January 13, 2020 Meeting Notes

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Jan 13, 2020

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
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:

  • Eli shared his enhancements to the SEND data factory
    • Download the CT only if it is newer, versioning CT.
  • Kevin is planning to add reference rages.
    • He will try to do unit conversions.
  • None of us understand how the files relate to each other nor a good understanding of the high level process. Some high level documentation in the readme would be helpful.
  • Kevin shared the Tox Summary app that he is creating.
  • Kevin will send out WebEx invitation to future meetings.
  • Kevin will share in the future their work at storing SEND data in a SQLite database.
  • Bill - will continue to investigate getting access to CDISC Library
  • 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)