2011-04-12 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: 2011-04-12 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Becky Angeles	ScenPro
x	Joel Finkle	Image Solutions, Inc.
x	Patricia Garvey	FDA
x	Norman Gregory	FDA
x	Joyce Hernandez	Merck
x	Mary Lenzen	Octagon
x	Steve Sandberg	ScenPro
x	John Speakman	NCI
x	Ed Tripp	Edward S. Tripp and Associates
x	Wendy Ver Hoef	Scenpro
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 2011-03-29 RCRIM Call Minutes Clinical Lab Messaging Need for project lead to co-lead with Phil Participants who will help in the design the message and help with the V2.5.1 documentation Need for testers for the message BRIDG alignment of Study Design and Subject Data aECGr2 Project Scope (tentative) Review of WGM Agenda Other Items Supporting Documents RCRIM_Working_Group_Meeting_Agendas#Orlando.2C_FL_Working_Group_Meeting_May_2011 Minutes Minutes/Conclusions Reached: Agenda review and approval aECGr2 removed from agenda since there was no representation for the project Approve meeting minutes from 2011-03-29_RCRIM_Call_Minutes Minutes wer approved unanimously Clinical Lab Messaging Need for project lead to co-lead with Phil Participants who will help in the design the message and help with the V2.5.1 documentation Need for testers for the message Joyce indicated that section 7 of the O&O implementation guide for v2.5.1 lab message contains most if not all the information required for a Clinical Trials Lab message. If we leverage this work the project may not take a lot of effort. However, there is still a need to identify a co-lead for the project as well as parties who will participate in testing. There were no volunteers on the phone to participate in this project. Ed Tripp will send out a request through the RCRIM list serv. If there are no volunteers to work on this the project will not move forward. BRIDG alignment of Study Design and Subject Data Steve Sandberg reported that in conversations with Jay Levine and Lise Stevens an approach has been developed. Jan and Lise plan to review the story boards and use cases agaisnt Clinical Statement to determine what items from Clinical Statement need to be harmonized with BRIDG. This activity is expected to take a few months. Harmonization with BRIDG is expected to occurr in the June/July timeframe. Patty Garvey reported that a revised project scope statement for the CDISC to message project is expected within the next 10 days. The review of this scope statement is currently on the next RCRIM Teleconference agenda. Review of WGM Agenda Joel will inquire of RPS about the need for 2 quarters on Monday. Norman will lead the session on eStability IG Ed will inquire as to who will lead the session on CTR&R Steve will follow up with Julie and confirm that she can lead the BRIDG update Mitra will be at the meeting and lead the Study Design and Study Participation IG reconciliations Other Items None Adjourned 10:34 am Eastern. Meeting Outcomes Action Item Owner Due Date Follow up with RCRIM members on Clinical Trial Lab participation Ed Tripp 2011-04-12 Follow up with RPS members need for 2 quarters Monday at WGM Joel Finkel 2011-04-12 Follow up with Julie on lead for BRIDG review at WGM Steve Sandberg 2011-04-15 Provide revised CDISC to Message Project Scope Statement Patty Garvey 2011-04-19 Determine session leads for CTR&R at WGM Ed Tripp 2011-04-19 Next Meeting Preliminary Agenda Items 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 © 2010 Health Level Seven® International. All rights reserved.