Feb 11, 2019 Meeting Notes

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Feb 11, 2019

Present First Name Last Name Affiliation
Yes 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 SNBL
Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Atul Mishra Pfizer
Jared Slain MPI Research
Drashtti Vasant Bayer
Michael Muzyka MPI Research
Regrets Eli Miller Covance

Follow-up action from previous meetings:

  • CDISC has told Bill the SHARE IPA will be accessible in Q1 2019 and will be accessible to this team.

Today's topics:

  • Eli asked if anyone would be interested in writing the FDA validator rules as an R package? This would be a medium effort project that I think would help people create or enhance how they currently validate their datasets. The team doesn't want to hinder you. Bob wouldn't be able to participate since it would be in conflict with his day job. If pinnacle21 actually delivers on a tool, it would be nice to build on that.
  • Many of us will be joining the PhUSE US Connect meeting: Bob, Lou Ann, Hanming, Bill, Kevin, Eli.
  • Bob shared his progress with the Data Factory. He will upload what he has to github. Kevin and Eli have expressed an interest in participating.
  • Next meeting, Bill will present on his xpt_txt script.
  • Bill will forward to Tony his plans for continuing development on xpt_txt for him to evaluate what parts are interesting to him.