Return to RCRIM Teleconference Minutes and Agendas
Meeting Information
HL7 RCRIM Agenda
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Date: 2013-06-18
Time: 10:00-11:00 am Eastern Time
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| Facilitator
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Ed Tripp
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Note taker(s)
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Ed Tripp
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| Attendee
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Name
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Affiliation
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| x |
Crystal Allard |
FDA
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| x |
Barry Brown |
Mortara Instrument, Inc.
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| x |
Joel Finkle |
Image Solutions, Inc.
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| x |
Myron Finseth |
Medtronic
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| x |
Mark Gray |
FDA
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| x |
Ed Helton |
NCI
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| x |
Don Jaccard |
FDA
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| x |
Jared Lantzy |
FDA
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| x |
Behnaz Minaei |
FDA
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| x |
Armando Oliva |
FDA
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| x |
Jason Rock |
Global Submit
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| x |
Karin Sailor |
Medtronic
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| x |
Lise Stevens |
FDA
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| x |
Ed Tripp |
Edward S. Tripp and Associates
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| x |
Marti Velezis |
Sonrisa Consulting
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| x |
Mead Walker |
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| Quorum Requirements Met: YES
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quorum for RCRIM is 4 plus a co-chair
Agenda
Agenda Topics
- Agenda review and approval
- Approve Minutes from 2013-06-04
- Review RPS DSTU Results
- Review and approve RPS harmonization Proposal
- Review and approve RPS ballot plans
- Request for WGM Agenda change
- Other Items
Supporting Documents
RPS Harmonization Proposal for Status Code
Minutes
Minutes/Conclusions Reached:
- Agenda review and approval
- No additions or changes to agenda
- Review and Approve Minutes from 2013-06-04 Teleconference
- Standing Motion to approve minutes
- Affirmative - 15, Opposed - 0, Abstain - 0
- Motion carries
- 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
- 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
- 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
- Request for WGM Agenda change
- There was no time to address this. Item will be taken up at the 2013-07-02 RCRIM Teleconference.
- Other Items
- None
- Adjourned 11:05 a.m. Eastern.
Meeting Outcomes
| Action Item
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Owner
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Due Date
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| Post Harmonization Proposal |
D. Jaccard |
6/22/2013
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Next Meeting Preliminary Agenda Items
- Agenda review and approval
- Approve minutes from 2013-06-18
- Review and approve RPS harmonization Proposal (or withdraw)
- Request for WGM Agenda change
- Publishing Facilitator(s)
- Other Items
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