HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-03-23

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 23, 2009

Attendees: Norman Gregory (CVM), Terry Hardin (Perfitech), Jonathan Cook (CDER), Mai Huynh (CVM), Elizabeth Cormier (CVM), Amy Malla (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Lisa Ylitalo (Eleos), Mike Yang (ScienTek Software), Diane Miller (Alpharma), Holly Settles (Elanco), Teresa Lucas (Eli Lilly)

  • XForm will not be available until the end of April from Global Submit. The WG could develop and XForm for use if we fell waiting till the end of April is to late. It is possible to have links to software, but we cannot guarantee that we can point to their software from FDA DSC webpage. Another option is a posting it on an HL7 wiki
  • It is also possible for the WG to act as a beta tester for software developers developing input tools. Need peoples thoughts on this.
  • There will be a presentation to FDA Premarket BRB (Business Review Board) under the BIB (Bio-Informatics Board) on April 6 regarding the development of a style sheet for eStability.
  • Catherine gave a demonstrate with a PowerPoint presentation on opening eStability.xsl file in Notepad or WordPad. WordPad gives a better presentation of the file. Save the following files to a folder named "style". will contain the sample messages, stylesheet, cascading style sheet, and How to Read eStability.xsl PowerPoint presentation. Extract all to the same directory. Double click on style_egBuild.xml and the different test files
  1. test1_M.xml
  2. test1_MR.xml
  3. test1_MRO.xml

It will come up in your default browser.

  • Attached is an xml file provided by Mike Yang that can be opened in WordPad or Notepad. WellFormatted.xml When opened it has an easier format to read.
  • Style sheet should display the results without units (e.g., mg), just the value. The acceptance criteria will have the units.
  • Style sheet should display the vales and not the level (e.g., for dissolution display 12 values for level 2 and 24 values for level 3), will not display level 2 or 3.
  • Message allows for 3 levels of testing and IG constrained it to 2 levels. If level 1 has no value (N.A.), and there are values at level 2, can it bring level 2 values up to level 1 (e.g., level 1 is microbial limits, and level 2 are the actual test).

Agenda for March 30, 2009 Teleconference:

  • Discuss the style sheet example.
  • XForm and input tools next steps.