2011-12-20 RCRIM Call Minutes

Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda Location: Dial: 770-657-9270 Passcode: 7485962# 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: 2011-12-20 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 Buckler	BBMSC
x	Isabelle Davias	Sanofi Aventis
x	Kristi Eckerson	Emory University
x	Julie Evans	CDISC
x	Patricia Garvey	FDA
x	Ed Helton	NCI
x	Joyce Hernandez	Merck
x	Bron Kisler	CDISC
x	Rebecca Kush	CDISC
x	Jay Levine	FDA
x	Armando Oliva	FDA
x	Ed Tripp	Edward S. Tripp and Associates
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 2011-12-06_RCRIM_Call_Minutes
3. Approve BRIDG Ballot reconciliation
4. Project Scope Statement to convert the Study Design message to a Structured Document
5. Review Agenda for WGM
6. Other Items

Supporting Documents

• BRIDG Ballot reconciliation package

• Project Scope Statement - Study Design as a structured document

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   No additional agenda items

2. Approve meeting minutes from 2011-12-06 RCRIM Call Minutes

   Minutes unanimously approved.

3. Approve BRIDG Ballot reconciliation

   Julie Evans explained that all reconciliation has been reviewed with those who provided comments, except those for Gunther Schadow. Neither Julie or Don Lloyd have attempted to contact Gunther multiple times with no response. We will proceed with completing the reconciliation package

   Motion by Armando Oliva, seconded by Julie Evans to approve the BRIDG Ballot Reconciliation package (see supporting documents)

   VOTE:

   • Affirmative: 12
   • Negative: 0
   • Abstain: 0

   Motion carries

   Ed Tripp will record the vote on the spreadsheet and post the package to the ballot site.

4. Project Scope Statement to convert the Study Design message to a Structured Document

   Armando Oliva walked through the project scope statement.

   It was agreed we would amend item 2 Project Intent to "Create a New Standard"

   There was significant discussion around 4.a. Project Scope and 4.b. Project Need

   It was agreed that the document would be posted to the listserv and we would invite amendments through track changes between now and January 2, 2012. The revised document will be reviewed at the January 3, 2012 teleconference

   It was suggested that 4.d. Project Objectives / Deliverables / Target Dates. be amended to include the target for the IG ballot as well as the normative ballot. Armando will revise this section.

   Becky Kush raised a general concern that the CDISC/HL7 memorandum of understanding (MOU) expired in August. There is work going on to create a new MOU, however there is an issue of HL7 IP policy v.s. CDISC open use of standards. RCRIM should be aware that this is an open issue and Becky Kush, Ed Tripp and others will work with the HL7 CEO and Board to resolve this as quickly as possible. This also impacts Clinical Genomics and Patient Safety.

5. Review Agenda for WGM

   The BRIDG Update will be conducted by Becky Angeles. Ed will revise the agenda.

   Continued discussion of HL7 and CDISC Relationship and IP will be added to the Monday Q4 agenda

6. Other Items

   None

• Adjourned 10:59 a.m. Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Update WGM agenda for Q3 Monday	Ed Tripp	12/20/2011
Circulate the Project Scope Statement - Study Design as a structured document	Armando Oliva	12/20/2011

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2011-12-20_RCRIM_Call_Minutes
3. Project Scope Statement - Study Design as a structured document
4. Finalize Agenda for WGM
5. Other Items

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