2011-08-30 RCRIM Call Minutes

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Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda

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Date: 2011-08-30
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 Patricia Garvey FDA
x Ed Helton NCI
x Joyce Hernandez Merck
x Jay Levine FDA
x Andrew Marr Marr Consultancy Ltd
x Armando Oliva FDA
x Steve Sandberg ScenPro
x John Speakman NCI
x Ed Tripp Edward S. Tripp and Associates
x Steve Ward Lilly
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 2011-06-07_RCRIM_Call_Minutes
  3. Approve SWOT Analysis
  4. Publication Request Needed
    1. HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” balloted in 2011 May
    2. HL7 Version 3 Domain Analysis Model: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” from 2009 January
    3. HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Design R1” from 2011 May
    4. HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 “ from the 2011 May
  5. Ballot Reconcilation Needed
    1. CDISC2MSG Study Design DAM from 2009 May
  6. Review WGM Agenda
  7. Other Items


Supporting Documents
RCRIM SWOT from 2011-08-02

Minutes

Minutes/Conclusions Reached:

  1. Agenda review and approval
    Agenda was accepted as presented
  2. Approve meeting minutes from 2011-06-07_RCRIM_Call_Minutes
    Minutes unanimously approved
  3. Approve SWOT Analysis
    Motion by Steve Ward, seconded by Ed Helton to approve the SWOT analysis
    Affirmative: 11
    Opposed: 0
    Abstain: 1
    Motion Carries
  4. Publication Request Needed
    1. HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” balloted in 2011 May
      Patty Garvey will discuss with Mitra Rocca. Material will be reviewed at the WGM
    2. HL7 Version 3 Domain Analysis Model: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” from 2009 January
      Patty Garvey will discuss with Mitra Rocca. Material will be reviewed at the WGM
    3. HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Design R1” from 2011 May
      Patty Garvey will discuss with Mitra Rocca. Material will be reviewed at the WGM
    4. HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 “ from the 2011 May
      Armando will discuss with Norman Gregory. Material will be reviewed at WGM
  5. Ballot Reconcilation Needed
    Patty Garvey and Mead Walker are meeting with the team this week to discuss ballot reconcilation on Subject Data. A decission on how best to move forward will be considered at the WGM
    1. CDISC2MSG Study Design DAM from 2009 May
    Patty Garvey and Mead Walker will discuss recomendations and questions raised by BRIDG harmonization. A determination on how to proceed with this ballot will be determined by the results of this discussion.
  6. Review WGM Agenda
    No changes were made to the agenda
  7. Other Items
    None
  • Adjourned 10:25 am Eastern.


Meeting Outcomes

Action Item Owner Due Date
CDISC to Message team will prepare publication requests and recomendation on ballot reconcilation for the WGM Patty Garvey 9/13/2011

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2011-08-30_RCRIM_Call_Minutes
  3. Action items from WGM
  4. Other Items


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