2011-10-11 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: 2011-10-11 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Becky Angeles	ScenPro
x	Andrew Buckner	BBMSC
x	Joel Finkle	Image Solutions, Inc.
x	Patricia Garvey	FDA
x	Norman Gregory	FDA
x	Ed Helton	NCI
x	Jay Levine	FDA
x	Steve Sandberg	ScenPro
x	John Speakman	NCI
x	Ed Tripp	Edward S. Tripp and Associates
x	Julia Zhang	Genzyme
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair

Agenda

Agenda Topics

1. Agenda review and approval
2. Approve meeting minutes from 2011-09-27_RCRIM_Call_Minutes
3. Approve Publication Request for eStability IG
4. Approve PPS for CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives
5. Other Items

   • CRFQ – Present/Walk-though updated DSTU Content Next meeting or special call?

Supporting Documents
CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives Project Scope Statement

CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives Project Scope Statement-REVISED 2011-10-11

email from M. Brennan with comment and vote approving PPS for CDA IG

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   No changes to the agenda

2. Approve meeting minutes from 2011-09-27_RCRIM_Call_Minutes

   Unanimously approved

3. Approve Publication Request for eStability IG

   There are ongoing publication issues that are still being resolved with Mead Walker, Woody Beeler and Don Lloyd. This will be placed on the agenda for 2011-10-25

4. Approve PPS for CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives

   The changes provided by Patty Garvey were reviewed. The ballot date was amended to May 2012. The realm was changed to U.S. Realm.

   Motion by Ed Helton, seconded by Patty Garvey to approved the project scope statement as amended

   Affirmative: 10

   Opposed: 0

   Abstain: 0

   Motion Carries

   Approved document CDA IG for Patient Narratives revised and approved

   Ed Tripp will create a doodle poll for the DESD. Once approved (three weeks or quorum of 8 of the 15 work groups) it will be forwarded to the TSC for approval

5. Other Items

   • CRFQ – Present/Walk-though updated DSTU Content Next meeting or special call?

   Marti could not have the material prepared for today's call. She asked (via email) if we should have this presentation on the 2011-10-25 call or schedule an out of cycle call before 2011-10-25. The agenda for 2011-10-25 is full unless something if not ready on that day.

   Norman Gregory suggested we extend the time on the 2011-10-25 call by 30 minutes. All on the call agreed.

• Adjourned 10:37 a.m. Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Establish doodle poll for DESD approval of	Ed Tripp	10/11/2011
Update agenda for 2011-10-25 to add Approve Publication Request for eStability IG and CRFQ – Present/Walk-though updated DSTU Content	Ed Tripp	10/11/2011
Extend time for meeting on 2011-10-25 by 30 minutes	Ed Tripp	10/12/2011
Establish plan to generate BRIDG based Analysis Model for Study Design and Study Participation moved out 2 weeks	Lise Stevens	10/25/2011

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2011-10-11_RCRIM_Call_Minutes
3. Approve Publication Request for eStability IG
4. Approve RPS Ballot Reconciliation
5. BRIDG Ballot Reconciliation
6. CRFQ – Present/Walk-though updated DSTU Content
7. Other Items

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