€¦ · Web view2013/05/08 · Wednesday Q1 Study Participation Ballot reconciliation....

HL7 RCRIM Working Group Meeting MinutesMay 8, 2013

Wednesday Q1 Study Participation Ballot reconciliationAttendees-In personFirst Name Last Name Affiliation E-mail AddressCrystal Allard FDA [email protected] Brown Mortara Instrument, Inc. [email protected] Helton NCI [email protected] Kiser Abbvie [email protected] Oliva FDA [email protected] Tripp Edward S. Tripp and Associates [email protected] Walker Mead Walker Consulting [email protected]

I. HL7 Version 3 Standard: Regulated Studies; CDISC Content to Message - Study Participation, Release 1The ballot results were

Aff. Neg. Abst. NVAffiliate 1 0 54 5Consultant 2 0 3 1Government/Non-Profit 10 0 1 1Payor 0 0 0 0Pharmaceutical 1 2 1 1Provider 12 0 18 8Vendor 1 0 13 2Totals 27 2 90 18% of Votes 19.71% 1.46% 65.69% 13.14%Quorum 86.86%Approval 22

The negatives comments from Dianne Wold and Bill Friggle were reviewed.

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Mead moved that we consider Dianne Wold’s comments on storyboards (Number 1-9) persuasive and that Armando will rewrite the section moving deferred storyboards to the bottom and noting them as deferred. Motion was seconded by Ed Helton.For 4, against 0, abstain 0 (B. Brown and J. Kiser left room)Motion by Mead, Seconded by Ed Helton that Dianne’s comment on a typo (number 10) is persuasive and should be corrected and Negative Minor (number 11) is persuasive and the paragraph be deleted. For 4, against 0, abstain 0(B. Brown and J. Kiser left room)Motion Mead, Seconded by Armando that comment number 1 from Bill Friggle is non-persuasive, since the Notification had accurately described what was being balloted and that the ballot material was the full standard.. For 6, against 0, against 0Looking at comments for storyboards 3 and 4 are persuasive and should be deleted or deferred since Firebird does not exist. Motion by Mead, second by ArmandoFor 6, against 0, against 0

II. aECGr2 updateBarry Brown provided the following update. No changes need to be made to the model presented and utilize a feature called controlled variables. The vocabulary for the model is managed by the IEEE group and will update vocabulary. The plan going forward will be:Update IG and ballot in SeptemberUpdate Vocabulary through IEEEUpdate the standard to utilize data types R2B.

The PSS was revised to include the implementation guide and submitted to the DESD. See attached.

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Motion by Barry, seconded by Mead to approved the PSS as amended. For 6, against 0, against 0

Wednesday Q2 BRIDG, Business Meeting and continuation of Study Participation Attendees-In personFirst Name Last Name Affiliation E-mail AddressCrystal Allard FDA [email protected] Finseth Medtronic [email protected] Glover Bluewave [email protected] Helton NCI [email protected] James Blue Wave Informatics [email protected] Kiser Abbvie [email protected] Oliva FDA [email protected] Reeves NCTCB [email protected] Smithies NPROGRAM Ltd [email protected] Tripp Edward S. Tripp and Associates [email protected] Walker Mead Walker Consulting [email protected]

I. Business MeetingWe will send out a notice for two special teleconferences on RPS to the listserv to determine availability and interest. There are no other requests to change teleconferences.Julie raised a concern that vocabulary is not being well managed in this domain and that the Thursday vocabulary call has very little discussion with respect to HL7. RCRIM should review who the vocabulary facilitator is. Current listing is Margaret Haber. Margaret no longer attends HL7 meetings. RCRIM needs to establish a Vocabulary Facilitator.Tentative schedule for September WGM

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Day Date Qtr Time Event Session Leader Room

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Monday 23-Sept Q1 9:00-

10:30 TBD

Q2 11:00-12:30 TBD

Q3 1:45 -3:00 TBDQ4 3:30 -5:00 RPS Normative Ballot Reconciliation

Tuesday 24-Sept Q1 9:00-

10:30 aEGG ballot reconciliation (standard and IG)

Q2 11:00-12:30 RPS IG ballot Reconciliation

Q3 1:45 -3:00 NoneQ4 3:30 -5:00 None

Wednesday 25-Sept Q1 9:00-

10:30 SPL r5 Normative Ballot reconciliation

Q2 11:00-12:30

Business MeetingBRIDG Update

Q3 1:45 -3:00 Joint with CIC – Ballot Reconciliation Schizophrenia and Major Depressive Disorder CIC Hosting

Q4 3:30 -5:00 Joint with CIC – Ballot Reconciliation Schizophrenia and Major Depressive Disorder CIC Hosting

Thursday 26-Sept Q1 9:00-

10:30 TBD

Q2 11:00-12:30 TBD

Q3 1:45 -3:00 TBD

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Q4 3:30 -5:00 TBD

RPS Reconciliation, RPS IG ballot Reconciliation, aEGG ballot (IG Standard and/or both), SPL r5 Normative Ballot reconciliation; Business meeting and BRIDG Update. Joint with CIC Q3 and Q4 Wed CIC Hosting.

II. BRIDG Update Ed Helton and Dianne ReevesFrom Nov 2010 through Nov 2011, Ed Helton ran a Clinical Trials management system (CTMS) and that included involvement with BRIDG. Ed has recently asked to manage CTMS once again. There are three relevant contracts; BRIDG Modeling Contract; the BRIDG Panel (previously the BRIDG board) and the BRIDG SME contracts have been placed under FFRDC. Within NCI the Life Science Model (LS Model) will be harmonized with BRIDG. It is unclear if there is a governance structure to go for non NCI organizations. HL7 has a need to harmonize a messages and models with BRIDG. There is a project scope statement for the BRIDG as a DAM project that Ed Tripp will forward to Ed Helton and Dianne Reeves.Per Armando, there is currently a need to harmonize Study Design (about 80% is already harmonized) but RCRIM does not know how to get the work done.Version 3.2 of BRIDG is being loaded with CADSR. There is an appreciable amount of new content that will be available through the registry.

III. Study ParticipationMotion to to address comments 9-15 from Bill Friggle as persuasive with modification and add to the stability statement which states which storyboard features were tested during DSTU. Mead made the motion Ed Helton seconded.For 10, against 0 Abstain 0To address the Major negatives, the motion is that Mead will try to match the name on the Shadow to the element it is shadowing noting it as persuasive. Motion made by Mead, seconded by Rik SmithiesFor 10, against 0 Abstain 0For comment 20 the motion is to consider it non persuasive because the value sets are described in the implementation guide. Motion by Mead, seconded by Ed Helton.

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For 10, against 0 Abstain 0

Wednesday Q3 Joint meeting with CIC (CIC Hosting) – Schizophrenia and Major Depressive Disorder w/RCRIMSee CIC Minutes for attendance and meeting minutes

Wednesday Q4 Joint meeting with CIC (CIC Hosting) – Schizophrenia and Major Depressive Disorder w/RCRIMSee CIC Minutes for attendance and meeting minutes

End of Document

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