HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-10-25

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

October 25, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Jennifer Rice (Alpharma), Art Griesser (Promethues), and Josh McDade (Promethues)

• The new version of the IG (v1.6) was approved by RCRIM and the necessary forms sent to HL7 so it can be post on the HL7 site.
• The current information has been sent to www.eStability.org so that site can be updated.
• The current information has been updated on the FDA.gov Data Standards Council page.
• We will try to get the information posted on the CVM eSubmitter page also.
• Working on updating the FDA.gov Data Standards Council page with a new layout and a statement that this is highly recommended for CVM by March 2011 and for CDER by July 2011.
• There are two levels of test, at level one there is no pause quantity or sequence number. Only at level 2 is there a pause quantity or sequence number.
• The first pass of the schematron (business rules) will be the optionallity of the attributes, other rules will be developed later.
• Attached is the final version of the Stylesheet, save to computer, change the extension from .piz to .zip., extract to a folder, and read the file “ReleaseNotes[1.5].txt” and follow the directions for changing the file name from “eStabilityWin.js.txt” to “eStabilityWin.js” and for changing the "eStabstyle.css" file to display in the color you want. You an also get it from https://www.estability.org then click on wiki at top of page and it is in the middle, file name eStablilityStyleSheetFinal.zip.
• We need to find out where the style sheet and the coreschemsas and multicacheschemas can be stored and posted. FDA.gov Data Standards Council page?
• I will contact Dr. Woody Beeler and Mead Walker and ask them to be on the call next week.

Agenda for November 1, 2010 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Discussion with Dr. Woody Beeler and Mead Walker regarding changes to the HL7 core schemas that affect our schema.
• Schematron progress update