HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-11-08

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 8, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sunovion), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories) and Josh McDade (Promethues),

  • Schematron was generating errors if an element was required by FDA (optional for HL7) and the element was not in the file. The schematron will treat required and optional elements for FDA the same way, the element can be listed with a null value or the element not listed at all and an error message will not be generated.
  • Componet7 from TestDefinition is mandatory only if there is a second level test form the first level. If there is only a first level test, then there is no Component7. I sent Josh a table of the first and second level test in example_message.xml file.
  • The Style Sheet will have version number (1.6) and release date at the bottom, also will correct the misspelled "Time Poinit" in flat file table for "select Test for Separate Display".
  • Do we wan the validator (schema and schematron) on the FDA Data Standards Council page or point to the developers web page for validator like for SPL.
  • Can the coreschema and multicacheshemas be on the FDA Data Standards Council web page like SPL (called "FDA SPL Schema for Implementation") or are they HL7 property? I will ask HL7. The style sheet can be on the FDA Data Standards Council eStability web page.
  • We want to try and set up a meeting with vendors again. Try to get it on the Pharmaceutical Stability Discussion Group (PSDG) web page,http://www.pdgroups.org/psdg (Mike Mlodzik might be able to help with that) and with AHI, DIA and PhRMA (Ed Tripp, might be able to help with DIA and PhRMA). The agenda need to have FDA timelines with dates for when it will be required (this could be a problem).

Agenda for November 15, 2010 Teleconference:

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