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2011-06-07 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda

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Date: 2011-06-07
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation
x Patricia Garvey FDA
x Terry Hardin Parexel
x Ed Helton NCI
x Bron Kisler CDISC
x Mary Lenzen Octagon
x Jay Levine FDA
x Andrew Marr Marr Consultancy Ltd
x Armando Oliva FDA
x Mitra Rocca FDA
x Steve Sandberg ScenPro
x Lise Stevens FDA
x Ed Tripp Edward S. Tripp and Associates
x Wendy Ver Hoef Scenpro
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair


Agenda Topics

  1. Agenda review and approval
  2. Approve meeting minutes from
    Monday May 16, 2011
    Tuesday May 17, 2011
    Wednesday May 18, 2011
    Thursday May 19, 2011
  3. Update on CDISC to Message PSS
  4. Plan SD WGM Agenda
  5. Other Items

Supporting Documents


Minutes/Conclusions Reached:

  1. Agenda review and approval
    Added to the agenda was a discussion about the next scheduled teleconference on June 21, 2011
  2. Approve meeting minutes from
    • Minutes for 2011-05-10 were unanimously approved
    Monday May 16, 2011
    Tuesday May 17, 2011
    Wednesday May 18, 2011
    Thursday May 19, 2011
    • Minutes for the WGM were voted on as a single item
    Affirmative: 9
    Negative: 0
    Abstain: 2
    • Minutes for the May WGM Approved
  3. Update on CDISC to Message PSS
    Lise Stevens provided the following update
    • FDA would still like to continue with the ballot reconciliation process to:
    1. formally close this activity for subject data,
    2. ensure that specification captures FDA requirements and
    3. determine the modeling construct issues - this would be consolidated with modeling comments received for the Study Participation and Study Design IGs.
    • In addition, going through this ballot reconciliation process and internal mapping exercise (mapping to SDTM V3.1.2 and SEND V3.0, and new SDTM device domains being balloted within CDISC) will help to address questions from BRIDG regarding how FDA intends to use the Clinical Statement Pattern (CSP) and does it need to be constrained. CSP is used in both study design and subject data. The current CDA r2 CSP is only for clinical documents for human patients but FDA has other uses cases - devices, non-human subjects, etc. If FDA decides to use CDA r2, then we would have to ballot an IG for human subjects.
    • In moving forward, Ed Tripp will arrange a joint tcon with Structured Documents (SD) a few weeks before the September HL7 meeting in San Diego. At this tcon, we should be able to share our FDA requirements that SD can include in CDA r3. The outcomes from this tcon, (including the HL7 work plan for closing the DSTUs and balloting of CDAs) will be shared during the project working group session at the September HL7 meeting. In addition, a representative from Structured Documents will be invited to give a tutorial on CDA. Lise will contact me to Mead to ensure that he will be available to participate in these discussions
  4. Plan SD WGM Agenda
    • RPS has requested two quarters close together to reconcile the RPS r2D2 ballot. They are penciled in on Tuesday Q4 and Wednesday Q1.
    • The CDISC to Message session is penciled in for Tuesday Q2 but Mead Walker is an essential participant. Ed will work with Mead to find an appropriate quarter if Mead is unavailable on Tuesday Q2.
    • It is desirable to have a joint session with Structured Documents, rooms have already been reserved. Ed will work with SDWG to see if there is a mutual time where both WG’s are open or can rearrange to open their schedule.
  5. Next Teleconference
    • Due to attendance of many RCRIM members at the DIA Annual Meeting, the next scheduled teleconference on June 21, 2011 will be canceled. The next call will take place on July 5, 2011.
  6. Other Items
  • Adjourned 10:53 am Eastern.

Meeting Outcomes

Action Item Owner Due Date
Work with Mead Walker to schedule Quarter for CDISC to Message Ed Tripp 6/10/2011
Schedule a joint call with Structured Documents for September (prior to WGM) Ed Tripp 6/17/2011
Publish tentative agenda for RCRIM on wiki Ed Tripp 6/10/2011
Attempt to schedule joint session with SDWG for San Diego Ed Tripp 6/17/2011
Revise and distribute revised CDISC to Message PSS Patty Garvey TBD

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2011-06-07_RCRIM_Call_Minutes
  3. Review WGM Agenda
  4. Other Items

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