HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-04-20

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

April 13, 2009

Attendees:

Norman Gregory (CVM), Terry Hardin (Perfitech), Mai Huynh (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Lisa Ylitalo (Eleos), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), and Holly Settles (Elanco)

  • I gave a presentation to FDA Premarket BRB on April 20th concerning style sheet and viewer development. It seemed to be well received and is under review.
  • Terry is hopeful to have something regarding the in-put tool by Monday (4/27).
  • These are the latest version of the style sheet from Catherine. 2009-04-20 Save all to the same directory. Double click on style_egBuild.xml and the other .xml files. It will come up in your default browser. Message from Catherine regarding the style sheet "I fixed the OOS problem and refreshed the colors. Since it will be two weeks, I did not want a broken example circulating for that long. One thing I forgot to mention is that OOS appears next to the OOS values because I am having difficulty with the bold font change. Was wondering what people thought of the "OOS" as the flag".
  • The Excel spreadsheet testcases.xls is available for download If you have examples of test cases or you see a problem with the test cases, please let Catherin know catherine.hosage-norman@sepracor.com. PQ data type is a value (25) and ST data type is text (pass).
  • Added hyperlinks to dummy PDFs (assay, dissolution, and impurity procedure) for Test in second table. Specification Code in first table also has a hyperlink.
  • Hover over some of the text under Component Tests in second table you get additional information which is coming from the Text attribute of the Specification element.
  • For ST data type (text), should have the Text attribute of the Specification element.
  • Need feed back on color scheme.
  • The style sheet does have embedded java script, some style sheet developers do not like to have embedded java script.
  • Someone in the WG did test the style sheet with a Mac and it worked fine.
  • I talked with Mead Walker regarding the change, more attributes with AssociatedStudy ( e.g, Text: ED). It is something we could change in the next release along with any other changes that are reveled by the testing of the DSTU. We need to make sure we document the needed changes.
  • There will be no teleconference on Monday April 27th, the next teleconference will be Monday May 4th.

Agenda for May 4, 2009 Teleconference:

  • Discuss the style sheet example.
  • XForm and input tools update.