Dec 10, 2018 Meeting Notes

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Dec 10, 2018

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
Anthony Fata SNBL
Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Atul Mishra Pfizer
Yes Jared Slain MPI Research
Drashtti Vasant Bayer
Michael Muzyka MPI Research
Yes Eli Miller Covance
  • SEND data factory
    • The clinical factory has not progress much, Bob has started creating list setup questions to define the parameters of the datasets.
    • Bob is currently working on the framework and will be eager for assistance once this is ready.
  • PhUSE Connect
    • Wondering if Kevin needs help preparing for any presentation at this meeting.
    • Bill will ask him.
  • Safety Pharm
    • Jared indicated the CDISC SEND team is hearing the EG domain may contain important data in addition to CV and RE.
  • XPT editing
    • Bill shared that he having difficulty writing to XPT. Eli mentioned he uses rio. Bill said he will try this out.

Follow-up action from previous meetings:

  • Jared received permission to share his Excel to XPT script. He is planning to contribute it to ..\phuse-scripts\trunk\contributed\Nonclinical\SAS\Utilities - SEND_easyExcelXPT. He placed it there but it isn't yet visible to others.
  • Bill will check on when SHARE IPA and/or OWL files will be accessible to this team.