2011-09-27 RCRIM Call Minutes

Return to RCRIM Teleconference Minutes and Agendas

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: 2011-09-27 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	Norman Gregory	FDA
x	Jay Levine	FDA
x	Armando Oliva	FDA
x	Steve Sandberg	ScenPro
x	John Speakman	NCI
x	Lise Stevens	FDA
x	Ed Tripp	Edward S. Tripp and Associates
x	Marti Velezis	Sonrisa Consulting
x	Diane Wold	GSK
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair

Agenda Topics

1. Agenda review and approval
2. Approve meeting minutes
   1. 2011-08-30_RCRIM_Call_Minutes
   2. 2011-09-13 RCRIM Minutes San Diego
   3. 2011-09-14 RCRIM Minutes San Diego
   4. 2011-09-15 RCRIM Minutes San Diego
3. Address comments on three year plan (if needed)
4. Project Scope Statement for Subject Data CDA IG
5. Approval of request to withdraw Abnormality Assessment
6. Discuss actions for current Study Design Ballot
7. Discuss timing on Withdrawal of Study Design and Study Participation DAM
8. Other Items

Supporting Documents
Three Year Plan 2011-09-20

Request to withdraw Abnormality Assessment

Minutes

Minutes/Conclusions Reached:

Agenda review and approval

Timeline for CRFQ was added after ‘’ Project Scope Statement for Subject Data CDA IG’’

Approve meeting minutes

• • 2011-08-30_RCRIM_Call_Minutes

'	Affirmate	Negative	Abstain
Votes	10	0	0
Result	Minutes Approved

• • Working Group Meeting Minutes A single vote was taken to approve all of the WGM minutes as a package

'	Affirmate	Negative	Abstain
Votes	10	0	0
Result	Minutes Approved

• 2011-09-13 RCRIM Minutes San Diego
• 2011-09-14 RCRIM Minutes San Diego
• 2011-09-15 RCRIM Minutes San Diego

Address comments on three year plan

The RCRIM Three Year Plan was approved via electronic vote with one negative and comment

Name	Date and Time	Comment
Joel Finkle	Tuesday, September 20, 2011 7:55:40 AM GMT-12:00	RPS should be shown as Regulated Product Submissions Release 2 Version 2 and Version 3, not Release 2 and Release 3. What is listed as Release 3 currently should be correct to handle the revisions needed based on the recent ballot comments.

It was suggested that the Three year plan be amended to add a parenthetical statement to RPSr3 “Regulated Product Submission Release 3 (Next ballot of release 2)” and submit the Three Year Plan Joel Finkle will revise the Regulated Product Submission Release 3 Project Scope Statement to amend the project name so that communications about the project are clear. The revised project scope statement will be placed on a future RCRIM Agenda.

Project Scope Statement for Subject Data CDA IG

Mead Walker has drafted a Project Scope Statement for Subject Data – Patient Narrative IG and Lise is following up to see when this can be circulated. As soon as it is available, Ed will post it for an RCRIM electronic vote using Doodle Poll. FDA reported that they cannot access doodle.com through their firewall. Lise will turn in a ticket. Ed Tripp will post a vote for anyone who cannot access the site if they provide an e-mail with their vote and comments (if any) until such time that the FDA members can access doodle.

Timeline for CRQF

Marti presented the following timeline

Date	Item
October 11, 2011	CRFQ – Present/Walk-though updated DSTU Content at RCRIM Teleconference
October 21, 2011	CRFQ – Submit Comments on DSTU Content
October 25, 2011	CRFQ – Review Comments on DSTU Content at RCRIM Teleconference
October 30, 2011	January 2012 Ballot: Notification of Intent to Ballot
November 6, 2011	January 2012 Ballot: Initial Ballot Content

Approval of request to withdraw Abnormality Assessment

Motion by Norman Gregory, seconded by Michael Brennan was made to approve the withdraw of Abnormality Assessment

'	Affirmative	Negative	Abstain
Votes	11	0	0
Result	Motion Carries

Discuss actions for current Study Design Ballot

We discussed the approach to use to for moving the Study Design Message to a structured document. The agreed upon plan is to leave the message in DSTU and initiate a new project to create a Structured Document Version of Study Design with Structured Documents as a co-sponsor. Mead Walker will draft the project scope statement.

Discuss timing on Withdrawal of Study Design and Study Participation DAM

At the WGM we discussed withdrawal of the two DAM’s and replacing them with a link to a project based view in BRIDG. Becky indicated the BRIDG Harmonization Package that has just been posted to the [www.bridgmodel.org www.bridgmodel.org ] website this week. Scroll down to the User Information section and then you will see the “Download the BRIDG Harmonization Package” link. The file in this package that will be of most help for the Study Participation and Study Design projects is “How to Build a BRIDG-Based Analysis Model.PDF.” Once there is a project specific BRIDG based Analysis Model, we will decide on how to move forward with replacing the current DAM’s

Other Items

None

• Adjourned 10:55 a.m. Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Send Withdrawal request on Abnormality Assessment to HL7 HQ	Ed Tripp	9/27/2011
Create PSS for Subject Data, Patient Narrative CDA IG	Mead Walker	9/30/2011
Create PSS for Study Design Structured Document	Mead Walker	9/30/2011
Establish plan to generate BRIDG based Analysis Model for Study Design and Study Participation	Lise Stevens	10/11/2011

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2011-09-27_RCRIM_Call_Minutes
3. Approve Publication Request for eStability IG
4. CRFQ – Present/Walk-though updated DSTU Content
5. Other Items

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