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HL7 RCRIM Working Group Meeting MinutesMay 16, 2012
Wednesday Q1 Information mapping and gap/impact analysis for clinical process
Tuesday Q1 Study Design Ballot Reconciliation
AttendeesFirst Name Last Name Affiliation E-mail AddressBecky Angeles ScenPro bangeles@scenpro.comKathleenNicholas
HalseyConnor
European Medicines AgencyMicrosoft
Nick.Halsey@ema.europa.eu kathlee n.connor@microsoft.com
Smita Hastak Scenpro shastak@scenpro.comEd Helton NCI heltone2@mail.nih.govJoyceJohn KiserHernan
dezAbbott LaboratoriesMerck
john.kiser@abbott.com joyce.hernan dez@merck.com
Linda King Eli Lilly & Company king_linda_s@lilly.comWayne Kubick CDISC wkubick@cdisc.orgScottShy MossKumar EpicDatafarm smoss@epic.com shy@datafarminc.
comArmandoRebecca
OlivaKush FDACDISC armando.oliva@fda.hhs.govrkush@cdisc.org
Jean Outeau GPI jean.outeau@gpinformatics.comLise Stevens FDA lise.stevens-Hawkins@fda.hhs.govEd Tripp Edward S. Tripp and
Associatesedward.tripp@estripp.com
Steve Ward Lilly stw@lilly.comVivienne Zhu Regenstrief Institute,
Inc.jzhu@regenstrief.org
I. Information mapping and gap/impact analysis for clinical processEd TrippMead Walker
FHIR: the initial effort will be developing resources to support certain areas, such as Patient Administration. RCRIM projects would likely be low priority at the moment for incorporation into FHIR given the relatively low volume of data. Information Mapping and Gap Analysis for Clinical Research: RCRIM has been asked to look at the clinical research domain and identify where there are gaps in data exchange standards.
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Michael Brennan created a mind map. Wayne created a data flow diagram. Smita suggested looking at the use cases developed for BRIDG business architecture for clinical trials (from planning to conduct, to analysis/reporting. We want to identify the touch points for data exchange, and what standards support those exchanges.was agreement to take a process map approach:
1. What processes occur in clinical research? 2. What actors are involved in those processes? 3. Where/when does data exchange occur? 4. What data are exchanged? 5. What standards support those exchanges? 6. Are the standards adequate? 7. Where are there gaps?
Smita went through the NCI Business Architecture Model (BAM), and the WG applied the above approach to each one. Not all processes were discussed. The discussion will continue Wed Q3.
business architecture model is a top down approach to build a framework for the domain of clinical research and lay out the processes on how to identify and capture all the business use cases in a consistent manner.
https://wiki.nci.nih.gov/display/BAM/Business+Architecture+Model+FilesThere was a high level overview of the BAM during the meeting and then the group drilled down and reviewed the detailed use cases from Initiate Study set. Following are updates made to some of the use cases
Plan Study > Develop Scientific Concept > Develop Scientific Preliminary PlanLook into adding a new use case under this – Define optimized feasibility (needs further discussion)
Initiate Study > Activate Study at Coordinating Center> Distribute Protocol and Associated Materials
Use case includes activities for the Coordinating Center to distribute the approved protocol and associated materials to the participating sites. Materials may include case report forms, study subject calendar template, and a regulatory binder.
NOTE: This is the last step to be completed before study is activated at the Coordinating Center. All other use cases must be completed before this can occur.
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Additional activities that could happen here as follows: (these are potential next level of use cases) NOTE: Clinical Research process content profile in IHE Informing EHR of a constrained version of the study design to allow
study recruitment billing req for compliance (to review charges in context of a study is
useful) scheduling/appt/ordering
Potential stakeholders who we may want to get input from: EHR, RCRIM, Patient Care WG.
ActorsStudy Protocol Coordinator
Add use cases to support the IND approval process – needs to happen before Study can be initiated.
