HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-12-07

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

December 7, 2009

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Diane Miller (Alpharma)

• Input Tool is free, source code is closed owned by Company.
• Terry need feedback, only feedback he has received is adding tool tips.
• Input Tool feedback from this teleconference and e-mails received:

1. Add radio button to message tab for "FDA" message vs. HL7 message.

2. Use color blue for mandatory fields based on which validation radio button is selected on message tab.

3. Tool Tips - text will indicate if field is required for HL7 or mandatory for FDA.

4. All tabs - Remove button does not warn user. Always just remove regardless.

5. Study Root tab:

a. Associated Studies - Need rework to accommodate new <text> tag which stores the XML filename of associated study

b. Study Code - when the loaded XML file is a "Cycled Study, The Cycled Study option button is not selected.

6. Organizations tab - Need State box when inputting address.

7. Product/Substance tab:

a. Expiration Time - does not show the Expiration Time in XML file. Always show 2001-01-01

b. Specified Ingredient - Does not show Denominator unit, when present in XML file.

c. Type frame - Always selects Finished Product option button even when the XML file is for API.

8. Test Specification tab - Assigned manufacturer does not show info when present in XML file.

9. Study Info tab;

a. Container Capacity - does not show info when present in XML file.

b. Container Quantity - Does not show Denominator unit, when present in XML file.

10. Have dropdown for “approved”, “proposed”, and “mot established”.

• Review expiration date requirements with Common Product Model team at January HL7 meeting.
• Started looking at the User Guide for the Input Tool: http://gforge.hl7.org/gf/download/docmanfileversion/5384/6740/eStabilityInputToolUserGuidev0.2.doc
• 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 SMIT0942.zip and the expiration is 1/1/2010. 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.
• Looking to change the teleconference time to Mondays from 2:00pm to 3:00pm, need to check with HL7 on the availability of that time. Will not change until after January HL7 meeting week of 1/18-22/2010.

Agenda for December 14, 2009 Teleconference:

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