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2011-10-25 RCRIM Call Minutes

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Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda

Location: Dial: 770-657-9270 Passcode: 745896#

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Date: 2011-10-11
Time: 10:00-11:30 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 William Friggle Sanofi Aventis
x Patricia Garvey FDA
x Norman Gregory FDA
x Ed Helton NCI
x Jay Levine FDA
x Armando Oliva FDA
x Steve Sandberg ScenPro
x Keith Thomas i4i
x Ed Tripp Edward S. Tripp and Associates
x Marti Velezis Sonrisa Consulting
x Mead Walker Mead Walker Consulting
x Steve Ward Lilly
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 2011-10-11_RCRIM_Call_Minutes
  3. Approve Harmonization proposals from RPS
    1. RPS Document Status And Relationship
    2. RPS Integrity Check Algorithm
    3. RPS Regulatory Category
    4. RPS Context of Use
    5. RPS Document Type
    6. RPS Keyword
    7. RPS Regulatory Status
  4. Approve Publication Request for eStability IG
  5. Approve RPS Ballot Reconciliation
  6. BRIDG Ballot Reconciliation
  7. CRFQ – Present/Walk-though updated DSTU Content
  8. Other Items


Supporting Documents
Harmonization Proposal - RPS Document Status And Relationship

Harmonization Proposal - RPS Integrity Check Algorithm

Harmonization Proposal - RPS Regulatory Category

Harmonization Proposal - RPS Context of Use

Harmonization Proposal - RPS Document Type

Harmonization Proposal - RPS Keyword

Harmonization Proposal - RPS Regulatory Status

Minutes

Minutes/Conclusions Reached:

  1. Agenda review and approval
    Publication Request for eStability IG is not available at this time. This will be placed on the November 8, 2011 agenda.
    Approve RPS Ballot Reconciliation needs to be moved to the next meeting, but needs to be approved on November 8, 2011 in order to meet the deadline for the publishing calendar.
    BRIDG Ballot Reconciliation will be delayed until the next meeting. No representative was available on the call.
    We will not approve Harmonization proposals but review the material posted.
    Under other items, add approval of items for ballot
  2. Approve meeting minutes from 2011-10-11_RCRIM_Call_Minutes
    Vote to approve Minutes:
    Affirmative - 13
    Negative - 0
    Abstain -1
    Motion Carries
  3. Review Harmonization proposals from RPS
    Keith Thomas walked the group through each of the proposals
    1. RPS Document Status And Relationship
      This will not be considered until completion of DSTU activity
    2. RPS Integrity Check Algorithm
      • This proposal will be withdrawn
      • Mead Walker provided advice on how to frame the 5 requests below, to indicate that there will be multiple value sets associated with each domain. Mead thought the HL7 plan was that each concept domain would have multiple attached value sets, by realm or finer granularity, and the fact that no current examples are can be found only indicates the RPS is ahead of the pack.
    3. RPS Regulatory Category
    4. RPS Context of Use
    5. RPS Document Type
    6. RPS Keyword
    7. RPS Regulatory Status
  4. CRFQ – Present/Walk-though updated DSTU Content
    Marti provided a brief walkthrough. The material will go forward for ballot with no changes from the current DSTU material. Marti indicated that she is aware that there is a need for changes related to representation and other supporting material but that the material content does not require changes. Therefore, Marti intends to vote negative on the DSTU ballot and provide comments on areas that need to be updated.
  5. Other Items
    1. Items for Ballot
      A motion was made by Bill Friggle, seconded by Patty Garvey to approve RPS, CRFQ and CDA IG for Patient Narratives for the January ballot.
      Affirmative – 9
      Opposed – 0
      Abstain – 1
      No Vote – 1
      Motion Carries
  • Adjourned 11:26 a.m. Eastern.

Meeting Outcomes

Action Item Owner Due Date
Post NIB’s for approved ballots Ed Tripp 10/30/2011
Update agenda for 2011-11-08 to add Approve Publication Request for eStability IG, RPS Ballot Reconciliation and BRIGD Ballot Reconciliation Ed Tripp 10/28/2011

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2011-10-25_RCRIM_Call_Minutes
  3. Proposed Revisions to RPS PSS (project #539)
  4. Approve Publication Request for eStability IG
  5. RPS Ballot Reconciliation
  6. BRIGD Ballot Reconciliation
  7. Establish plan to generate BRIDG based Analysis Model for Study Design and Study Participation
  8. Review Agenda for WGM
  9. Other Items


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