Minutes QRPH Aug 7 2008 DSC Profile

Minutes QRPH Drug Safety Content Profile Tcon July 31, 2008

Attendees

• Floyd Eisenberg, Siemens Healthcare (Co-chair)
• Jason Colquitt, Greenway Medical Systems (Co-Chair)
• Ana Estelrich, DIP, GMP (Planning Committee Co-Chair)
• Gary Walker, CDISC / Quintiles

Drug Safety Content

The Drug Safety Content Profile was reviewed in detail and has been updated. Changes were made using track changes function in Word.

Use the following link for the update (August 7, 2008)

• Aug 7, 2008 Working Version
• AHIC Data Set for CCD and E2B M Mapping

Next Steps

• CCD Mapping of data elements - Floyd Eisenberg and Jason Colquitt complete, some elements added to table based on PCC Immunization Content Document efforts
• E2B M Mapping of data elements for test / reference implementation - Michael Ibara, Completion Expected Aug 18
• Submit updates to Floyd Eisenberg (Floyd.Eisenberg@siemens.com) for incorporation into new version of the profile
• No further Tcon has been established. Continued work will be completed (update to CCD mapping table and reference implementation) through August 18 at which time the document is expected to be sent for public comment.