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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
Tuesday Q1 Study Design Ballot Reconciliation
AttendeesFirst Name Last Name Affiliation E-mail AddressBecky Angeles ScenPro bangeles@scenpro.comKathleen Connor Microsoft kathleen.connor@microsoft.comSmita Hastak Scenpro shastak@scenpro.comEd Helton NCI heltone2@mail.nih.govJoyce Hernandez Merck joyce.hernandez@merck.comLinda King Eli Lilly & Company king_linda_s@lilly.comShy Kumar Datafarm shy@datafarminc.comRebecca Kush CDISC rkush@cdisc.orgArmando Oliva FDA armando.oliva@fda.hhs.govPhil Pochon Covance Phil.Pochon@covance.comEd Tripp Edward S. Tripp and
Associatesedward.tripp@estripp.com
Mead Walker Mead Walker Consulting
dmead@comcast.net
Steve Ward Lilly stw@lilly.comFred Miller Regulatory
Informatics Consult. fred@regisfocon.com
Behnaz Minaei FDA/CDRH behnaz.minaei@fda.hhs.govJean Outeau GPI jean.outeau@gpinformatics.com
I. Study Design Ballot Reconciliation Mead WalkerThe summary of the balloting is in the table below.
Aff. Neg. Abst. NVAffiliate 0 0 14 2Consultant 0 1 3 2Government/Non-Profit 10 2 2 1Payor 0 0 0 0Pharmaceutical 3 12 0 2Provider 11 0 20 4Vendor 1 0 11 1Totals 25 15 50 12% of Votes 24.51% 14.71% 49.02% 11.76%Quorum 88.24%Approval 24
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.
The spreadsheet below is a consolidation of all comments uploaded via spreadsheet.
One Major Negative comment was discussed: study design not harmonized with BRIDG.
The expressed concern is that the study design model in BRIDG is not semantically equivalent to Study Design Structured Document that was created and balloted. A better approach would have been to start with BRIDG to design the RMIM, however this is not what the approved project scope statement had proposed. It started with the Study Design message, which is mostly in BRIDG.
Mead: FDA has provided a preliminary mapping to BRIDG. Although it was not part of the ballot, it was provided as a reference to the ballot. Jean-Henri performed the mapping as part of the Clinical Trials Repository (CTR) project, and he confirms that it adequately identifies the gaps. He also mentions that it doesn’t make sense to fully map this artifact to BRIDG; it makes more sense to harmonize a constrained implementation guide. The project did what it was supposed to do, according the scope statement. Armando noted that the HL7 BRIDG Harmonization Process and Procedures document does not require BRIDG harmonization before the ballot. FDA has a concern that forcing harmonization before ballot will unacceptably slow down projects since BRIDG harmonization is not under the project team’s direct control.
The group recognizes the benefits of harmonizing first with BRIDG and using BRIDG to define the RMIM. However, how do we move forward and not lose the work that has been performed to date?
The agreed resolution is to start with the existing BRIDG mapping document, update it as needed, and use that as the basis for conducting a BRIDG harmonization within the SCC, which will likely take a matter of weeks. This will be included in the DSTU package that gets published.
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
The text document below was submitted by Joyce Hernandez.
Comments from Joyce:a) Can I use the path of TimePointEventCharacteristics to
TimpointEventDefinition to define an activity occurring at the study level?
No you cannot use this path to define this activity, however there is another path in the model. There is an association between PlannedStudy and PlannedStudyActivity (component 3)
b) Should we had a priorityNumber that can be used to override the normal sequence of activitites given certain conditions?
We can and will consider.
c) ARM needs a code variable. The CDISC model contains both an ARM and ARMCD variables. We don't want to lose data we we transform from one format to another.
Yes we should add a code variable.
d) Have we addressed the overlapped between SD and SP. Can we define cohortgroups combinations in SD and reference them in SP?
There is no guidance that explains the overlap. We will look to Stage II group to address.Yes. The SD message provides for groups.
e) Some miscellaneous questions:a) Did we make repeatNumber optional? Not many activities repeat
during a visit.Yesb) Can I use TimepointEventCharacteristic to link one or more activities in
a visit?Need to discuss with Stage II group.c) Where is the link to the protocol (human readable) document? The
human readable dpcument weill contain narratives which have not been broken down into the XML tagged entries.
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
The top level class has a text attribute that allows for insertion of an entire document and there are text sections that allow insertion or creation of text for these sections. Also can have a non XML body.
