HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-11-16

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 16, 2009

Attendees:

Norman Gregory (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), and Diane Miller (Alpharma)

• The new version of the Stylesheet can be found at: http://gforge.hl7.org/gf/download/docmanfileversion/5347/6670/Nov19.zip
• Double click on the report and it opens a landscape view of the information, buttons at top to go to CVS view and back to report view. Can also choose what columns to display by un-checking column header box.
• Can export to Excel, will show all the columns no matter what is selected in landscape view. In Excel you can delete columns and select a column for copy and paste.
• In landscape view only Product Code every fifth row is shaded because of the amount of coding needed, will try in JavaScript to shade whole row. Since whole columns can be deselected this function may not be necessary.
• From eCTD rules, an OID is not a recognized file name for FDA.
• Need examples of how Associated Studies are formatted (in IG and how to Guide).
• The Word document “eStability Input Tool - Input Screen Tips.doc”can be found at: http://gforge.hl7.org/gf/download/docmanfileversion/5341/6649/eStabilityInputTool-InputScreenTips.doc. Please take a look at it for discussion at next teleconference.
• The Input Tool is ready for testing. It can be found at https://www.estability.org then click on wiki at top of page and it is at the bottom, file name SMIT0942.zip and the expiration is 1/1/2010. There is also a Word file ”input_tool_observations” that documents other known issues. You need Microsoft.NET framework, version 2 or higher (most current is 3.5) for the Input Tool to work.

Agenda for November 23, 2009 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Discuses the attached document “eStability Input Tool - Input Screen Tips.doc”.
• Looking at Input Tool using Adobe connect to work on what information to put in help fields.