HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-08-15

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 15 2011

Attendees:

Norman Gregory (CVM), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Art Griesser (Promethues), Chuck Warner (Beckloff Associates), and April Daly (Lab Objects)

• For the ID for StudySponser (page 26-27), Manufacturer (page 39-40) and TestingSite (page 53-54) if more than one ID us used always list the DUNs number first, the DUNs number will be 9 digits and be prefixed with a "D" ( e.g., D123456789), and an FEI number will be prefixed by an "F" (e.g., F123456790). So all periods ".", dashes "-", and leading numbers "2." will not be used for a DUNs number or FEI number.
• The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6402/8603/eStability_Implementationguide_1_8_draft_8-15-11.zip) is the new version of the IG (1.8 draft (8-15-11)) with the changes (so far) based on the 8/15/11 teleconference, save file and change extension from .piz to .zip. Please take a final look for discussion.

Agenda for August 22, 2011 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
• Final changes to IG
• Schematron progress update
• eStabilty Validation Procedures document
• Outstanding issues