Tuesday Q2 Joint session with Patient SafetyFirst Name Last Name Affiliation E-mail AddressBecky Angeles ScenPro bangeles@scenpro.comElaine Ayres NIH Clinical Center eayres@nih.govWilliam Gregory Pfizer gregow@pfizer.comNicholas Halsey European Medicines Agency Nick.Halsey@ema.europa.euJoyce Hernandez Merck joyce.hernandez@merck.comJohn Kiser Abbott Laboratories john.kiser@abbott.comWayne Kubick Phase Forward wayne.kubick@phaseforward.comFumika Kubota PMDA kubota-fumika@pmda.go.jpRebecca Kush CDISC rkush@cdisc.orgFred Miller Regulatory Informatics Consult. fred@regisfocon.comBehnaz Minaei FDA/CDRH behnaz.minaei@fda.hhs.govScott Moss EPIC smoss@epic.comArmando Oliva FDA armando.oliva@fda.hhs.govPhil Pochon Covance Phil.Pochon@covance.comShonko Sekine Pharmaceuticals & Medical Devices sekine-shoko@pmda.go.jpRik Smithies NPROGRAM Ltd rik@nprogram.co.ukEd Tripp Edward S. Tripp and Associates edward.tripp@estripp.comMead Walker Mead Walker Consulting dmead@comcast.netSteve Ward Lilly stw@lilly.comNat Wong HL7 Australia nwong@totalcare.net.auJulia Zhang Genzyme Julia.Zhang@genzyme.com
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
I. Study Design Mead WalkerReconciliation continued so that all negatives could be addressed. See consolidate spreadsheet with disposition comments below:
II. PSUR Nick HalseyNick presented the following information on PSUR EU Process.
Tuesday Q3 PSUR – Joint Session with Patient SafetyFirst Name Last Name Affiliation E-mail AddressBecky Angeles ScenPro bangeles@scenpro.comWilliam Gregory Pfizer gregow@pfizer.comMargaret Haber NCI mhaber@mail.nih.govEd Helton NCI heltone2@mail.nih.govJohn Kiser Abbott Laboratories john.kiser@abbott.comFred Miller Regulatory Informatics Consult. fred@regisfocon.comBehnaz Minaei FDA/CDRH behnaz.minaei@fda.hhs.govShree Nath Pointcross Life Sciences shree@pointcross.comTomoko Okudaira PMDA okudaira_tomoko@pmda.go.jpArmando Oliva FDA armando.oliva@fda.hhs.govShohko Sekine PMDA sekine.shohko@pmda.go.jpDavid Sperzel Apelon, Inc dsperzel@apelon.comEd Tripp Edward S. Tripp and Associates edward.tripp@estripp.comMead Walker Mead Walker Consulting dmead@comcast.netSteve Ward Lilly stw@lilly.comJulia Zhang Genzyme Julia.Zhang@genzyme.comVivienne Zhu Regenstrief Institute, Inc. jzhu@regenstrief.org
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
I. PSUR - Continued Mead WalkerThe workgroup wants to determine if BRIDG can be used for a DAM or as a start of a DAM.Nick walked the group through his high level model.
Becky and Smita reviewed the BRIDG Adverse Event subdomain, to identify if there is potential for use to expedite DAM development.
Patient Safety will consider hosting work sessions (on Wednesdays) with RCRIM members invited. Updates and announcement of work sessions will occur at the Tuesday RCRIM teleconference.
Tuesday Q4 SPL Ballot ReconciliationFirst Name Last Name Affiliation E-mail AddressLee Coller Oracle lee.coller@oracle.com
William Gregory Pfizer gregow@pfizer.com
Ed Helton NCI heltone2@mail.nih.gov
Behnaz Minaei FDA/CDRH behnaz.minaei@fda.hhs.gov
Armando Oliva FDA armando.oliva@fda.hhs.gov
David Sperzel Apelon, Inc dsperzel@apelon.com
Marti Velezis Sonrisa Consulting marti.velezis@sonrisaconsulting.com
Steve Ward Lilly stw@lilly.com
Julia Zhang Genzyme Julia.Zhang@genzyme.com
I. SPL Ballot Reconciliation TBDThe summary of the balloting is in the table below.
Aff. Neg. Abst. NVAffiliate 0 0 24 1Consultant 2 1 1 1Government/Non-Profit 3 9 1 1Payor 0 0 0 0Pharmaceutical 1 6 0 3Provider 14 0 15 4Vendor 0 3 14 3Totals 20 19 55 13
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
% of Votes 18.69% 17.76% 51.40% 12.15%Quorum 87.85%Approval 30
The consolidated comments spreadsheet lists all votes cast and comments or reference to the uploaded comment spreadsheet.
The spreadsheet below is a consolidation of all comments uploaded via spreadsheet.
Ballot comment uploaded via Word document:
There were 2 co-chairs and 7 members, one member short of quorum. The ballot reconciliation could not proceed. The principal negative comment is the lack of backwards compatibility between R2 and R1. The proposed solution is an SPL schema that supports both R1 and R2 datatypes. What should a stakeholder do if they wish to use R2 dataypes? The proposed plan is to:
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HL7 RCRIM Working Group Meeting MinutesMay 15, 2012
a) Schedule a joint resolution meeting with the appropriate representatives from the following work groups: InM, MnM, Publication, RCRIM and CPM in the week following the May WGM
Determine what will be supported for backwards compatibility
Determine if both R1 and R2 datatypes will be supported by the solution
Plan for reconciling the supporting materials (e.g., schemas) in the publication materials that are included in the HL7 v3 Normative Edition
b) Debrief back to RCRIM
Add an agenda item to the RCRIM meeting following the joint resolution meeting
Debrief RCRIM WG members on the results of the joint resolution meeting
Determine the next steps for the Ballot Reconciliation - will the negative votes be removed by the recommended resolution or will another ballot cycle be required to bring SPL R5 to a Normative status?
We plan to have a brief meeting tomorrow Q2 to review their plan of action to move this forward.
End of Document
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