HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-06-11
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
June 11, 2012
Attendees: Norman Gregory (CVM), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), and Howard Shatz (Data Conversion Laboratory, Inc.)
- Josh is still working on a new version of the validator with enhancements.
- Evidently there are some parts of the SPL schamatron which are proprietary. Who owns the SPL schematron? When was the original SPL schematron written (2005, 2006,...)? Pragmatic Validator Lite SPL Vlaidation Tool -V1.7 copyright 2008-2011.
- Catherine did a demonstration of the VB.NET In-Put Tool.
- VB.NET Form: Looking into a pick-list to select screen resolution.
- VB.NET Form: Asterisk (*) indicates required fields. For Establishment tab (all facilities are entered here StudySponser, Manufacturer, and TestingSite) the IG does not state the rules for address, but the examples are correct and follow the rules from the document "HL7 Drug Stability Reporting (eStability) Validation Procedures" Section 3.7.3, 3.21.3, and 3/29/3 (see minutes from 12/12/11 for document). We did not specify using the ISO 3 letter system in the document. From document:
1. An address has a street address line, city, and country.
2. Country is composed of letters only.
3. If the country is “USA”, then the contact party has a state and postal code.
4. If the country is “USA”, then the postal code is 5 digits with optionally a dash followed by 4 numbers.
5. If the country is not in the postal code validation list, then there must be a postal code. The postal code list is in the downloadable terminology files "Additional Validation Files" and the file name is “postal_codes_val.xml” located on this web page:http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm,. We utilize this list to determine whether or not a country has a postal code system when validating drug establishment registration submissions.
From SPL IG/VP:
For addresses (addr) the following rules apply
<addr> <streetAddressLine>1625 29th street </streetAddresslLine> <city>Camden</city> <state>NJ</state> <postalCode>08101</postalCode> <country code=”USA codeSystem=”1.0.3126.96.36.199”>USA</country> </addr>
1. An address has street address line, city, and country
2. If there is a country code, then it is an ISO 3-letter country code (code system "1.0.3188.8.131.52").
3. If there is no code attribute, then the country name may be the code, otherwise country is a full country name matching the code.
4. If the country is "USA", then the contact party has a state (2 letters) and postal code
5. If the country is "USA", then the postal code is 5 digits with optionally a dash followed by 4 numbers
6. If the country is not in the postal code validation list, then there is a postal code.
- VB.NET Form: All grids have dynamic columns (can be sized).
- VB.NET Form: The 2x Results tab will have a different color scheme from the Results tab to distinguish between the two to avoid confusion with witch tab you are in.
- VB.NET Form: Load CSV file, if there is a specification that has a level hierarchy order (parent-child, 1st level-2nd level), the parent and child CSV files would be loaded separately.
- There will be no teleconference on June 18th, June 25th, and July 2, 2012.
Agenda for July 9, 2012 Teleconference:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
- VB.NET Forms
- Outstanding issues