November 18, 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
Yes 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
Yes Eli Miller Covance

Notes from last meeting:

  • 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.

Current Meeting Notes:

  • Discussed progress made so far on the SEND Data Factory project and decided on directions for future work (outlined below under Action Items).
  • Kevin demonstrated an R Shiny app that he is developing to assess the population of selected SEND variables and parameter codes across a large collection of SEND datasets.
    • Kevin will follow up with Lou Ann Kramer about whether it is okay to post the excel version of the SEND IG to GitHub as this is a dependency of his application.

Action Items: Eli LB - ranges to used

Bob - why error if no selections, is the durtoday now working? why "download" greyed out (not be grey after product is selected) PC - should not have random units PP - not existing DS - not existing Fix spelling of configurration

Kevin - collect OM ranges historical control incidences for cl, ma update LB ranges and add LB cat

also to do: DD - not existing cl,ma - assumes numeric, should be categorical, what observations? mi -there is CT, should be used DD - not existing

future: ts,tx,ta,te - OK for now? bw - seems not using the element lengths does it pass pinnacle validator?