HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-02-13

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 13, 2012

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.)

• Questions for XSLT 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 XSLT 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.
• Questions for XSLT Form: There will be a choice between a report and report revision.
• Questions for XSLT 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 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 4.4.3.2). The IG referes 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.
• There will be no teleconference on February 20, 2012.

Agenda for February 27 2012 Teleconference:

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