Minutes QRPH July 31 2008 DSC Profile Call

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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)
  • Lise Stevens, FDA
  • 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 (July 31, 2008)

Next Steps

  • CCD Mapping of data elements - Jason Colquitt to begin, some elements added to table based on PCC Immunization Content Document efforts
  • E2B M Mapping of data elements for test / reference implementation - Michael Ibara
  • Submit updates to Floyd Eisenberg (Floyd.Eisenberg@siemens.com) for incorporation into new version of the profile
  • Tcon Thursday, August 7 1:00 - 3:00 PM CDT for final review and acceptance to go to public comment