HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-05-04

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

May 04, 2009

Attendees:

Norman Gregory (CVM), Terry Hardin (Perfitech), Mai Huynh (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Lauren Merrill (Genzyme), and Maje Nazim (Genzyme)

  • Jason has started on XForm, any of the xml files in the style sheet zip files can be used as instances, representative manufacture can be a sub-contractor.
  • Small problem with the visual layout of the in-put tool, should have something in a week or so.
  • FDA is looking at doing the style sheet development, will use what the Working Group has developed and work from that.
  • The style sheet has the heading "Manufacturer", "Manufacturing Site", and "Assigned To". I check with the current vocabularies to see what terms are being proposed. There are no term for "Manufacturing Site", and "Assigned To" so we have flexibility with those. There have been many terms being looked at for "Manufacturer", such as "Firm", "Sponsor", and "Applicant". It looks like "Firm" is the choice at this time. I think we are fine leaving it as "Manufacturer" (see next point).
  • Where the heading name is different than the XML tag, will have hover over showing the tag name the heading is coming from.
  • The units in the child element will be removed.
  • Hover over some of the text under Component Tests in second table you get additional information which is coming from the Text attribute of the Specification element.
  • Looking at making the pop ups narrower so they don't cover as much area.
  • For the next four month period there will be no teleconference on Monday August 3rd and Monday September 7th. We will have the teleconference on Monday May 18th and Monday May 25th, both of these will probably be updates and short.

Agenda for May 11, 2009 Teleconference:

  • Discuss the style sheet example.
  • XForm and input tools update.