2012-01-03 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda

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Date: 2012-01-02
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation
x Becky Angeles ScenPro
x Kristi Eckerson Emory University
x Julie Evans CDISC
x William Friggle Sanofi Aventis
x Norman Gregory FDA
x Ed Helton NCI
x Bron Kisler CDISC
x Rebecca Kush CDISC
x Jay Levine FDA
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 Clyde Ulmer FDA
x Mead Walker Mead Walker Consulting
x Steve Ward Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair


Agenda Topics

  1. Agenda review and approval
  2. Approve meeting minutes from 2011-12-20_RCRIM_Call_Minutes
  3. Review PSS Study Design Structured Document
  4. Review Agenda for WGM
  5. Other Items

Supporting Documents


Minutes/Conclusions Reached:

  1. Agenda review and approval
    No additional agenda items
  2. Approve meeting minutes from 2011-12-20 RCRIM Call Minutes
    Affirmative - 16
    Opposed - 0
    Abstain - 1
    Minutes approved.
  3. Review PSS Study Design Structured Document
    Armando Oliva walked through the updated project scope statement (see supporting documents)
    CDISC provided comments from a combined review. The first area of concern was specifying the v3 message as the starting point with no mention of BRIDG. The first sentence of section 4.a. Project Scope was revised to read The project will take relevant existing material from Study Design V3 message – currently a DSTU and BRIDG– as a starting point.
    A suggestion was made to make BRIDG harmonization a deliverable. This was concerning to a number of FDA team members who stated that it was difficult to impossible to predict the duration of that activity and that they would like to see The clinical statement pattern harmonization with BRIDG listed in dependencies.
    Steve Ward suggested that the CTR&R Project Scope statement handled the question of BRIDG harmonization well and should be used as a model for this PSS.The CTR&R PSS lists Utilize the RCRIM BRIDG model in the analysis process and extend, as needed, to meet trial registry and result database requirements as item one under deliverables with no data associated with it.
    There were a number of other comments from CDISC that could not be addressed in the time allotted for the teleconference. The following actions were agreed to
    • CDISC will finish editing their comments and distribute the PSS with comments to the RCRIM Listserv this week. - B. Kush
    • All other comments should be also posted the the RCRIM Listserv no later than January 13, 2012. - RCRIM Members
    • FDA will compile comments in spreadsheet or other organized format for review at the WGM - P. Garvey
    • RCRIM WGM Meeting to be revised to include a review of the PSS Study Design Structured Document on Q3 Wednesday - E. Tripp
  4. Review Agenda for WGM
    There was no time for this agenda item. RCRIM members were encouraged to e-mail Ed Tripp with any request for changes.
  5. Other Items
  • Adjourned 11:11 a.m. Eastern.

Meeting Outcomes

Action Item Owner Due Date
Update WGM agenda for Q3 Wednesday Ed Tripp 1/3/2012
Provide CDISC comments on PSS Study Design Structured Document to RCRIM Listserv Becky Kush 1/6/2012
Provide additional comments on PSS Study Design Structured Document to RCRIM Listserv All 1/13/2012
Compile comments on PSS Study Design Structured Document for review at WGM P. Garvey 1/17/2012

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2012-01-03_RCRIM_Call_Minutes
  3. Other Items

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