collaborations with TransCelerate in general. Also need collaboration with the ADaM meta-data team. Nancy can be our link with the ADaM efforts. Jane is involved with the TransCelerate TB standard. We can collaborate on possibly getting that to include ADaM and TFLs. Some of our shells may help TA teams. Wei Wang is a good person to involve for any proposed figures. She's involved with good visual display practices. Vision might be to have TransCelerate's deliverables be end-to-end for therapeutic areas. Our deliverables can be "Across TAs" end-to-end. Collaboration is a topic of interest for the CSS Steering Committee.


  • Last revision by Jmbodart,10/13/2015