Control/Query Meeting Minutes (Heading 1) s4

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

May 5, 2008

Monday Q1 – BRiDG Attendees First Name Last Name Affiliation E-mail Address Peter Haug Intermountain Health [email protected] Care Paul Avillach LESIM-ISPED [email protected] Theresa Brunone GSK [email protected] Robert Dunlop Infermed [email protected] Julie Evans CDISC [email protected] Joel Finkle Image Solutions, Inc. [email protected] Gabriele Fischer Pfizer [email protected] William Friggle Sanofi Aventis [email protected] Richard Furr SAFE Biopharma [email protected] University of California, Davera Gabriel Davis [email protected] Janet Gagnon Booz Allen Hamilton [email protected] Patricia Garvey FDA [email protected] Terry Hardin IBM [email protected] Smita Hastak Scenpro [email protected] Ed Helton CDISC / SAS [email protected] David Iberson-Hurst CDISC [email protected] Linda King Eli Lilly & Company [email protected] Rebecca Kush CDISC [email protected] Pierr-Yves Lastic Sanofi Aventis [email protected] Peggy Leizear FDA [email protected] David Loose BLC [email protected] Andrew Marr GSK [email protected] Barbara McKinnon McKinnon Associates [email protected] Meredith Nahm Duke [email protected] Armando Oliva FDA [email protected] Cecile Pistre Sanofi Aventis [email protected] Mitra Rocca Novartis [email protected] Jason Rock Global Submit [email protected] Karen Ryan Booz Allen Hamilton [email protected] Steve Sandberg Mayo [email protected] Kris Spahr Wyeth Pharmaceuticals [email protected] John Speakman NCI [email protected] Sadamu Takasaka HL7 Japan [email protected] Ed Tripp Abbott Laboratories [email protected] Marti Velezis Booz Allen Hamilton [email protected] Wendy Ver Hoef Scenpro [email protected] Anita Walden Duke [email protected] Steve Ward Lilly [email protected] I. BRIDG Update and Education – Julie Evans Julie presented the attached material

"BRIDG Update May 2008 WGM.ppt" The BRIDG Advisory board has been renamed BRIDG Board of Directors. A new charter was developed including by-laws. Release 2.0 is scheduled for May 2008. R2.0 contains new content for AE and NCI Patient Registry and full binding to HL7 V3 data types and persons/organization (player/scope). There are plans to resolve several model inconsistencies. The BRIDG Board of Directors has decided that there will be 1-2 releases per year. RCRIM Project managers should communicate the need for BRIDG modeling and harmonization activities through the BRIDG Board of Directors or the THC. Education on Release 2 will be scheduled for the September Working Group Meeting.

II. Research classification - CTSA project interface with BRIDG - Meredith Nahm and Davera Gabriel Meredith presented the attached slides

2008-0503-CTSA-HS MR.ppt There is an upcoming BRIDG CTR modeling sessions and CTSA is invited to attend the session. It was suggested that a BRIDG educational session with a focus on CTR would be useful for the CTSA members. CTSA should work with Julie Evans to schedule.

Monday Q2 – RPS First Name Last Name Affiliation E-mail Address Pharmaceuticals & Yasuhiro Araki Medical Devices [email protected] Lori Baranoski BMS [email protected] Bob Birmingham J&J [email protected] Theresa Brunone GSK [email protected] Tim Buxton EMEA [email protected] Robert Dunlop Infermed [email protected] Pharmaceuticals & Daigoro Ebina Medical Devices [email protected] Julie Evans CDISC [email protected] Joel Finkle Image Solutions, Inc. [email protected] First Name Last Name Affiliation E-mail Address Gabriele Fischer Pfizer [email protected] William Friggle Sanofi Aventis [email protected] Richard Furr SAFE Biopharma [email protected] Janet Gagnon Booz Allen Hamilton [email protected] Patricia Garvey FDA [email protected] Scott Getzin Eli Lilly and Company [email protected] Terry Hardin IBM [email protected] Ed Helton CDISC / SAS [email protected] David Iberson-Hurst CDISC [email protected] Rebecca Kush CDISC [email protected] Pierr-Yves Lastic Sanofi Aventis [email protected] Peggy Leizear FDA [email protected] Randy Levin FDA [email protected] David Loose BLC [email protected] Andrew Marr GSK [email protected] Barbara McKinnon McKinnon Associates [email protected] Meredith Nahm Duke [email protected] Armando Oliva FDA [email protected] Cecile Pistre Sanofi Aventis [email protected] Bill Rosen Pfizer [email protected] Karen Ryan Booz Allen Hamilton [email protected] Steve Sandberg Mayo [email protected] Mary Ann Slack FDA [email protected] Kris Spahr Wyeth Pharmaceuticals [email protected] Sadamu Takasaka HL7 Japan [email protected] Ed Tripp Abbott Laboratories [email protected] Marti Velezis Booz Allen Hamilton [email protected] Steve Ward Lilly [email protected] Taku Watanbe PMDA [email protected]

