HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-01-31

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

January 31, 2011

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), Diane Miller(Alpharma), and Art Griesser (Promethues)

• I am getting an Outlook Mailbox set up with the name eStability@fda.hhs.gov to point to from our different document when needed. The three people with access will be Norman Gregory, Elizabeth Cormier, and David Longstaff.
• I checked with Scott Fontana (CVM eSubmitter contact) about the time frame for submitting stability in the HL7 xml file format for eSubmitter and what was said at the November Animal Health Institute (AHI) meeting and this is what was said: "CVM is going to require stability data in the HL7 XML format, eventually. (estimate 12 -18 months from now). In the interim, we will accept stability data in a PDF format. At release we will accept XML stability data; however, if the data comes in as an XML file it MUST conform to the HL7 standard. The HL7 Standard is established and posted on FDA.gov, under the Data Standards page as well as CVM eSubmitter page." I changed the new web page we want to get posted with the following: "Drug Stability Reporting (eStability) is an Health Level Seven (HL7) standard to facilitate the processing and review of stability data. The standard has been adopted by FDA as a mechanism for reporting stability data. It will be accepted by CVM starting in January 2011 and will be required in March 2011 January 2012 for any submissions through the Food and Drug Administration's eSubmitter to CVM, in the interim stability data in PDF format will be accepted by eSubmitter. CDER will strongly recommend submitting stability data using the Stability Data Standard in Q3 of 2011". The italic is deleted and the bold is added.
• There were some questions about some of the rules in the validation document, no spaces in codes and no spaces in id extensions, ect. Spaces in code will fail schema and we need to test the other rules in the document.
• The HL7 schema files should have the version number, when the corrections are made at HL7 will need to change the core schemas we reference.
• I sent an e-mail to the RCRIM Co-Chair asking about "When will the Normative edition from the May 2010 WG be published?" and "Are the questions eStabillity had regarding changes made to core schemas that effect other messages (e.g., eStability) on the TSC agenda yet?". He will get back to me, they are not true agenda items for RCRIM.
• I sent an e-mail to Bill Hess, FDA liaison with NCI, about our code lists, I have attached (http://gforge.hl7.org/gf/download/docmanfileversion/6127/8001/CodeLists.doc) the Code lists (I did make some edits to it). I sent the following: "Attached is the code list for Drug Stability Reporting (eStability). Most of the codes are from SPL, the closure list is from the Closure Manufactures of America (CMA), and the rest are from the eStability Working Group. For Test Code and Method Type Code I added "Stability Study" as you suggested. We would like all these codes held and managed by NCI. The code for "other" can be deleted when ever it appears and we will direct people to register any new code value with NCI like SPL does."
• The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6126/8000/HL7DrugStabilityReportingValidationProcedures1-31-11.doc) is the validation document (HL7 Drug Stability Reporting Validation Procedures (1-31-11).doc) which has Mike Yang's edits that we started going through, we got to Section 1.1.4.

Agenda for February 7, 2011 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Schematron progress update
• eStability Validation Procedures document.