2011-04-26 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda Location: Dial: 770-657-9270 Passcode: 745896# Webex Info: Go to https://estripp.webex.com/estripp/j.php?ED=129183437&UID=0&PW=NNzQ1Nzg4NGZj&RT=MiM3 If requested, enter your name and email address. If a password is required, enter the meeting password: RCRIM		Date: 2011-04-26 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Becky Angeles	ScenPro
x	Michael Brennan	Johnson and Johnson
x	Joel Finkle	Image Solutions, Inc.
x	William Friggle	Sanofi Aventis
x	Patricia Garvey	FDA
x	Norman Gregory	FDA
x	Bron Kisler	CDISC
x	Rebecca Kush	CDISC
x	Jay Levine	FDA
x	Armando Oliva	FDA
x	Ed Helton	NCI
x	Ed Tripp	Edward S. Tripp and Associates
x	Wendy Ver Hoef	Scenpro
x	Steve Sandberg	ScenPro
x	Steve Ward	Lilly
x	Julia Zhang	Genzyme
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair Agenda Agenda Topics Agenda review and approval Approve meeting minutes from 2011-04-12_RCRIM_Call_Minutes Review Revised Project Scope Statement for CDISC to Message Review WGM Agenda Other Items Supporting Documents RCRIM_Working_Group_Meeting_Agendas#Orlando.2C_FL_Working_Group_Meeting_May_2011 CDISC to Message Revised PSS Minutes Minutes/Conclusions Reached: Agenda review and approval No changes to the agenda Approve meeting minutes from 2011-04-12_RCRIM_Call_Minutes Minutes wer approved unanimously Review Revised Project Scope Statement for CDISC to Message A revised project scope statement (PSS) was presented. The PSS needs to be updated and placed in the new HL7 PSS Template. The question was raised whether the Study Design and Study Participation standards were to remain as v3 messages or be redeveloped as CDA's. FDA still needs to test the Study Design and Study Participation messages so for now they will remain as v3 messages and continue as a DSTU. It was stated that the Project Deliverable schedule should show a taget date for BRIDG Harmonization. Concern was expressed that Study Design and Subject data utilize Clinical Statement and that made BRIDG Harmonization difficult. Armando indicated that ICSR utilizes Clinical Statement and that it was Harmonized to BRIDG by constraining Clinical Statement to what was necessary for ICSR. FDA is working to constrain Clinical Statement as used for study Design and will keep the BRIDG SCC updated. FDA also stated that the current intent is to reconcile the Subject Data Message as balloted in the September 2009 ballot. Subsequent to the meeting Ed Tripp discovered that a ballot reconciliation package had been posted to the ballot site stating "This Standard is being withdrawn. Requirements have been submitted for inclusion in CDAr3. CDAr3 will be used to transmit the information required for Subject Data once it achieves Normative Status." Ed Tripp will remove the reconcilation package from the ballot site and inform all voters that reconciliation will be proceding. Patty will update the PSS and cirulate it to the list serv for review a week prior to the May 10, 2011 teleconference. Review WGM Agenda The Work Group is reminded that there are co-chair elections for two open positions. Ed Helton is running as a write-in candidate. Anyone else wishing to run as a write-in is encouraged to get a message stating thier intent to the membership through the list serv. There has been a request to move the Wednesday Q4 session ealier in the day. Ed Tripp will follow up with Mitra Roca to see if she can accomodate the request. RPS still has not identified anyone to present a project update. Ed Tripp will reach out to some of the leadership team. Other Items None Adjourned 10:57 am Eastern. Meeting Outcomes Action Item Owner Due Date Remove ballot reconciliation from Subject Data Ballot and notify voters Ed Tripp 2011-04-27 Follow up with RPS members Ed Tripp 2011-04-27 Revise and distribute revised CDISC to Message PSS Patty Garvey 2011-05-03 Resolve request to Change Quarters on Wednesday Ed Tripp 2011-04-27 Next Meeting Preliminary Agenda Items Agenda review and approval Approve meeting minutes from 2011-04-26_RCRIM_Call_Minutes Review Revised Project Scope Statement for CDISC to Message Request to Publish SPLr5 DSTU Review WGM Agenda Other Items Supporting Documents RCRIM_Working_Group_Meeting_Agendas#Orlando.2C_FL_Working_Group_Meeting_May_2011 © 2010 Health Level Seven® International. All rights reserved.