RCRIM Off-cycle MeetingRCRIM Off-cycle Meeting

Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs

AgendaAgenda

8:30 Overview of RCRIM work – Randy Levin, Ed Tripp

10:30 BRIDG – Julie Evans, Doug Fridsma 13:30 WHO Clinical Trial Registry – Becky Kush 14:30 Terminology – Bron Kisler, Margaret Haber 15:30 Regulated Product Submission – Jason Rock

Overview of RCRIM WorkOverview of RCRIM Work

Randy Levin, Ed Tripp

HL7 MissionHL7 Mission

"To provide standards for the exchange, management and integration of data that support clinical patient care and the management, delivery and evaluation of healthcare services. Specifically, to create flexible, cost effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems."

Health Level SevenHealth Level Seven

Accredited by the American National Standards Institute (ANSI)

Open, international membership Technical Committees directly responsible for the

content of the Standards; Special Interest Groups explore new areas that may need coverage

Defines messages, document structures, and terminology to support the systems and processes used in the collection, storage, distribution, integration and analysis of research and healthcare information.

GovernanceGovernance

Managed by Board of Directors, comprised of eight elected positions and three appointed positions.

Technical Committees and Special Interest Groups are responsible for defining the content of the Standards. Each Technical Committee and Special Interest group is chaired by two or more co-chairs.

Collectively, co-chairs comprise the Technical Steering Committee, which votes on issues related to the standard. Votes of the Technical Steering Committee are passed as recommendations to BOD, who make final decision.

Well-defined set of operating procedures to ensure openness and balance of interest. Meetings and voting cycles are regularly scheduled and open.

Anyone who is interested can participate and contribute at face-to-face meetings and in scheduled teleconferences but only registered voting members can vote during formal ballot cycles.

Active technical committeesActive technical committees

– Architectural Review Board– Clinical Context Object

Workgroup (CCOW)– Clinical Decision Support– Control/Query– Education (admin)– Electronic Health Records– Electronic Services– Financial Mgmt.– Implementation (admin)– Infrastructure and Messaging– Marketing (admin)– Medical Records/Information

Management

– Modeling & Methodology– Orders/Observations – Patient Administration– Patient Care– Personnel Management– Process Improvement

(admin)– Publishing (admin)– Regulated Clinical Research Regulated Clinical Research

Info Mgmt.Info Mgmt.– Scheduling & Logistics– Security– Structured Documents– Tooling (admin)– Vocabulary.

Special Interest GroupsSpecial Interest Groups

Devices– Health Care Devices– Imaging Integration– Laboratory

Selected therapeutic areas– Cardiology– Emergency Care– Anesthesia– Pediatrics

New frontiers– Clinical Genomics– Patient SafetyPatient Safety– Public Health and

Emergency Response

Other:– Arden Syntax

– Attachments

– Clinical Guidelines

– Community Based Health Services

– Conformance

– Government Projects

– Java

– Pharmacy

– Templates

– XML

The Reference Information Model (RIM)The Reference Information Model (RIM)

Cornerstone of the HL7 Version 3 development process. An object model created as part of the Version 3 methodology, the RIM is a large pictorial representation of the clinical data (domains) and identifies the life cycle of events that a message or groups of related messages will carry.

Shared model across all domains and is the model from which all domains create their messages.

Explicitly represents connections that exist between the information carried in the fields of HL7 messages, essential to enabling interoperability.

RIMRIM

Account

balanceAmt : MOcurrencyCode : CEinterestRateQuantity : RTO<MO,PQ>allow edBalanceQuantity : IVL<MO>

DeviceTask

parameterValue : LIST<ANY>

Diet

energyQuantity : PQcarbohydrateQuantity : PQ

FinancialContract

paymentTermsCode : CE

FinancialTransactionamt : MOcreditExchangeRateQuantity : REALdebitExchangeRateQuantity : REAL

InvoiceElement

modif ierCode : SET<CE>unitQuantity : RTO<PQ,PQ>unitPriceAmt : RTO<MO,PQ>netAmt : MOfactorNumber : REALpointsNumber : REAL

ManagedParticipation

id : SET<II>statusCode : CS

Observation

value : ANYinterpretationCode : SET<CE>methodCode : SET<CE>targetSiteCode : SET<CD>

