2011-06-07 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: 2011-06-07 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Patricia Garvey	FDA
x	Terry Hardin	Parexel
x	Ed Helton	NCI
x	Bron Kisler	CDISC
x	Mary Lenzen	Octagon
x	Jay Levine	FDA
x	Andrew Marr	GSK
x	Armando Oliva	FDA
x	Mitra Rocca	FDA
x	Steve Sandberg	ScenPro
x	Lise Stevens	FDA
x	Ed Tripp	Edward S. Tripp and Associates
x	Wendy Ver Hoef	Scenpro
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair Agenda Agenda Topics Agenda review and approval Approve meeting minutes from 2011-05-10_RCRIM_Call_Minutes Monday May 16, 2011 Tuesday May 17, 2011 Wednesday May 18, 2011 Thursday May 19, 2011 Update on CDISC to Message PSS Plan SD WGM Agenda Other Items Supporting Documents None Minutes Minutes/Conclusions Reached: Agenda review and approval Added to the agenda was a discussion about the next scheduled teleconference on June 21, 2011 Approve meeting minutes from 2011-05-10_RCRIM_Call_Minutes Minutes for 2011-05-10 were unanimously approved Monday May 16, 2011 Tuesday May 17, 2011 Wednesday May 18, 2011 Thursday May 19, 2011 Minutes for the WGM were voted on as a single item Affirmative: 9 Negative: 0 Abstain: 2 Minutes for the May WGM Approved Update on CDISC to Message PSS Lise Stevens provided the following update FDA would still like to continue with the ballot reconciliation process to: formally close this activity for subject data, ensure that specification captures FDA requirements and determine the modeling construct issues - this would be consolidated with modeling comments received for the Study Participation and Study Design IGs. In addition, going through this ballot reconciliation process and internal mapping exercise (mapping to SDTM V3.1.2 and SEND V3.0, and new SDTM device domains being balloted within CDISC) will help to address questions from BRIDG regarding how FDA intends to use the Clinical Statement Pattern (CSP) and does it need to be constrained. CSP is used in both study design and subject data. The current CDA r2 CSP is only for clinical documents for human patients but FDA has other uses cases - devices, non-human subjects, etc. If FDA decides to use CDA r2, then we would have to ballot an IG for human subjects. In moving forward, Ed Tripp will arrange a joint tcon with Structured Documents (SD) a few weeks before the September HL7 meeting in San Diego. At this tcon, we should be able to share our FDA requirements that SD can include in CDA r3. The outcomes from this tcon, (including the HL7 work plan for closing the DSTUs and balloting of CDAs) will be shared during the project working group session at the September HL7 meeting. In addition, a representative from Structured Documents will be invited to give a tutorial on CDA. Lise will contact me to Mead to ensure that he will be available to participate in these discussions Plan SD WGM Agenda RPS has requested two quarters close together to reconcile the RPS r2D2 ballot. They are penciled in on Tuesday Q4 and Wednesday Q1. The CDISC to Message session is penciled in for Tuesday Q2 but Mead Walker is an essential participant. Ed will work with Mead to find an appropriate quarter if Mead is unavailable on Tuesday Q2. It is desirable to have a joint session with Structured Documents, rooms have already been reserved. Ed will work with SDWG to see if there is a mutual time where both WG’s are open or can rearrange to open their schedule. Next Teleconference Due to attendance of many RCRIM members at the DIA Annual Meeting, the next scheduled teleconference on June 21, 2011 will be canceled. The next call will take place on July 5, 2011. Other Items None Adjourned 10:53 am Eastern. Meeting Outcomes Action Item Owner Due Date Work with Mead Walker to schedule Quarter for CDISC to Message Ed Tripp 6/10/2011 Schedule a joint call with Structured Documents for September (prior to WGM) Ed Tripp 6/17/2011 Publish tentative agenda for RCRIM on wiki Ed Tripp 6/10/2011 Attempt to schedule joint session with SDWG for San Diego Ed Tripp 6/17/2011 Revise and distribute revised CDISC to Message PSS Patty Garvey TBD Next Meeting Preliminary Agenda Items Agenda review and approval Approve meeting minutes from 2011-05-10_RCRIM_Call_Minutes Review Revised Project Scope Statement for CDISC to Message Other Items © 2010 Health Level Seven® International. All rights reserved.