2012-02-14 RCRIM Call Minutes

From HL7Wiki
Jump to: navigation, search


Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda

Location: Dial: 770-657-9270 Passcode: 7485962#

WebEx Info:

  1. Go to https://estripp.webex.com/estripp/j.php?ED=129183437&UID=0&PW=NNzQ1Nzg4NGZj&RT=MiM3
  2. If requested, enter your name and email address.
  3. If a password is required, enter the meeting password: RCRIM
Date: 2012-02-14
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 Ed Helton NCI
x Bron Kisler CDISC
x Jay Levine FDA
x Armando Oliva FDA
x Steve Sandberg ScenPro
x Ed Tripp Edward S. Tripp and Associates
x Mead Walker Mead Walker Consulting
x Steve Ward Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair

Agenda

Agenda Topics

  1. Agenda review and approval
  2. Approve meeting minutes from 2012-01-03 RCRIM Call Minutes
  3. Discuss proposed edit to Wednesday Q1 WGM minutes
  4. Approve meeting minutes from San Antonio WGM
  5. Review Agenda for WGM
    1. discuss approache to Information mapping and gap/impact analysis for clinical process
  6. Other Items


Supporting Documents


Minutes

Minutes/Conclusions Reached:

  1. Agenda review and approval
    No additional agenda items
  2. Approve meeting minutes from 2012-01-03 RCRIM Call Minutes
    Affirmative - 9
    Opposed - 0
    Abstain - 1
    Minutes approved.
  3. Discuss proposed edit to Wednesday Q1 WGM minutes
    Upon review of the WGM Minutes for Wednesday Q1 at San Antonio, it was noted that the recommendation for disposition is not appropriate. Per the instructions on the reconciliation sheet "6. Referred and Tracked. This should be used in circumstances when a comment was submitted to your WG in error and should have been submitted to another WG. If you use this disposition you should also select the name of the WG you referred the comment to under the Column "Referred To"."
    Ed Tripp suggested the following note be added to the Meeting Minutes:
    NOTE: Upon review of the minutes it was noted that “Referred and Tracked” is not an appropriate disposition. At the teleconference on February 14, 2012, the RCRIM WG amended the minutes to state the comments will be marked “Consider for Future Use”. This relates to the three topic areas from Keith Thomas. The RPS team has been informed of the change.
  4. Approve meeting minutes from San Antonio WGM
    Motion by Armando Oliva, seconded by Michael Brennan to approve all minutes for the San Antonio WGM with the changes to Q1 Wednesday noted above.
    Affirmative - 10
    Opposed - 0
    Abstain - 0
    Minutes approved.
  5. Review Agenda for WGM
    RCRIM_Working_Group_Meeting_Agendas#Vancouver.2C_BC.2C_Canada.2C_Working_Group_Meeting_May_2012
    1. discuss approach to Information mapping and gap/impact analysis for clinical process
    The team discussed different approaches to working on an information map that highlights where there are needs for information exchange. Mead Walker and Michael Brennan made several suggestions including starting with a High Level process that describes a drug product life-cycle, identifying where exchanges exist and potential opportunities for exchanges. We should document the "why" for the exchange and whether it is uni-directional or bi-directional.
    Mead Walker, Micheal Brennan and Ed Tripp volunteered to work on a first pass, high level map and bring it back to the RCRIM WG in 4 weeks.
  6. Other Items
    None
  • Adjourned 10:37 a.m. Eastern.

Meeting Outcomes

Action Item Owner Due Date
Develop a first pass, high level process map of the drug development life-cycle as a starting point for identification of information exchange points Michael Brennan, Ed Tripp, Mead Walker 3/13/2012

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2012-02-14_RCRIM_Call_Minutes
  3. Other Items

© 2010 Health Level Seven® International. All rights reserved.

Copyright © Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher.