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HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-04-06

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Revision as of 12:42, 13 May 2009 by Trippes (talk | contribs) (New page: Return to Drug Stability Reporting ==HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes== '''April 6, 2009''' '''Attendees:''' Norman Gregory (CVM), Terry Har...)
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Return to Drug Stability Reporting

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

April 6, 2009


Norman Gregory (CVM), Terry Hardin (Perfitech), Elizabeth Cormier (CVM), Amy Malla (CBER), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), and Holly Settles (Elanco)

  • Scheduled to give presentation to FDA Premarket BRB on April 20th concerning style sheet and viewer development.
  • The Input tool Terry is developing can be on the link from the FDA Data Standards Council web page. Jason (Global Submit) has started collecting information for the XForm.
  • The Associated Message also references the lot number and storage condition.
  • Files that begin with the number 1 will not work, reserved number for browser.
  • Need feed back on color scheme.
  • Hover over a result, gives the test date and any comments.
  • Working on the style sheet to display a flat file also (like Clark/Ya model), will show all values that the average is based on.
  • You can optimize the colors of your monitor by going to, click on one of the camera reviews and go to the bottom and look at the grayscale chart.
  • If the decimal places are varied in the set of results, always display with the most.
  • If value has to be a number and the result is ND, report to decimal place (e.g., 0.00 not just 0) and in comment put ND.
  • Need examples of XML cases on different types of values.
  • Will contact Mead to have on the call April 13th regarding more attributes with AssociatedStudy( e.g, Text: ED).

Agenda for April 13, 2009 Teleconference:

  • Talk with Mead Walker?
  • Discuss the style sheet example.
  • XForm and input tools.