HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-03-30

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 30, 2009

Attendees: Norman Gregory (CVM), Terry Hardin (Perfitech), Mai Huynh (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Lisa Ylitalo (Eleos), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Holly Settles (Elanco), and Amy Gilooly (Sepracor)

  • WG does want Terry to develop an XForm or input tool that will be free and put on the eStability.org site and will still try to get it on the FDA DSC webpage under Stability Data Standard.
  • WG is acceptable to act as a beta tester for software developers developing input tools.
  • The following files should be saved to the same directory. StyleMarch30 Double click on style_egBuild.xml and the other .xml files. It will come up in your default browser.
  • The specification section contains any text associated with the acceptance criteria.
  • The intervals are sorting on number.
  • Hyperlink to specifications in Specification Code.
  • Hyperlink to Associated Messages.
  • How will hyperlinks work with eCTD/RPS.
  • Need more attributes with AssociatedStudy( e.g, Text: ED).
  • Have to click the File ID (OID) to see Lot # and storage condition, would be preferable to display the Lot # and storage condition that would point to File ID.
  • Will contact Mead to have on the call April 6th.

Agenda for April 6, 2009 Teleconference:

  • Discuss the style sheet example.
  • XForm and input tools next steps.