HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-04-13
Return to Drug Stability Reporting
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
April 13, 2009
Norman Gregory (CVM), Terry Hardin (Perfitech), Mai Huynh (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Lisa Ylitalo (Eleos), and Mike Yang (ScienTek Software)
- Scheduled to give presentation to FDA Premarket BRB on April 20th concerning style sheet and viewer development.
- Terry should have something regarding the in-put tool by Monday (4/20). It appears that Jason (Global Submit) is still on track for the XForm at the end of April.
- Hover over a value with replicates, in parenthesis, get a table of all the values, minimum, maximum, RSD and average.
- For Pass/Fail results with replicates, if all pass or all fail would display pass (#) or fail (#) respectively, if results are mixed would display P/F (#).
- Need feed back on color scheme.
- Out of spec result would be bold, if one of the replicates is out of spec the number in the parenthesis would be bold.
- The flat file will be for viewing all values and to manipulate them.
- We need someone in the WG with a Mac to test the style sheet, so please if you own a Mac try it out.
- Will Try to get Mead to be on the call April 20th regarding more attributes with AssociatedStudy( e.g, Text: ED).
- Correction to last week, the reason files can not begin with the number 1 is because they are OIDs. Under ISO 8824, OID numbers are assigned according to a hierarchical structure and 1 is for International Standards Authority. If we can have a reference on AssociaterdStudy the file name could be something else.
Agenda for April 20, 2009 Teleconference:
- Talk with Mead Walker?
- Discuss the style sheet example.
- XForm and input tools update.