PatientEncounter

preAdmitTestInd : BLadmissionReferralSourceCode : CElengthOfStayQuantity : PQdischargeDispositionCode : CEspecialCourtesiesCode : SET<CE>specialArrangementCode : SET<CE>

Procedure

methodCode : SET<CE>approachSiteCode : SET<CD>targetSiteCode : SET<CD>

PublicHealthCasedetectionMethodCode : CEtransmissionModeCode : CEdiseaseImportedCode : CE

SubstanceAdministration

routeCode : CEapproachSiteCode : SET<CD>doseQuantity : IVL<PQ>rateQuantity : IVL<PQ>doseCheckQuantity : SET<RTO>maxDoseQuantity : SET<RTO>administrationUnitCode : CEmethodCode : SET<CD>

Supply

quantity : PQexpectedUseTime : IVL<TS>

WorkingList

ow nershipLevelCode : CE

ContainercapacityQuantity : PQheightQuantity : PQdiameterQuantity : PQcapTypeCode : CEseparatorTypeCode : CEbarrierDeltaQuantity : PQbottomDeltaQuantity : PQ

DevicemanufacturerModelName : SCsof tw areName : SClocalRemoteControlStateCode : CE...alertLevelCode : CElastCalibrationTime : TS

LivingSubjectadministrativeGenderCode : CEbirthTime : TSdeceasedInd : BLdeceasedTime : TSmultipleBirthInd : BLmultipleBirthOrderNumber : INTorganDonorInd : BL

ManufacturedMaterial

lotNumberText : STexpirationTime : IVL<TS>stabilityTime : IVL<TS>

MaterialformCode : CE

NonPersonLivingSubject

strainText : EDgenderStatusCode : CE

Organization

addr : BAG<AD>standardIndustryClassCode : CE

Personaddr : BAG<AD>maritalStatusCode : CEeducationLevelCode : CEraceCode : SET<CE>disabilityCode : SET<CE>livingArrangementCode : CEreligiousAf f iliationCode : CEethnicGroupCode : SET<CE>

Place

mobileInd : BLaddr : ADdirectionsText : EDpositionText : EDgpsText : ST

Access

approachSiteCode : CDtargetSiteCode : CDgaugeQuantity : PQ

Employee

jobCode : CEjobTitleName : SCjobClassCode : CEoccupationCode : CEsalaryTypeCode : CEsalaryQuantity : MOhazardExposureText : EDprotectiveEquipmentText : ED

LicensedEntity

recertif icationTime : TS

Patient

veryImportantPersonCode : CE

RIM 2.13Feb. 10, 2006

ControlAct

DiagnosticImage

subjectOrientationCode : CE

LanguageCommunicationlanguageCode : CEmodeCode : CEprof iciencyLevelCode : CEpreferenceInd : BL

EntityclassCode : CSdeterm inerCode : CSid : SET<II>code : CEquantity : SET<PQ>nam e : BAG<EN>desc : EDstatusCode : CSexistenceTim e : IVL<TS>...te lecom : BAG<TEL>riskCode : CEhandlingCode : CE

1

0..n

1

0..n

RoleLink

typeCode : CSpriorityNum ber : INTeffectiveTim e : IVL<TS>...

Role

classCode : CSid : SET<II>code : CEnegationInd : BLnam e : BAG<EN>addr : BAG<AD>te lecom : BAG<TEL>statusCode : CSeffectiveTim e : IVL<TS>certificateText : EDconfidentialityCode : SET<CE>...quantity : RTOpositionNum ber : LIST<INT>...

