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

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

April 6, 2009

Attendees:

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 eStability.org 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 DPreview.com, 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.