HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-01-25

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

January 25, 2010

Attendees:

Norman Gregory (CVM), Norman Schmuff (CDER), Elizabeth Cormier (CVM), Amy Malla (CBER), Tena Wei (CDRH), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Yang (ScienTek Software), and Diane Miller (Alpharma)

• We will ballot the eStability message with the changes (adding Text ED attribute to AssociatedStudy and expirationTime attribute to Substance) as a normative ballot for the May HL7 meeting. The deadline for notification of intend to ballot is 2/28, the initial content deadline is 3/7, and the final content deadline is 3/28, ballot preview period is 4/5 through 5/9.
• The common product model (CPM) has a class for Product, Substance, and ProductInstance. Product has attribute for expirationTime, ProductInstance can be the product or the substance and has attribute for expirationTime, Substance does not have attribute for expirationTime. The Substance part of the CPM is being remodeled and we can get the attribute for expirationTime added then. The CPM also has a class called Container and a class called PackagedProduct, PackagedProduct has attribute for capTypeCode but Container does not. Never did get a good explanation why that is. Since the CPM is derived from the SPL model we can add comments or vote negative when SPL is balloted again addressing these issues.
• The Tool Tips in the new version of the Input Tool appear with a timeout period (this is normal), they reappear if you hover over the field again.
• In the new version of Input Tool using “Tools” you can select “Options” and select a radio button for “None”, “FDA”, or “HL7” and the required fields will be highlighted. This should highlight the mandatory fields not the required fields, I will check and make a list for Terry for the next version.
• Add an Undo button to the Input Tool so a mistake is made you can undo it.
• We had length discussion regarding cycled studies. Is a one time cycled study one report with a description of the storage conditions or many reports associated with a sequence number? If one time cycled studies are a single report with the storage condition described and a cycled study that is happening at different time points (e.g., in use study after 12, 24, and 36 test station) are separate associated reports with sequence numbers we need to explain this very well in the IG and Input Tool User Guide.
• Attached is the newest version of the Stylesheet, save .zip file to computer, extract to a folder (see attached http://gforge.hl7.org/gf/download/docmanfileversion/5440/6863/estability-Jan25.zip). 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 establility-jan25.zip.
• Please start trying to use the Input Tool and document any issues. It can be found at https://www.estability.org then click on wiki at top of page and it is at the bottom, file name SMIT-0950.zip and the expiration is 3/1/2010. The first time opening will ask for license key that is provided on the wiki. There is also a Word file ”input_tool_observations” that documents other known issues. You need Microsoft.NET framework, version 2 or higher (most current is 3.5) for the Input Tool to work.

Agenda for February 1, 2010 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Work on How To Document (User Guide) for In Put Tool.