HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-02-25

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 25, 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), and Art Griesser (Promethues)

• The style sheet will display Associated Message data at the bottom of referencing file and the version number will be above the Associated Message data and after the data table.
• Made changes 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), 4) directions for file name including eCTD restrictions, 5) corrected the schema form V01 to V02, 6) added directions for AssocoiiatedStudy(s) if referenced, 7) added version history, and 8) added footer. The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/7256/10192/HL7DrugStabilityReportingValidationProcedures_0_2_final_2-25-13.zip) is the HL7 Drug Stability Reporting Validation Procedures_0.2_final_(2-25-13). Please look at and use track changes to edit and/or add comments.

Agenda for March 4, 2013 Teleconference:

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