2011-04-12 RCRIM Call Minutes

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Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda

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Date: 2011-04-12
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation


x Becky Angeles ScenPro
x Joel Finkle Image Solutions, Inc.
x Patricia Garvey FDA
x Norman Gregory FDA
x Joyce Hernandez Merck
x Mary Lenzen Octagon
x Steve Sandberg ScenPro
x John Speakman NCI
x Ed Tripp Edward S. Tripp and Associates
x Wendy Ver Hoef Scenpro
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 2011-03-29 RCRIM Call Minutes
  3. Clinical Lab Messaging
    1. Need for project lead to co-lead with Phil
    2. Participants who will help in the design the message and help with the V2.5.1 documentation
    3. Need for testers for the message
  4. BRIDG alignment of Study Design and Subject Data
  5. aECGr2 Project Scope (tentative)
  6. Review of WGM Agenda
  7. Other Items


Supporting Documents
RCRIM_Working_Group_Meeting_Agendas#Orlando.2C_FL_Working_Group_Meeting_May_2011


Minutes

Minutes/Conclusions Reached:

  1. Agenda review and approval
    aECGr2 removed from agenda since there was no representation for the project
  2. Approve meeting minutes from 2011-03-29_RCRIM_Call_Minutes
    Minutes wer approved unanimously
  3. Clinical Lab Messaging
    1. Need for project lead to co-lead with Phil
    2. Participants who will help in the design the message and help with the V2.5.1 documentation
    3. Need for testers for the message
      Joyce indicated that section 7 of the O&O implementation guide for v2.5.1 lab message contains most if not all the information required for a Clinical Trials Lab message. If we leverage this work the project may not take a lot of effort. However, there is still a need to identify a co-lead for the project as well as parties who will participate in testing. There were no volunteers on the phone to participate in this project. Ed Tripp will send out a request through the RCRIM list serv. If there are no volunteers to work on this the project will not move forward.
  4. BRIDG alignment of Study Design and Subject Data
    Steve Sandberg reported that in conversations with Jay Levine and Lise Stevens an approach has been developed. Jan and Lise plan to review the story boards and use cases agaisnt Clinical Statement to determine what items from Clinical Statement need to be harmonized with BRIDG. This activity is expected to take a few months. Harmonization with BRIDG is expected to occurr in the June/July timeframe.
    Patty Garvey reported that a revised project scope statement for the CDISC to message project is expected within the next 10 days. The review of this scope statement is currently on the next RCRIM Teleconference agenda.
  5. Review of WGM Agenda
    Joel will inquire of RPS about the need for 2 quarters on Monday.
    Norman will lead the session on eStability IG
    Ed will inquire as to who will lead the session on CTR&R
    Steve will follow up with Julie and confirm that she can lead the BRIDG update
    Mitra will be at the meeting and lead the Study Design and Study Participation IG reconciliations
  6. Other Items
    None
  • Adjourned 10:34 am Eastern.


Meeting Outcomes

Action Item Owner Due Date
Follow up with RCRIM members on Clinical Trial Lab participation Ed Tripp 2011-04-12
Follow up with RPS members need for 2 quarters Monday at WGM Joel Finkel 2011-04-12
Follow up with Julie on lead for BRIDG review at WGM Steve Sandberg 2011-04-15
Provide revised CDISC to Message Project Scope Statement Patty Garvey 2011-04-19
Determine session leads for CTR&R at WGM Ed Tripp 2011-04-19

Next Meeting Preliminary Agenda Items

  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


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