2011-03-29 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda

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Date: 2011-03-29
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation

x Becky Angeles ScenPro
x Julie Evans CDISC
x Damien Francois Beth Israel Medical Center
x William Friggle Sanofi Aventis
x Patricia Garvey FDA
x Norman Gregory FDA
x Joyce Hernandez Merck
x Rebecca Kush CDISC
x Jay Levine FDA
x Jennifer Neat City of Hope
x Armando Oliva FDA
x Phil Pochon Covance
x Ed Helton NCI
x Jason Rock Global Submit
x Wendy Ver Hoef Scenpro
x Julia Zhang Genzyme
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 2011-03-01_RCRIM_Call_Minutes
  3. Periodic Reporting of Clinical Trials Laboratory Results (CTLab)
  4. Review and approval of RPSr3 Revised Project Scope Statement
  5. BRIDG as a DAM Update
  6. Other Items

Supporting Documents

  1. RPSr3 Revised Project Scope Statement


Minutes/Conclusions Reached:

  1. Agenda review and approval
    Order of agenda was revised to move the project scope statement behind the CTLab discussion
  2. Approve meeting minutes from 2011-03-01_RCRIM_Call_Minutes
    Minutes wer approved:
    • Affirmative 13
    • Negative 0
    • Abstain 4
  3. Periodic Reporting of Clinical Trials Laboratory Results (CTLab)
    Choice of action
    1. Withdraw this standard
    2. Initiate project of CTLab r2
    Phil Pochon gave an overview stating that we should look at leveraging O&O's work in lab messaging tailoring it to clinical trials. Phil suggested we withdraw the current message and begin a new project or projects rather than trying to update the current message.
    Jennifer Neat stated that there would be no objection to starting over with a new project
    Phil stated he would serve as one project lead provided that he had a co-lead to share the workload and responsibility. He suggested that we should look at two potential projects, a v2.5.1 IG as well as a v3 message. The work group could review the scope of both of these projects at the May WGM and discuss whether or not to approve either or both projects.
    Ed Tripp will provide Phil with the latest PSS Template and place Clinical Lab on the agenda for the WGM (Q2 Thursday) in the same session as the Clinical Genomics joint meeting.
    Motion by Julie Evans, seconded by Phil Pochon to withdraw the CTLab message.
    • Affirmative 10
    • Negative 0
    • Abstain 4
  4. Review and approval of RPSr3 Revised Project Scope Statement
    Jason Rock presented the revised Project Scope Statement (PSS). Key changes were the removal of threaded two way communication and the removal of hyperlinking issues from the scope of development.
    Motion by Jason Rock, seconded by Ed Helton to approved the revised PSS.
    • Affirmative 7
    • Negative 0
    • Abstain 7
  5. BRIDG as a DAM Update
    Julie Evans stated that the ISO/JIC ballot passed last year. The material for the next ballot was submitted to ISO but need to be amended. Therefore, the next ballot has been moved to end concurrent with HL7 September ballot (rather than May 2011 as originally scheduled)
    Ed displayed the schedule from the current BRIDG as a DAM PSS (see Displayed Table below)
    Julie stated the BRIDG Board is currently working on prioritization of future harmonization work. Also the Board has determined that BRIDG is a logical model as it relates to SAIF. There are also web site improvements that are underway as well as a quarterly newsletter. Current activity includes harmonization of the Bone Marrow Transplant standard from NCI and the RCRIM Study Design Message. Julie indicated that she saw a number of issues trying to harmonize Study Desgin.
    Jay Levine stated that he believed there were very few issues but the one major stumbling block was the lack of a modeler assigned to this project.
    Patty Garvey indicated that there were still discussion at FDA on whether to withdraw the current Subject Data ballot or reconcile it. The team still needs to assure that thier requirements are communicated to the CDA r3 project.
    Due to lack of time BRIDG alighment of Study Design and Subject Data will be on the next agenda
  6. Other Items
  • Adjourned 11:04 am Eastern.

Displayed Table

Standard or Planned Message RCRIM Status Currently in BRIDG? Date to Ballot in BRIDG2
ISO JIC Ballot, including HL7 ballot Not applicable NA May-2010
ANSI/HL7 RPS, R1-2008 Approved Normative Yes May-2010
HL7 CDISC3MSG SP, R1 Current Project Yes May-2010
Periodic Reporting of Clinical Trial Laboratory Data, Release 2 Approved DSTU Yes May-2010
Laboratory Test Result Abnormality Assessment Approved DSTU Yes May-2010
HL7 CDISC3MSG SD, R1 Current Project No May-2011
HL7 CDISC3MSG Subject Data, R1 Current Project No May-2011
Clinical Trial Registration and Reporting Current Project No May-2011
HL7 Version 3 Standard: Regulated Product Submission, Release 2 Current Project No May-2012
ANSI/HL7 V3 ECG,R1-2004 Approved Normative No May-2012
HL7 DSR (eStability), R2 Approved DSTU No May-2012
HL7 SPL, R4 Approved Normative No May-2013
HL7 Version 3 Standard: Regulated Product Submission, Release 3 Future Project No May-2013
HL7 V3 CRFQ,R1 Approved DSTU No May-2013
Medical Product and Device Listing (2 Phases) Current Project No May-2013

Meeting Outcomes

Action Item Owner Due Date
Provide Phil Pochon with latest Project Scope Template Ed Tripp 2011-03-29
Update WGM Agenda with Clinical Lab Message Discussion Q4 Thurs. Ed Tripp 2011-03-29

Next Meeting Preliminary Agenda Items

  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 V3 message and help with the V2.5.1 documentation
    3. Need for testers for the V3 message
  4. BRIDG alighment of Study Design and Subject Data
  5. aECGr2 Project Scope (tentative)
  6. Other Items

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