I. RPS R1 Implementation Guide Ballot Reconciliation – Jason Rock Ballot results are summarized below: Affirmative Negative Abstain No Vote Affiliate 1 0 7 1 Consultant 2 0 2 0 General Int. 18 0 0 1 Payor 0 0 0 0 Pharmaceutical 12 3 2 13 Provider 13 0 14 0 Vendor 6 1 5 1 Totals 52 4 30 16 % of Votes 50.98% 3.92% 29.41% 15.69% Quorum 84.31% Approval 34 Kris Spahr expressed a concern over the format of the document. Kris will review the revised document to determine if the format issues have been addressed. Ed Tripp expressed concern that specific media types were specified in the document. Motioned made by Ed Tripp to remove the reference to specific media. Joel Finkel seconded the motion. There was no discussion. Vote: Affirmative: 20 Negative 0 Abstain 15 Paragraph was removed. Sarah Powell objected to the use of ellipses in the XML code. Terry Hardin made a motion that ellipses in the XML code be replaced with “…other non-relevant XML code…”. Motion was seconded by Bob Birmingham. Vote: Affirmative: 23 Negative 0 Abstain 13 The substitution will be made in the document. Sarah Powel objected to section 2.3 Nesting Level and the specification of folders and subfolders. Motion by Jason Rock and seconded by Bob Birmingham to replace the paragraphs within the section with “To be determined when more specific guidance is provided by receiving agency.” Vote: Affirmative: 20 Negative 0 Abstain 15 Section was revised. There are no substantive changes to the document and the document will be published with the revisions.

II. RPS R2 - Mary Ann Slack Mary Ann presented the following:

RPS_Overview_2008 -05-04-MA(2).ppt

III. Review / discuss requirements gathering process: - Janet Gagnon and Karen Ryan Janet presented the following:

"WG Meeting 5 May 05 Final v3.0.ppt" Monday Q3 –RPS R2 Attendees First Name Last Name Affiliation E-mail Address Pharmaceuticals & Yasuhiro Araki Medical Devices [email protected] Lori Baranoski BMS [email protected] Bob Birmingham J&J [email protected] Tim Buxton EMEA [email protected] Pharmaceuticals & Daigoro Ebina Medical Devices [email protected] Joel Finkle Image Solutions, Inc. [email protected] Myron Finseth Medtronic [email protected] Gabriele Fischer Pfizer [email protected] William Friggle Sanofi Aventis [email protected] Richard Furr SAFE Biopharma [email protected] Janet Gagnon Booz Allen Hamilton [email protected] Patricia Garvey FDA [email protected] Scott Getzin Eli Lilly and Company [email protected] Terry Hardin IBM [email protected] Ed Helton CDISC / SAS [email protected] Joyce Hernandez Merck [email protected] David Iberson-Hurst CDISC [email protected] Pierr-Yves Lastic Sanofi Aventis [email protected] Peggy Leizear FDA [email protected] Andrew Marr GSK [email protected] Armando Oliva FDA [email protected] Cecile Pistre Sanofi Aventis [email protected] Bill Rosen Pfizer [email protected] Karen Ryan Booz Allen Hamilton [email protected] Mary Ann Slack FDA [email protected] Kris Spahr Wyeth Pharmaceuticals [email protected] Sadamu Takasaka HL7 Japan [email protected] Ed Tripp Abbott Laboratories [email protected] Marti Velezis Booz Allen Hamilton [email protected] Steve Ward Lilly [email protected] Taku Watanbe PMDA [email protected] Diane Wold GSK [email protected]

