CDISC-HL7 Stage II

Meeting Minutes

CDISC-HL7 Stage II December 10, 2008 12:30 pm – 1:30 pm (EST)

Attendees / Affiliation Jason Rock/Global Submit (Chair) Patty Garvey/FDA (Facilitator) Julie Evans/CDISC Terry Hardin/IBM Joyce Hernandez/Merck Mary Lenzen/Octagon Jay Levine/FDA Barrie Nelson/Amgen Armando Oliva/FDA Denise Plasenia/Medtronic Diabetes Mitra Rocca/Novartis Chris Tolk/CDISC Clyde Ulmer/NCTR Diane Wold/GSK

Background

FDA wishes to receive, in regulatory submissions, standard clinical study information content developed by the Clinical Data Interchange Standards Consortium (CDISC) in a Health Level 7 (HL7) message exchange format. This is key to the FDA strategic initiatives to improve public health and patient safety.

This project is currently broken into two stages: requirements analysis and message development. Stage IB team was developed and tasked with the requirements analysis responsibilities. Stage II team was developed and tasked with the message development responsibilities.

The purpose of the meeting is to review the September 2008 DSTU ballot comments for StudyParticipation and StudyDesign messages.

Discussion

 The November 5, 2008 meeting minutes were reviewed and approved.

 It was agreed that the regularly scheduled Stage II meeting on December 24 be rescheduled to December 17 at 11:00am to 1:00pm (EST). Page 2

 Patty recommended the group to review the Subject Data storyboards on HL7 wiki page. In previous discussion, Jason had indicated that the Patient Care Record standard may contain the Subject Data requirements, the group need to determine if this is the case.

 The group continued reviewing the September 2008 DSTU ballot comments for Study Participation and Study Design. Refer to the attachments. The discussion comments were captured in the “Disposition Comments” of the Ballot worksheet of the StudyParticipation and StudyDesign attachments. o For Study Participation – discussion were on comment #s 104-108, 110, 114, 120, and 142. o For Study Design – discussion were on comment #s 1, 6 and 7.

ACTION ITEMS: None

Attachments: (1) StudyParticipation Ballot Comments Worksheet (2) StudyDesign Ballot Comments Worksheet

ConsolidatedSP.xls ConsolidateSD.xls

Drafted: PGarvey/12-15-2008 Approved: 1-21-2009