2011-12-20 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda

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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


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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