HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-02-11

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 11, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Art Griesser (Promethues)

• Schematron can issue a warning if an Associated Message is referenced and there is no associated message.
• Schematron can issue an error if the Data File Type is “Cycled-Complex” and there is no referenced Associated Message.
• Is there a size limit for an XML file?
• The style sheet will display Associated Message data at the bottom of referencing file.
• Having all the Associated Messaged in one wrapper would not be as big of a problem as multiple messages in one file.
• The IG is ready for submission to HL7 and FDA web site. Waiting to find out what needs to be done for HL7.
• Changes to schematron (add to validation document): 1) Check for associated files if Cycled study is picked, 2) Check for code system names, 3) Check for Stability preferred terms (including the case), and 4) Why are eCTD file names failing? It should check just the file name for eCTD file. Teh attached file (http://gforge.hl7.org/gf/download/docmanfileversion/7233/10141/HL7DrugStabilityReportingValidationProcedures2-11-13.zip) is the HL7 Drug Stability Reporting Validation Procedures (1-28-13). Please look at and use track changes to edit and/or add comments.
• There will be no teleconference on 2/18/13, next teleconference will be 2/25/13.

Agenda for February 25, 2013 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
• Update validation document
• Outstanding issues