HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-11-30

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 30, 2009

Attendees:

Norman Gregory (CVM), Mai Huynh (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), and Jennifer Rice (Alpharma)

  • Started looking at the User Guide for the Input Tool.
  • The XML file validation is based on the schema, there is a second level of validation for the FDA business rules (schematron).
  • The Input Tool needs to have a radio button to select what level of validation you want (validated to schema or to schema and schmatron).
  • At the end of the Use Guide for the Input Tool or attached to the document or in a directory need to have examples of valid XML files for product and substance, which can then be opened using the Input Tool.
  • Need cycled study example.
  • Please start trying to use the Input Tool and document any issues. 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 December 7, 2009 Teleconference: