November 18, 2019 Meeting Notes

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
  • https://geotiger.shinyapps.io/07_genTS/
• 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?