June 17, 2019 Meeting Notes

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June 17, 2019

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

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.

Next meeting is July 8, but Bill won't be available. He'll ask Kevin to lead.