2011-04-26 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda

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Date: 2011-04-26
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 William Friggle Sanofi Aventis
x Patricia Garvey FDA
x Norman Gregory FDA
x Bron Kisler CDISC
x Rebecca Kush CDISC
x Jay Levine FDA
x Armando Oliva FDA
x Ed Helton NCI
x Ed Tripp Edward S. Tripp and Associates
x Wendy Ver Hoef Scenpro
x Steve Sandberg ScenPro
x Steve Ward Lilly
x Julia Zhang Genzyme
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair

Agenda

Agenda Topics

  1. Agenda review and approval
  2. Approve meeting minutes from 2011-04-12_RCRIM_Call_Minutes
  3. Review Revised Project Scope Statement for CDISC to Message
  4. Review WGM Agenda
  5. Other Items


Supporting Documents
RCRIM_Working_Group_Meeting_Agendas#Orlando.2C_FL_Working_Group_Meeting_May_2011

CDISC to Message Revised PSS


Minutes

Minutes/Conclusions Reached:

  1. Agenda review and approval
    No changes to the agenda
  2. Approve meeting minutes from 2011-04-12_RCRIM_Call_Minutes
    Minutes wer approved unanimously
  3. Review Revised Project Scope Statement for CDISC to Message
    A revised project scope statement (PSS) was presented. The PSS needs to be updated and placed in the new HL7 PSS Template. The question was raised whether the Study Design and Study Participation standards were to remain as v3 messages or be redeveloped as CDA's. FDA still needs to test the Study Design and Study Participation messages so for now they will remain as v3 messages and continue as a DSTU. It was stated that the Project Deliverable schedule should show a taget date for BRIDG Harmonization. Concern was expressed that Study Design and Subject data utilize Clinical Statement and that made BRIDG Harmonization difficult. Armando indicated that ICSR utilizes Clinical Statement and that it was Harmonized to BRIDG by constraining Clinical Statement to what was necessary for ICSR. FDA is working to constrain Clinical Statement as used for study Design and will keep the BRIDG SCC updated.
    FDA also stated that the current intent is to reconcile the Subject Data Message as balloted in the September 2009 ballot. Subsequent to the meeting Ed Tripp discovered that a ballot reconciliation package had been posted to the ballot site stating "This Standard is being withdrawn. Requirements have been submitted for inclusion in CDAr3. CDAr3 will be used to transmit the information required for Subject Data once it achieves Normative Status." Ed Tripp will remove the reconcilation package from the ballot site and inform all voters that reconciliation will be proceding.
    Patty will update the PSS and cirulate it to the list serv for review a week prior to the May 10, 2011 teleconference.
  4. Review WGM Agenda
    The Work Group is reminded that there are co-chair elections for two open positions. Ed Helton is running as a write-in candidate. Anyone else wishing to run as a write-in is encouraged to get a message stating thier intent to the membership through the list serv.
    There has been a request to move the Wednesday Q4 session ealier in the day. Ed Tripp will follow up with Mitra Roca to see if she can accomodate the request.
    RPS still has not identified anyone to present a project update. Ed Tripp will reach out to some of the leadership team.
  5. Other Items
    None
  • Adjourned 10:57 am Eastern.


Meeting Outcomes

Action Item Owner Due Date
Remove ballot reconciliation from Subject Data Ballot and notify voters Ed Tripp 2011-04-27
Follow up with RPS members Ed Tripp 2011-04-27
Revise and distribute revised CDISC to Message PSS Patty Garvey 2011-05-03
Resolve request to Change Quarters on Wednesday Ed Tripp 2011-04-27

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2011-04-26_RCRIM_Call_Minutes
  3. Review Revised Project Scope Statement for CDISC to Message
  4. Request to Publish SPLr5 DSTU
  5. Review WGM Agenda
  6. Other Items

Supporting Documents
RCRIM_Working_Group_Meeting_Agendas#Orlando.2C_FL_Working_Group_Meeting_May_2011


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