control query meeting minutes( heading1)（控制查询会议纪要(heading1)）.docVIP

Regulated Clinical Research Information Management (RCRIM) Technical Committee Meeting Minutes September 17, 2008 Wednesday Q1 – BRIDG, Protocol and Clinical Registration Attendees First Name Last Name Affiliation E-mail Address Lisa Chatterjee Digital Infuzion lisac@ Sue Dubman Genzyme sue.dubman@ Kristi Eckerson Emory University keckers@ Julie Evans CDISC jevans@ Davera Gabriel University of California, Davis davera@ Smita Hastak Scenpro shastak@ Ed Helton NCI edward.helton@ Joyce Hernandez Merck joyce.hernandez@ David Iberson-Hurst CDISC dibersonhurst@ Raffael Jovine Int.Inst. For SAEE of Meds. raffael.jovine@ Bron Kisler CDISC bkisler@ Wayne Kubick Lincoln Technologies (CDISC) wayne.kubick@ Pierre-Yves Lastic Sanofi Aventis pierre-yves.lastic@ Mary Lenzen Octagon mlenzen@ Charlie Mead NCI charlie.mead@ Tim Morris Emory University timothy.morris@ Barrie Nelson Amgen barrien@ Armando Oliva FDA armando.oliva@ Cecile Pistre Sanofi Aventis cecile.pistre@ Mitra Rocca Novartis mitra.rocca@ Steve Sandberg Mayo Clinic/Foundation ssandberg@ Benjamin Schoenbrun Booze Allen Hamilton schoenbrun.benjamin@ Kris Spahr Wyeth Pharmaceuticals spahrk@ John Speakman NCI john.speakman@ Anita Walden Duke anita.walden@ Steve Ward Lilly stw@ Diane Wold GSK diane.e.wold@ Protocol Representation Standards V 1.0 - Lisa Chatterjee Lisa gave background and update – CDISC elements spreadsheet was original basis of BRIDG. PR and the other CDISC standards will continue to exist independent of BRIDG Q: RCRIM has voted to use BRIDG as the DAM. How do we implement this? A: Through using it in message ballots – reviewing the appropriate portions of BRIDG in each message. Q: Should we ballot on BRIDG as an informative document? A: There is an ideal time for this: discuss after Charlie’s presentation. Status of Domain Model (BRIDG Update and issues) - Julie Evans, Charlie Mead BRIDG update – Julie Evans BRIDG lessons learned and next steps – Charlie Mead Nex