HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-09-30

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HL7 Stability Standard Teleconference Minutes

September 30, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Art Griesser (Promethues), Sam Dana (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), and K. Beck (un-known)

  • Request the same day and time slot (every Monday 3:00pm to 4:00pm ET) for our teleconference.
  • Validator has been updated to check for the four new rules (1. If the Data File Type is “Cycled-Complex”, it must also submit the associated study XML file(s); 2. Check that all codes used in the message have a code system names, except for subjectProduct; 3. When the eStability code list exists, it must use the FDA preferred term in the exact case as shown in the code list. There are two code lists, NCI Thesaurus and FDA Substance Registration List; and 4. The file name (excluding the path name) has to be alphanumeric, lower case (Electronic Common Technical Document (eCTD) restriction), and hyphens (no underscores and no blank spaces). The file name, including the extension, cannot exceed 64 characters). Need to fix bug in rule 4 so path name passes.
  • Any type of sub study where sample is taken from a time point in a storage condition and placed at a different condition and tested would be “Cycled-Complex” and all the stability files (parent and sub) would be “Cycled-Complex” so they are associated.
  • Once all the pieces are in place the intention is that CVM would start accepting stability data in the HL7 XML eStability format or pdf in eSubmitter, which is voluntary at this time.
  • The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/7586/10999/HL7%20Drug%20Stability%20Reporting%20Validation%20Procedures_0_3_draft_9-17-13.zip) is the HL7 Drug Stability Reporting Validation Procedures_0.3_draftl_(9-17-13). Please look at and use track changes to edit and/or add comments.
  • The editor is available for download at https://module3solutions.com/ If you have downloaded it and got a "Failure sending mail" message. launch the application again. It will bring you back to License key request page. Take a screen shot of the page and email it to info@module3solutions.com. You will then be sent a key. Some SMTP servers are blocking the message.

Agenda for October 7, 2013 Teleconference:

  • We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
  • Discuss and approve edits to HL7 Drug Stability Reporting (eStability) Validation Procedures Document
  • Outstanding issues

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