HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-08-17

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 17, 2009

Attendees:

Norman Gregory (CVM), Tim Lee (CBER), Amy Malla (CBER), JoAnn Ziyad (CFSAN), Chima Ovinna (CFSAN), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Jason Rock (Global Submitt), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), and Diane Miller (Alpharma)

  • Jason did an XForm demo. There is a FAQ and support site. To get to the XForms you can try the attached file (change .piz to .zip), this might work, if you have problems you should try the following link from the fda.gov web site: http://www.fda.gov/ForIndustry/DataStandards/XForms/default.htm this also has other good information.
  • The XForm has nine (9) tabs for the different information.
  • When filling out the XForm all the sites listed under "Organizations" need to be referenced under one of the other tabs before saving or the organizational information for that site will not save.
  • For discussion next week everyone should download the XForm and try and create a real message using real data and document any issues.
  • If you are reporting stability data for an API intermediate or unrefined API you should treat it as an API, if it it an unrefined finished product treat is as a finished product.
  • Mike Yang and I are checking the XML file for closure codes, I will also check that the style sheet has a place for any mandatory field as stated in the IG and Mike Yang will look at the XML.
  • Attached is an Excel spread sheet named "Revisions" that list all the changes and information that should be in the pertinent documentation.
  • The "User Guide" document needs to make sure we point to the code lists both from SPL and internal from the IG, there are codes for containers in both places.

Agenda for August 24, 2009 Teleconference: