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Latest revision as of 22:14, 15 February 2012

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 13, 2012 - CORRECTED

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), and Howard Shatz (Data Conversion Laboratory, Inc.)

  • Catherine is using VB.NET, she started with XSLT Form, but found you could not save files with JavaScript.
  • Questions for VB.NET Form: Things like StudySponser and AssociatedStudy have and assigning Authority in the example in the IG, but the root ID does not. We will make the assumption that the StudySponser assigningAutority is the same for the for each example message.
  • Questions for VB.NET Form: Empty components (test intervals) will be created with no data to the expected end point (e.g., Protocol goes to 48 months and the stability study is for 24 months, there will be empty components for 36 and 48 months. Mike Yang made additional comments during the meeting: Must make sure that the XML file that contains empty components for testing intervals without data will be valid against schema and will pass the eStability Validator validation. The original statement may give the readers an impression that this is already a done deal. In reality, testing is required.
  • Questions for VB.NET Form: There will be a choice between a report and report revision.
  • Questions for VB.NET Form: What to use for Time units? Could use a GUID to covert all time to the same units when converted to XML and the stylesheet would give a choice on what time unit to display. This subject was discussed and deemed impractical in the current pharmaceutical environment for reasons of (1) FDA may not know the intended time unit by the submitter; and, (2) the current stylesheet cannot choose a different time unit. Or the submitter would have a choice box of common time units (Y = year, M = month, W = week, and D = day; for designating time a T with a H = hours, M = minutes, and S = seconds) (from ISO-8601 Section The IG refers to the ISO 8601 format.
  • Need to change IG example for AssociatedStudy with no assigning Authority indicated and add recommendation to create empty Components (test interval) to the maximum time to be stored on stability. If the IG will be updated, Mike Yang suggested that the XML file example in the IG be submitted to the current eStability Validator to ensure that the example is fully validated against both schema and schematron. The empty components still need to be tested (see above).
  • There will be no teleconference on February 20, 2012.

Agenda for February 27 2012 Teleconference: