August 12, 2019 Meeting Notes

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June 17, 2019

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Elaine Thompson FDA
Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
Bob Friedman Xybion
Stephen MacMannis Pfizer
Fred Mura PDS
Anthony Fata Altasciences
Hanming Tu Frontage
Bill Houser Bristol-Myers Squibb
Atul Mishra Pfizer
Jared Slain MPI Research
Drashtti Vasant Bayer
Michael Muzyka MPI Research
Eli Miller Covance

Notes from last meeting:

Highlights from last week's CSS meeting:

  • There was interest in the SEND Data Factory from Lilliam Rosario for use in pilots
  • SEND Standard options (enable all three)
    • Read the PDF (current option)
    • Read the Excel file (next step)
    • CDISC Library API (aspiration)
      • Access would be nice, but we also need to understand if it would help with the desire to use it with pilots.
  • Bob - work on enabling this to pass the SEND validator
  • Kevin - create normal ranges.
  • Eli - reading the configuration files; then more advanced reading of the SEND standard.
  • later create synthetic dose response in the configuration files.

Changing STUDYID - Bill will complete his script for editing SEND datasets.

We agreed that it would be good to document key concepts that could help each other write better R code. The first question to decide is where to put this. On the GitHub wiki? on the PhUSE wiki? Some of the things that could potentially be placed there are things like:

  • How to create and interact with global variables
  • What libraries we have tried to use to create *.xpt datasets and our experience and recommendations.

Current Meeting Notes:

  • Discussed presenting SEND Data Factory at US CONNECT but no one can commit to attending at this time.
  • Discussed Hanming's work with FDA/CDER/Office of Business Informatics regarding the creation of an R Shiny app to that can generate simplified ts.xpt files
  • Kevin got permission to upload reference range data from LB domain based on historical control SEND data from FDA. Kevin is working adding correlation information to reference ranges.

Action Items:

  • Bob will fix the back-end of Hanming's TS generator app
  • Hanming will fix up the front-end of the app.