Wednesday Q2 Business Meeting
Smita Hastak Scenpro shastak@scenpro.comArmando Oliva FDA armando.oliva@fda.hhs.govPhil Pochon Covance Phil.Pochon@covance.comEd Tripp Edward S. Tripp and Associates edward.tripp@estripp.comMead Walker Mead Walker Consulting dmead@comcast.netSteve Ward Lilly stw@lilly.comFred Miller Regulatory Informatics Consult. fred@regisfocon.comBehnaz 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%
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Quorum 88.24%Approval 24
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 stated 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.
There were objections by several in attendance to the notion that gaps were adequately defined. It was noted that there were many gaps identified by the BRIDG SCC that it does not address
Wayne: Since Jean-Henri's mapping document was sent out the day before the ballot closed, there was not enough time allowed to adequately review this in the ballot period. What's more, many ballot votes were conducted before this was made available. In my opinion, this should have been part of the ballot package for the full ballot cycle.
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
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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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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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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.com
Elaine 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 CDSI wkubick@cdisc.orgFumika 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
II. Conference Calls Ed TrippThe team discussed the conference call list. The revised list is below:
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Revised CallsCall Name/Listserv Name: Date/Recurrence: Time: SPL - Technical Call Every 2 weeks from May 21, 2012 Monday 2:00PM ET eStability Every week from May 21, 2012 Monday 3:00PM ETRPS workgroup Call Every 2 weeks from May 22, 2012 Tuesday 7:30AM ET RCRIM Work Group Teleconference Every 2 weeks from May 22, 2012 Tuesday 10:00AM ET RPS2r - Testing Team Every week from June 12, 2012 Tuesday 4:00PM CDISC Content to Message - Stage 2 Every 2 weeks from May 23, 2012 Wednesday 11:00AM ET RCRIM Vocabulary Every 2 weeks from May 24, 2012 Thursdays 11:00AM ET Clinical Trials Registration and Results (CTR&R)
Every 2 weeks from May 30, 2012 Wednesday 11:00AM ET
Medical Product Information (SPLr5) Every 2 weeks from Jan 26, 2012 - May 17, 2012
Thursday 10:30AM ET
BRIDG Domain Analysis Model Every month from June 25, 2012 Monday 1:00PM
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III. Project Updates Variousd) RPSr2DSTU Expires Aug 25, 2012 – Need publication requestRPS is awaiting the draft ICH IG. Meeting in Japan week of June 2, 2012. Document will be released for review at that time. Steering Committee meeting at ICH will discuss potential to ballot at HL7. If not balloted at HL7, will there be a regional IG balloted at HL7? There is a need to provide one balloted IG for a v3 message.The team is in process of submitting Publication request of the recently balloted material. There are 8 harmonization proposals for RPS. These need to be finalized, approved by RCRIM and brought to July harmonization meeting.e) CDA® Release 2: Exchange of Clinical Trial Subject Data; Patient NarrativesNeed ballot reconciliation finalized
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Armando reported that all the comments have been addressed and the IG updated. Need to approve reconciliation and post before generating a publication request.f) Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM)
I. Need Ballot Study Design Mead WalkerReconciliation finalizedThere are outstanding ballot comments to resolve. There is a resource lined up to make the changes. Need to especially define the changes. Schedule or plan for executing this will be developed.g) BRIDG as a DAMNeed Publication request.Need an updated PSS.h) Smita will update PSS and bring forward to the RCRIM Working Group. Smita will prepare a publication
request.continuedBallot had a number of comments relative to making the specification backward compatible. Need to bring the issue to M&M and IM1. .Need to provide a standard process for editors to submit controlled MIF files into the ballot and edition process,
not just models.2. The tools should disable all modifications to those supplied MIF files, no renaming, no re-sorting.3. Solidify the status of the combined R1/R2 data type schema that InM had decided to put together (Grahame Grieve). This schema and its application needs an official status and a place on the normative edition (with nod to Lise) so that it can be reliably invoked either optionally or by default.all negatives could be addressed. See consolidate spreadsheet with disposition comments below:
Next WGM Agenda Ed Tripp
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II. PSUR Nick HalseyNick presented the following information on PSUR EU Process.
Tuesday Q3 PSUR – Joint Session with Patient Safetyagenda for the Sept WGM in Baltimore was discussed with the proposed agenda noted below.
