Regulated Clinical Research Information Management (RCRIM) Technical Committee Meeting Minutes

January 14, 2007

Monday Q3 Attendees First Name Last Name Affiliation E-mail Address Paolo Alcim EMEA [email protected] Bob Birmingham J&J [email protected] Tim Buxton EMEA [email protected] Diagoro Ebina PMDA [email protected] Floyd Eisenberg Siemens Healthcare [email protected] Julie Evans CDISC [email protected] William Friggle Sanofi Aventis [email protected] Richard Furr SAFE Biopharma [email protected] Janet Gagnon Booz Allen Hamilton [email protected] Scott Getzin Eli Lilly and Company [email protected] Norman Gregory FDA [email protected] Terry Hardin IBM [email protected] Smita Hastak Scenpro [email protected] Ed Helton CDISC / SAS [email protected] Joyce Hernandez Merck [email protected] Masaaki Hirai HL7 Japan [email protected] Julie Hurley RWD [email protected] David Iberson-Hurst CDISC [email protected] Don Kacher Oracle [email protected] Bron Kisler CDISC [email protected] Gurnar Klein KI [email protected] Rebecca Kush CDISC [email protected] Pierr-Yves Lastic Sanofi Aventis [email protected] Randy Levin FDA [email protected] Doug Luczak Abbott Laboratories [email protected] Andrew Marr GSK [email protected] Saurin Mehta Novartis [email protected] Linda Mook NICTIZ [email protected] Jennifer Neat City of Hope [email protected] Armando Oliva FDA [email protected] Cecile Pistre Sanofi Aventis [email protected] Phil Pochon Covance [email protected] Jason Rock Global Submit [email protected] Bill Rosen Pfizer [email protected] Steve Sandberg Mayo [email protected] Mary Ann Slack FDA [email protected] Betsy Smith FDA [email protected] Kris Spahr Wyeth Pharmaceuticals [email protected] John Speakman NCI [email protected] Sadamu Takasaka HL7 Japan [email protected] First Name Last Name Affiliation E-mail Address Jennifer Teta Merck [email protected] Sylvia Thun DIMDI [email protected] Ed Tripp Abbott Laboratories [email protected] Marti Velezis Booz Allen Hamilton [email protected] Taka Watanbe PMDA [email protected]

I. Co Chair elections It was proposed that the number of co-chairs was expanded to four. One of the co-chair terms will be one year to move to a ballot cycle that will have two co-chairs elected each January. John Quinn indicates that it would be acceptable to expand the number of co-chairs from 3 to 4 without 30 days prior notification of anyone balloting because there are three candidates that declared they were running so all will be elected. A show of hand indicated that the majority of the members present could support expanding from 3 to 4 co-chairs. John Speakman, Ed Tripp and Randy Levin were elected with Randy serving the one-year term Rich Furr made a motion to expand the number of co-chairs to five with the fifth co-chair being a non-US HL7 member and that the election would be held in September. Bob Birmingham seconded the motion and discussion followed. A vote was taken. Vote: For 6 Against 8 Abstain 21 Motion did not carry.

II. Accepting minutes The minutes from the September WGM have been posted. A motion was made and seconded to accept the minutes. The motion was carried by voice vote. III. Teleconference Decisions a) Monday 10:00-11:00 Stability meeting to remain as is. 11:00 – 1:00 Clinical Research Filtered Query Service (CRFQS) biweekly –to be rescheduled b) Tuesday 10:00-11:00 RCRIM conference call every other week. 11:00-12:30 RPS every other week should not be rescheduled. c) Wednesday 10:00 – 11:00 Lab Result-based Adverse Event Assessment Project d) Thursday 11:00-12:30 Vocabulary every other Thursday. e) Friday 10:00-11:00 eDCI weekly 10:00-12:00 Pharmacogenomics (every other week)

IV. Project Status Document – Kris Spahr Kris presented the attached as a proposed project status to be filled out and distributed by each project lead monthly

"RCRIM Project Status Template V1.doc" Kris will review the current PMO document and compare it to the content of this status document and present the findings back at the next RCRIM teleconference.

Monday Q4 – RPS Discussion and CDISC content to message. First Name Last Name Affiliation E-mail Address Paolo Alcim EMEA [email protected] Bob Birmingham J&J [email protected] Diagoro Ebina PMDA [email protected] Floyd Eisenberg Siemens Healthcare [email protected] Julie Evans CDISC [email protected] William Friggle Sanofi Aventis [email protected] Janet Gagnon Booz Allen Hamilton [email protected] Scott Getzin Eli Lilly and Company [email protected] Terry Hardin IBM [email protected] Smita Hastak Scenpro [email protected] Ed Helton CDISC / SAS [email protected] Joyce Hernandez Merck [email protected] Masaaki Hirai HL7 Japan [email protected] Julie Hurley RWD [email protected] David Iberson-Hurst CDISC [email protected] First Name Last Name Affiliation E-mail Address Don Kacher Oracle [email protected] Bron Kisler CDISC [email protected] Gurnar Klein KI [email protected] Rebecca Kush CDISC [email protected] Pierr-Yves Lastic Sanofi Aventis [email protected] Randy Levin FDA [email protected] Doug Luczak Abbott Laboratories [email protected] Andrew Marr GSK [email protected] Saurin Mehta Novartis [email protected] Jennifer Neat City of Hope [email protected] Armando Oliva FDA [email protected] Phil Pochon Covance [email protected] Jason Rock Global Submit [email protected] Bill Rosen Pfizer [email protected] Steve Sandberg Mayo [email protected] Mary Ann Slack FDA [email protected] Betsy Smith FDA [email protected] Kris Spahr Wyeth Pharmaceuticals [email protected] John Speakman NCI [email protected] Sadamu Takasaka HL7 Japan [email protected] Jennifer Teta Merck [email protected] Sylvia Thun DIMDI [email protected] Ed Tripp Abbott Laboratories [email protected] Marti Velezis Booz Allen Hamilton [email protected] Taka Watanbe PMDA [email protected] I. Agenda change The BRIDG session will be moved to Q2 Tuesday and the EHR session will be held on Q1 Wednesday.

II. RPS FDA has a need for RPS 2 for PDUFA IV goals. PMDA is very happy to join the discussion of RPS 2. PhRMA has tentatively earmarked funding to be used for a HL7 project manager. ICH committed that they would start gathering requirements for the next version of eCTD.

III. CDISC Content To Message Exploratory Project Armando Oliva and David Iberson-Hurst and Jason Rock presented the following slides.

"20080114 HL7 CDISC-HL7 Project Update.ppt"

"CDISC Content to Message - Message Development.ppt" End of Document