HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-11-16
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
November 16, 2009
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.
- 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.
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