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Difference between revisions of "2013-06-18 RCRIM Call Minutes"

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| x||Don Jaccard||FDA
| x||Don Jaccard||FDA
| x||Julie James||Blue Wave Informatics and HL7 UK
| x||Jared Lantzy||FDA
| x||Jared Lantzy||FDA

Latest revision as of 10:45, 29 June 2013

Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda

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

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Date: 2013-06-18
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation
x Crystal Allard FDA
x Barry Brown Mortara Instrument, Inc.
x Joel Finkle Image Solutions, Inc.
x Myron Finseth Medtronic
x Mark Gray FDA
x Ed Helton NCI
x Don Jaccard FDA
x Julie James Blue Wave Informatics and HL7 UK
x Jared Lantzy FDA
x Behnaz Minaei FDA
x Armando Oliva FDA
x Jason Rock Global Submit
x Karin Sailor Medtronic
x Lise Stevens FDA
x Ed Tripp Edward S. Tripp and Associates
x Marti Velezis Sonrisa Consulting
x Mead Walker colspan="2"|
Quorum Requirements Met: YES
quorum for RCRIM is 4 plus a co-chair


Agenda Topics

  1. Agenda review and approval
  2. Approve Minutes from 2013-06-04
  3. Review RPS DSTU Results
  4. Review and approve RPS harmonization Proposal
  5. Review and approve RPS ballot plans
  6. Request for WGM Agenda change
  7. Other Items

Supporting Documents
RPS Harmonization Proposal for Status Code


Minutes/Conclusions Reached:

  1. Agenda review and approval
    No additions or changes to agenda
  2. Review and Approve Minutes from 2013-06-04 Teleconference
    Standing Motion to approve minutes
    Affirmative - 15, Opposed - 0, Abstain - 0
    Motion carries
  3. Review RPS DSTU Results
    Mark Gray provided the following overview
    After the DSTU ballot, ICH created a number of test cases to determine if the RPS model will meet the defined ICH requirements and RPS storyboards. Based on the testing, ICH requested a couple of minor tweaks to the model and also had a new requirement that resulted in adding confidentiality code to the model. In addition, the IMDRF group reviewed the model and requested some model changes. A summary of the model changes are provided below.
    • SubmissionUnit.componetOf.Sequence number is now optional
    • ContextOfUse: Link was removed: Note the removal was link was an agreement we made in the last ballot. Removal of link removes threaded communication.
    • ContextOfUse: setid is now optional
    • subjecOf.negationInd set default value = true. There was a ballot comment that the datatype and cardinality did not show. None of the Boolean values show the datatype.
    • Document: confidentiality code was added
    • ServiceDeliveryLocation was removed from Review
  4. Review and approve RPS harmonization Proposal
    Julie and Mead suggested that SUSPENDED is the appropriate status to be used in the scenarios described. It is currently in the RIM.
    Marti will take this information back to the stakeholders
    Don will post to the harmonization site and RCRIM will vote to approve or withdraw at meeting on 2013-07-02
  5. Review and approve RPS ballot plans
    Motion by Ed Helton, seconded by Mark Gray to approve RPS R2 v3 message balloting as normative along with the RPS R2 Implementation Guide as Informative in the September ballot cycle.
    Affirmative: 15 Opposed: 0 Abstain: 0
    Motion Carries
  6. Request for WGM Agenda change
    There was no time to address this. Item will be taken up at the 2013-07-02 RCRIM Teleconference.
  7. Other Items
  • Adjourned 11:05 a.m. Eastern.

Meeting Outcomes

Action Item Owner Due Date
Post Harmonization Proposal D. Jaccard 6/22/2013

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve minutes from 2013-06-18
  3. Review and approve RPS harmonization Proposal (or withdraw)
  4. Request for WGM Agenda change
  5. Publishing Facilitator(s)
  6. Other Items

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