HL7 RCRIM Working Group Meeting Minutes · Web view2012/05/17 · Aff. Neg. Abst. NV Affiliate 0 0...

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 [email protected]

HalseyConnor

European Medicines AgencyMicrosoft

[email protected] kathlee [email protected]

Smita Hastak Scenpro [email protected] Helton NCI [email protected] KiserHernan

dezAbbott LaboratoriesMerck

[email protected] joyce.hernan [email protected]

Linda King Eli Lilly & Company [email protected] Kubick CDISC [email protected] MossKumar EpicDatafarm [email protected] shy@datafarminc.

comArmandoRebecca

OlivaKush FDACDISC [email protected]@cdisc.org

Jean Outeau GPI [email protected] Stevens FDA [email protected] Tripp Edward S. Tripp and

[email protected]

Steve Ward Lilly [email protected] Zhu Regenstrief Institute,

[email protected]

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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mailto:[email protected]















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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https://wiki.nci.nih.gov/display/BAM/Business+Architecture+Model+Files


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 [email protected] Oliva FDA [email protected] Pochon Covance [email protected] Tripp Edward S. Tripp and Associates [email protected] Walker Mead Walker Consulting [email protected] Ward Lilly [email protected] Miller Regulatory Informatics Consult. [email protected] Minaei FDA/CDRH [email protected] Outeau GPI [email protected]

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 [email protected]

Elaine Ayres NIH Clinical Center [email protected] Gregory Pfizer [email protected] Halsey European Medicines Agency [email protected] Hernandez Merck [email protected] Kiser Abbott Laboratories [email protected] Kubick CDSI [email protected] Kubota PMDA [email protected] Kush CDISC [email protected] Miller Regulatory Informatics Consult. [email protected] Minaei FDA/CDRH [email protected] Moss EPIC [email protected] Oliva FDA [email protected] Pochon Covance [email protected] Sekine Pharmaceuticals & Medical Devices [email protected] Smithies NPROGRAM Ltd [email protected] Tripp Edward S. Tripp and Associates [email protected] Walker Mead Walker Consulting [email protected] Ward Lilly [email protected] Wong HL7 Australia [email protected] Zhang Genzyme [email protected]

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 [email protected] HastakGregory ScenproPfizer [email protected] [email protected]

Margaret Haber NCI [email protected] Helton NCI [email protected] Kiser Abbott Laboratories [email protected] OlivaMiller FDARegulatory Informatics

Consult. [email protected] [email protected]

Abdul Malik Shakir Shakir Consulting [email protected] Sharma Washinton University in St.Louis [email protected] Tripp Edward S. Tripp and Associates [email protected] Ward Lilly [email protected] Wong HL7 Australia [email protected] Zhang Genzyme [email protected]

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 [email protected] Hastak Scenpro [email protected] Helton NCI [email protected] Minaei FDA/CDRH [email protected] MossNath EpicPointcross Life Sciences [email protected] [email protected]

Tomoko Okudaira PMDA [email protected] Oliva FDA [email protected]

Shohko Sekine PMDA [email protected] Sperzel Apelon, Inc [email protected] Tripp Edward S. Tripp and Associates [email protected] Walker Mead Walker Consulting [email protected] Ward Lilly [email protected]

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mailto:%[email protected]





Julia Zhang Genzyme [email protected]

IV. Information mapping and gap/impact analysis for clinical process-continued Ed Tripp

Mead WalkerVivienne Zhu Regenstrief Institute, Inc. [email protected]

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.


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 [email protected]

William Gregory Pfizer [email protected]

Ed Helton NCI [email protected] Minaei FDA/CDRH [email protected]

Armando Oliva FDA [email protected]

David Sperzel Apelon, Inc [email protected]

Marti Velezis Sonrisa Consulting [email protected]

Steve Ward Lilly [email protected]

Julia Zhang Genzyme [email protected]

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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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HL7 RCRIM Working Group Meeting Minutes · Web view2012/05/17 · Aff. Neg. Abst. NV Affiliate 0 0...

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