Difference between revisions of "December 9, 2019 Meeting Notes"

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June 17, 2019<br>
Dec 9, 2019<br>
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Latest revision as of 14:09, 9 December 2019

Dec 9, 2019

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
Yes Bob Friedman Xybion
Stephen MacMannis Pfizer
Fred Mura PDS
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
Yes Daniel Russo Covance

Notes from today: Dan has joined us for the first time today. He will be working for the FDA creating predictive models using R. Bob shared his progress with the SEND data factory.

  • Give alert instead of error if insufficient selections are made
  • Create a DS domain
  • Create configuration files for PC and PP domain
  • Create output using the config files (partially done) for the animal domains.

Eli is planning to work on his contributions this weekend. Kevin will work on cleaning up Category and Units config and work on OM config. Bill - will investigate getting access to CDISC Library

Notes from previous meetings:

  • Discussed presenting SEND Data Factory at US CONNECT but no one can commit to attending at this time. - the deadline has passed.
  • Discussed progress made so far on the SEND Data Factory project and decided on directions for future work (outlined below under Action Items).
  • Kevin has been following 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:
LB - ranges to used

Bob -

  • Is there an argument in sourceline about reloading?
  • DUR_to_DAY function sometimes not loaded?
  • Why download button greyed out even after produce datasets selected?

to do

  • need assumption or configuration on how many days to create data for, for, LB, BW, PC, PP, etc.
  • Spelling fix: producting instead of producing
  • PCSPEC should have always PLASMA (as in configuration file)
  • PCSPEC should not be random


  • needed for sex, species, etc. for finding the appropriate values
  • general complete use of configuration files
  • Data Selections – does nothing it seems.
  • On produce dataset, shows “message” instead of a better text in progress bar, at first
  • Correlation between test results when generating test result data to allow a synthetic treatment effect to propagate among related test results.\
  • Synthetic time based changes for Body weights, adding in a body weight dose effect also useful.

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?

Data Factory Use Cases

  • Demonstrating data visualization tools
  • Create datasets as standards are approaching finalization for testing data that receives data from the standard
  • Creating large enough data sets for testing visualization or data loading tools for capacity testing
  • As example code to show
    • R script creation of XPT files
    • R script reading of the standard (CDISC library to be done? Still require a login but program would ask for it when you run it?)
    • R script reading of CT files (xls version)