Day Date Qtr Time Event Session Leader Room
Monday 10-Sept Q1 9:00-10:30Q2 11:00-12:30Q3 1:45 -3:00Q4 3:30 -5:00
Tuesday 11-Sept Q1 9:00-10:30 RPS update and IG status
Q2 11:00-12:30 Joint with PS PSUR
Q3 1:45 -3:00 BRIDG UpdateJANUS Update
Q4 3:30 -5:00 Study Design
Wednesday 12-Sept Q1 9:00-10:30 ½ SPL½ use of CDA for subject data
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Day Date Qtr Time Event Session Leader Room
Q2 11:00-12:30 Business MeetingUpdate three year plan (use FHIR perspective)
Q3 1:45 -3:00 CT&R test results and ballot preparation
Q4 3:30 -5:00 Lab message (v2) and CG?
Thursday 13-Sept Q1 9:00-10:30 Meet with CIC on Schizophrenia (Check with CIC on time for joint meeting)
Q2 11:00-12:30 Unfinished business.
Q3 1:45 -3:00Q4 3:30 -5:00
A suggestion was made to poll membership on objectives to be accomplished at the Baltimore WGM.
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Wednesday Q3 CTR&R UpdateFirst Name Last Name Affiliation E-mail AddressBecky Angeles ScenPro bangeles@scenpro.comSmitaWilliam HastakGregory ScenproPfizer shastak@scenpro.com gregow@pfizer.com
Margaret Haber NCI mhaber@mail.nih.govEd Helton NCI heltone2@mail.nih.govJohn Kiser Abbott Laboratories john.kiser@abbott.comFredArmando OlivaMiller FDARegulatory Informatics
Consult. armando.oliva@fda.hhs.gov fred@regisfocon.com
Abdul Malik Shakir Shakir Consulting ashakir@shakirconsulting.comMukesh Sharma Washinton University in St.Louis sharmam@wash.eduEd Tripp Edward S. Tripp and Associates edward.tripp@estripp.comSteve Ward Lilly stw@lilly.comNat Wong HL7 Australia nwong@totslcare.net.auJulia Zhang Genzyme Julia.Zhang@genzyme.com
III. CTR&R Update Abdul-Malik ShakirAbdul-Malik Shakir presented the following:
Intent is to re-ballot in January 2013 as a normative message. Also ballot the revised DAM as a DSTU and ballot the IG as an informative document.CTR&R r2 to address results reporting will kick off as of Jan 2013 as the ballots are being reconciled. I may make sense to develop CTR&R r2 within the FHIR methodology.
Wednesday Q4 Information mapping and gap/impact analysis for clinical process-ContinuedBecky Angeles ScenPro bangeles@scenpro.comSmita Hastak Scenpro shastak@scenpro.comEd Helton NCI heltone2@mail.nih.govBehnaz Minaei FDA/CDRH behnaz.minaei@fda.hhs.govScottShree MossNath EpicPointcross Life Sciences smoss@epic.com shree@pointcross.com
Tomoko Okudaira PMDA okudaira_tomoko@pmda.go.jpArmando Oliva FDA armando.oliva@fda.hhs.gov
Shohko 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.com
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Julia Zhang Genzyme Julia.Zhang@genzyme.com
IV. Information mapping and gap/impact analysis for clinical process-continued Ed Tripp
Mead WalkerVivienne Zhu Regenstrief Institute, Inc. jzhu@regenstrief.org
I. PSUR - Continued Mead WalkerThe team continuedworkgroup wants to work determine if BRIDG can be used for a DAM or as a start of a DAM.Nick walked the group through the BAM and identified the following points for information exchangehis high level model.This is the link where you can access the NCI Business Architecture model file -- you can download the EAP file as well as the html version.
https://wiki.nci.nih.gov/display/BAM/Business+Architecture+Model+Files
Becky and Smita, Steve (or Michael), Scott Moss, Mead Walker,, Julia Zang and Ed 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.govBehnaz 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
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I. SPLoff line 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% 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 report to RCRIM7 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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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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