HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-05-11
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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
May 11, 2009
Attendees: Norman Gregory (CVM), Terry Hardin (Perfitech), Elizabeth Cormier (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), Holly Settles (Elanco), and Maje Nazim (Genzyme)
- Jason has started on XForm, he is Japan at HL7 Meeting this week.
- Terry hopes to have some screen shots available for next Mondays (5/18) teleconference. We would like do a WebNR or some other form of document share. I can set up a meeting using Adobe connect for the document share and we can do audio with the teleconference number. I will send out the link for the Adobe connect with the reminder on Thursday.
- I will add the call in number information to the reminder.
- The units in the child elements were removed, resizes popups to take up less space, and put OOS in parenthesis after the value.
- The style sheet has the heading "Expiration Dating:" If the stability data is for a product the heading will be "Expiration Dating:", if it is for a substance the heading will be "Retest Date:".
- From the XML if a zero value is provided for ExpirationTime (e.g., P0M) for Product this indicates the expiration date has not been determined yet (page 24 of IG) and the ExpirationTime for ManufacturedMaterial (page 36 IG) is an interval value (e.g., P24M) than this is a proposed expiration data and under the heading "Expiration Dating:" will display "24 months (proposed)".
- From the XML if a value is provided for ExpirationTime (e.g., P24M) for Product this indicates the expiration date has been determined and approved (page 24 of IG) and the ExpirationTime for ManufacturedMaterial (page 36 IG) is a date value (e.g., May 2011) than this is an approved expiration data and under the heading "Expiration Dating:" will display "24 months (approved)".
- There could be an issue with Substance (page 26 IG) because the is no expirationTime attribute. This means that the retest date would have to come from the expirationTime for ManufacturedMaterial and if it is an approved retest date, a date value was provided so the interval value would need to be calculated from the ExistanceTime (page 36 IG).
- The implementation Guide is available Implementation Guide.
- The "Study Purpose" needs clear information explaining what this study is about and what the labeled storage condition is.
Agenda for May 18, 2009 Teleconference:
- Discuss the style sheet example.
- XForm and input tools update.
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