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

September 28, 2010 Attendees First Name Last Name Affiliation E-mail Address Joel Finkle Image Solutions, Inc. [email protected] Myron Finseth Medtronic [email protected] Patricia Garvey FDA [email protected] Scott Getzin Eli Lilly and Company [email protected] Norman Gregory FDA [email protected] Jason Rock Global Submit [email protected] Steve Sandberg ScenPro [email protected] Abdul Malik Shakir Shakir Consulting [email protected] Salimah Shakir Shakir Consulting [email protected] Ed Tripp Edward S. Tripp and [email protected] Associates Steve Ward Lilly [email protected]

I. Approval of RPSr2 Ballot Reconciliation

V3_RP_R2_D1_2010 JAN-CONSOLIDATED.xls

The reconciliation package was presented. There was a question about the resolution of the cardinality issue. Jason gave an overview of the resolution and stated he would provide an e-mail identifying where in the reconciliation package that information could be found. A motion was made by Jason Rock and seconded by Norman Gregory to approve the ballot reconciliation pending receipt of the information on the resolution of the cardinality issue. Affirmative: 10 Negative: 0 Abstain: 0 Motion carries Ed Tripp will post the reconciliation package following receipt of the information on cardinality. II. RASH Update on Vocabulary, Structured Documents and Implementation/Conformance (Joel Finkle) Joel has not had a chance to go to Structured Documents. Consensus from RPS is that we are not ready for this and we should concentrate on RPSr3 requirements.

III. Decision Making Practices (DMP)

Generic_HL7_WG_D MP_v3.0_Template.doc

1 New Template

RCRIM_Decision_Ma king_Practices_v2.0.doc

2 Current RCRIM Document

HL7 New Template Decision Making Practices comparison_9-10-10.doc

3 Comparison of template to RCRIM DMP Latousha Leslie provided the comparison document, but was not available on this call. The comparison looks at what is new in the template as compared to our current DMP. A review of what is in our current DMP that is absent from the template still needs to be conducted. Ed Helton will work with Latousha and this will be placed on the Cambridge business meeting agenda.

IV. Preparing for the Sydney WGM The following communication was received from the TSC. Planning for the January 2011 Working Group Meeting is currently underway. Each work group should be planning NOW for this event. Sydney, like every WGM, is a vital opportunity for co-chairs, editors, and project contributors to work face-to-face, and we are keen to work with all active contributors and their sponsors to ensure that this value proposition is maximized and clearly made.

If you cannot attend the Sydney Working Group Meeting, please ensure that enough co-chairs are present for your work group to meet quorum (as identified in your work group’s Decision Making Practices). If your work group needs to appoint an acting chair(s) to achieve quorum, this should be done no later than at the Cambridge meeting. Appointing an acting co-chair can be accomplished by bringing a formal motion before your work group for vote. Please note that GOM § 05.04 allows work groups to pass any formal motion with a simple majority vote. Your work group’s Decision Making Practices (DMPs) may require a higher threshold, in which case you should follow your DMPs.

Likewise, it is important for your work group to establish high level goals for the Sydney meeting while in Cambridge, and to post those goals during the Cambridge meeting or shortly thereafter. These high-level goals build and articulate the value proposition for the Sydney meeting. Making these visible and available as far in advance as possible is one of our best marketing opportunities.

We hope that all work groups will attend the Sydney meeting to address and advance the important business of HL7. Please feel free to contact either of us should you have questions, concerns, or need assistance with planning for the Sydney meeting.

Charlie McCay, Chair, HL7 Technical Steering Committee ([email protected]) John Quinn, Chief Technology Officer, HL7 ([email protected]) How should we address this; Electronic poll, face to face poll in Cambridge, or other means? Currently there have been 32 respondents to the doodle poll on RCRIM attendance in Sydney:

Yes, I plan to attend No, I will not be I may attend attending 5 18 9 Members of RCRIM are encouraged to respond prior to the close of the poll on October 1, 2010. If we cannot get a commitment to achieve quorum (10 plus a co-chair) we may choose not to meet in Sydney. You may participate in the poll at: http://www.doodle.com/nwr9x6g75t729prz Currently the only planned ballot for the January 2011 ballot cycle is the Study Design Implementation Guide.

V. Three Year Plan

RCRIM-Three year plan 2009 Update.xls

Attached is the current RCRIM three year plan. Please review your projects. The plan will be updated at the Cambridge business meeting (Q2 Wednesday)

VI. Other Business The CDISC to HL7 Message project has changed modeling facilitators. Gunther Schadow will assume the modeling facilitator role previously held by Jason Rock.

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