Mar 30, 2017 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

March 30, 2017

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Elaine Thompson FDA
Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
Bob Dorsam FDA
Yes Bob Friedman Xybion
Chris Eley Pfizer
Yes Stephen MacMannis Pfizer
Yes Fred Mura PDS
Yes Anthony Fata PDS
Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Carol Gleason Bristol-Myers Squibb
Atul Mishra Pfizer
Peter Scaefer Validated Cloud Applications
Yes Mark Pinches Lhasa

Meeting time - we will meet at 10:00 eastern on every other Tuesday starting today March 30, 2017. Objectives for this coming year:

  • Plan to prepare now for a poster for next year CSS
  • Work on a significant project for next year.
  • Potential new projects: (We each voted for the top 2. An exclaimation point marks each vote)
    • Pre-defined standard tables, graphs, and figures using examples from some other source.
    •  !Improve the crona tool by eliminating the need for Excel. ()
    •  !!!!!Create an R Shiny Body weight analysis tool.
    • Searchable SENDIG using *.owl. Bob spoke with Barrie Nelson if this could be updated using CDISC's SENDIG3.1
    •  !!SEND to tumor.xpt converter with synonyms
    •  !!Conversion between *.xpt and Excel
    •  !!Tool to obscure sensitive information

We decided to create an R Shiny tool for interactive body weight analysis tool to eliminate the need for exchanging BG tables.

  • Permits the user to specify the input files (BW, DM, and possibly TX, TA)
  • The user selects the intervals
  • The tool creates BG table and graphical view and a tabular view
  • User selects which ANOVA and/or other group stats

In our next meeting Kevin will guide us through creating the initial user interface.