IV. Discuss key stakeholder representation for requirements gathering process: - Janet Gagnon Janet led the group through a number of items: a) Prior History

b) Scope

c) SME’s d) Agreement

e) Develop Strawman

f) Engaging Community  Invitation  Communication  Goals and objectives  RPS 1 history  Communicate the “what”  Validate the strawman and refine Kris Spahr suggested that RCRIM explores in teleconference and perhaps the next WGM if BRIDG should continue to encompass both clinical research, or should we have separate Domain Analysis Models.

V. Next steps, including June face-to-face meeting: Need to define meeting: g) Purpose, Goals and Objectives Working sessions to obtain understanding and agreement to respond to a straw man. h) Logistics i) Announcements j) Invitations Discussion will continue in Q4

Monday Q4 Digital Identity and Signature Standard Attendees First Name Last Name Affiliation E-mail Address Pharmaceuticals & Yasuhiro Araki Medical Devices [email protected] Kay Avant University of Texas [email protected] Health Science Cntr Bob Birmingham J&J [email protected] Christopher Chute Mayo Clinic/Foundation [email protected] Pharmaceuticals & Daigoro Ebina Medical Devices [email protected] Julie Evans CDISC [email protected] Joel Finkle Image Solutions, Inc. [email protected] Myron Finseth Medtronic [email protected] Gabriele Fischer Pfizer [email protected] William Friggle Sanofi Aventis [email protected] Richard Furr SAFE Biopharma [email protected] University of California, Davera Gabriel Davis [email protected] Scott Getzin Eli Lilly and Company [email protected] Terry Hardin IBM [email protected] First Name Last Name Affiliation E-mail Address Ed Helton CDISC / SAS [email protected] Joyce Hernandez Merck [email protected] David Iberson-Hurst CDISC [email protected] Linda King Eli Lilly & Company [email protected] Rebecca Kush CDISC [email protected] Pierr-Yves Lastic Sanofi Aventis [email protected] Peggy Leizear FDA [email protected] David Loose BLC [email protected] Meredith Nahm Duke [email protected] Armando Oliva FDA [email protected] Cecile Pistre Sanofi Aventis [email protected] Steve Sandberg Mayo [email protected] Kris Spahr Wyeth Pharmaceuticals [email protected] John Speakman NCI [email protected] Sadamu Takasaka HL7 Japan [email protected] James Tosone Pfizer [email protected] Ed Tripp Abbott Laboratories [email protected] Marti Velezis Booz Allen Hamilton [email protected] Steve Ward Lilly [email protected] Taku Watanbe PMDA [email protected] Diane Wold GSK [email protected]

I. Digital Identity and Signature Standard – Rich Furr Rich presented material describing the SAFE digital signature standardized process. Rich inquired if there was a joint project for RCRIM that could include SAFE. It was suggested that discussion with CDA would be a good starting point since CDA has a signature concept built in.

II. Personal Health Record (PHR) Profile for Clinical Research - Jim Tosone Jim presented the following:

"HL7 PHR Profile for Clinical Research.ppt" It was suggested that this be revisited Q2 Wednesday following the EHR CR Profile reconciliation

III. RPS Next Steps Continued – Janet Gagnon For the meeting on the 17th of June, the intent would be to set up the conference call for RPS R2 and invite those participants to the face to face meeting. Activities for the kick-off meeting:  Boiler plate the scope  Develop a communication plan to communicate to the working Group  Develop a communication plan to communicate to the Domain/SME’s  By the 17th communicate the timeline and development plan.  Roles and responsibilities are agreed upon.  Establish a “RPS for dummies” slide set SME and Domain Expert needs for the project are a deliverable from the meeting. End of Document