HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-07-11

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

July 11, 2011

Attendees: Norman Gregory (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sunovion), Mike Yang (ScienTek Software), and Howard Shatz (Data Conversion Laboratory, Inc.)

• SPL uses the OID 2.16.840.1.113883.3.26.1.1 to identify the code system for Dosage Form (2.16.840.1.113883.3.26.1.1.2) , Route of Administration (2.16.840.1.113883.3.26.1.1.1), Package Type (2.16.840.1.113883.3.26.1.1.3) and the code system name is not captured in the XML. The OID 2.16.840.1.113883.3.26.1.1 would have the code system name "National Cancer Institute Thesaurus" if the codeSystemName was displayed. If we wanted the XML to display the code system name as the right stability terminology group we would need to use that OID (e.g., 2.16.840.1.113883.3.26.1.1.X). After conversations with Terry Quinn (NCI-EVS) and to match what SPL does we will use the OID 2.16.840.1.113883.3.26.1.1 and not have the code system name. This would be the quickest and easiest way to deal with the issue. We can still discuss the issue if there is a need.
• The link to the FDA Drug Nomenclature Monographs web site (where the OIDs for dosage form, package type, ect. can be found) is http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm071650.htm
• The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6373/8529/eStability_Implementationguide_1_8_draft_7-11-11.zip) is the new version of the IG (1.8 draft (7-11-11)) with the changes (so far) based on the May 2011 HL7 ballot and codes, save file and change extension from .piz to .zip.

Agenda for July 18, 2011 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
• Changes to IG
• Schematron progress update
• Outstanding issues