Minutes Drug Safety Content Profile July 3, 2008

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Agenda (Minutes) Drug Safety Content Profile July 3, 2008

Attendees

  • Floyd Eisenberg, (Siemens Healthcare) Co-Chair
  • Shawn Dunaway-Shanks, (Siemens Healthcare)
  • John Donnelly, (IntePro Solutions) Co-chair, PCC Planning
  • Ana Estelrich, (GIP-DMP) Co-Chair, QRPH Planning
  • Rhonda Facile, (CDISC)
  • Lori Fourquet, (eHealth Sign)
  • Peter Hesse, (Gemini Security Solutions)
  • Walt Turnes, (Gemini Security Solutions)
  • Gary Walker, (Quintiles)
  • Daemon Whittenburg, (Greenway Medical Systems)
  • Lisa Spellman, (HIMSS)

Drug Safety Content

Prior Discussions for Reference:

Discussion

  • Review current draft of White Paper - consolidated from existing Drug Safety Content Profile draft and content from minutes of prior discussions.
  • Rhonda Facile (CDISC) noted CDASH completed a public comment period June 30, 2008 with approximately 1850 comments. Resolution of comments for publication of version 1.0 is anticipated in 3rd quarter, possibly around September, 2008. Some of the CDASH review of elements within the existing version of the white paper can be reviewed in concert with the comment resolution. More information will be available after an interchange meeting for CDASH next week.
  • Peter Hesse and Walt Turnes are working on a component for the Clinical Research Data Capture Profile to assure signatures can be in compliance with the Safe Biopharm requirements. The same security concerns will enhance the white paper. Discussion of the issue will occur during the comment resolution for Clinical Research Data Capture. For domain expert attendance, coordination of the Clinical Research Data Capture comment resolution on Wednesday (July 23) during the face-to-face meeting with the Drug Safety White Paper (July 24-25) is preferred.

Updates to the existing outline for the white paper

  • Add workflow for the form for each of the Use Cases (only one Use Case currently has content to date)
  • Support for Queries for Multiple Patients will be required, similar to requirements for Lab and for Quality use cases. A new supplement to ITI may be required
  • Support for pseudonymization is required, which will also require a profile for ITI
  • A section for security will need to be added to the white paper. See the last bullet under "discussion" for a component of the security issue, similar to that required for Clinical Research Data Capture.

Next Steps

Return to: Quality, Research and Public Health Technical Committee