0..n0..1

playedRole0..n

player

0..1

0..n0..1

scopedRole

0..n

scoper

0..1

0..n

1

outboundLink 0..n

source1

0..n

1

inboundLink

0..n

target1

Participation

typeCode : CSfunctionCode : CDcontextControlCode : CS...sequenceNum ber : INTnegationInd : BLnoteText : EDtim e : IVL<TS>m odeCode : CEaw arenessCode : CEsignatureCode : CEsignatureText : EDperform Ind : BLsubstitutionConditionCode : CE...subsetCode : CS

0..n

1

0..n

1

ActRelationship

typeCode : CSinvers ionInd : BLcontextControlCode : CScontextConductionInd : BLsequenceNum ber : INTpriorityNum ber : INTpauseQuantity : PQcheckpointCode : CSsplitCode : CSjoinCode : CSnegationInd : BLconjunctionCode : CSlocalVariableNam e : STseperatable Ind : BLsubsetCode : CSuncertaintyCode : CE

Act

classCode : CSm oodCode : CSid : SET<II>code : CDnegationInd : BLderivationExpr : STtitle : EDtext : EDstatusCode : CSeffectiveTim e : GTSactivityTim e : GTSavailabilityTim e : TSpriorityCode : SET<CE>confidentialityCode : SET<CE>...repeatNum ber : IVL<INT>interruptible Ind : BLlevelCode : CEindependentInd : BLuncertaintyCode : CEreasonCode : SET<CE>languageCode : CE

0..n

1

0..n

1

0..n

1 inboundRelationship0..ntarget

1

0..n

1

outboundRelationship

0..n

source 1

Qualif iedEntity

equivalenceInd : BL

Ballot TypesBallot Types

Committee Level BallotMembership BallotDraft Standard For Trial UseInformative Ballot

The Ballot ScheduleThe Ballot Schedule

RCRIMRCRIM

Focus is standards that improve or enhance information management during research and regulatory evaluation of the safety and efficacy of therapeutic products or procedures worldwide.

Participation includes FDA and international regulatory agencies, other government agencies (e.g. CDC), PhRMA, CDISC, academic research organizations, biopharmaceutical companies, and vendors and service providers who operate in pharmaceutical market.

Regulated Clinical Research Information Management (RCRIM) Technical Committee

RCRIMRCRIM

Defines messages, document structures, and terminology to support the systems and processes used in the collection, storage, distribution, integration and analysis of clinical research and drug development information.

Interchange structure specifications developed to conform to business requirements and data and information needs of regulatory authorities and pharma industry AND common information model, defined data types, controlled vocabularies, and code lists.

Standards Development and AdoptionStandards Development and Adoption

Research ProcessStandardized

representation of clinical trial protocol

Research Data

Periodic reporting of clinical trial laboratory data*

Annotation of ECGs*

Data for regulatory submission (clinical, non-clinical, pharmacogenomic)

Clinical trial registries

Surveillance Individual Case Safety

Report*

Generic Incident Notification

Regulatory Submissions

Structured product labeling*

Stability data reporting*

Regulated Product Submission

*Approved and recognized as ANSI standard

RCRIM

Standards Available and in UseStandards Available and in Use

Structured Product Label Specifies structure and semantics for the regulatory

requirement and content of product labeling and has been approved as a Clinical Document Architecture (CDA) (based on HL7 RIM) at the membership level and is recognized as an ANSI standard.

FDA Electronic Labeling Rule has been implemented and provides for use of new technologies (e.g. SPL) as available. FDA Physician Labeling Rule requires highlights supported by SPL.

Several vendors have or are developing application that support SPL. FDA has received nearly 1,000 submissions in this format.

Implementation efforts underway to support Physician Labeling Rule (PLR)

RCRIM

Standards Available and in UseStandards Available and in Use

Notifiable Condition ReportFor public health/biosurveillance

reporting

Individual Case Safety Report (ICSR)Meets requirements of ICH E2B.

Electronic replacement for Medwatch

RCRIM

Available and in UseAvailable and in Use

Annotation of ECGs (Annotated ECG waveform standard)

Fully balloted Version 3 RIM message and recognized as ANSI standard; Implementation Guide approved.

FDA has now received thousands of submissions in this format

eStability Data Drug Stability Report (for submitting product

stability data to the FDA) fully balloted as HL7 Version 3 message.

RCRIM

Standards Available and in UseStandards Available and in Use

Periodic Reporting of Clinical Trial Laboratory Data

Based on CDISC LAB Model V1.0; fully balloted Version 3 RIM message and recognized as ANSI standard

Release 2 incorporating PGx data and other extensions in ballot process.

RCRIM

Standards Under DevelopmentStandards Under Development

Structured Clinical Trial Protocol (SCTP) Release 1 (subset of elements) balloted as an HL7 Clinical

Document Architecture (CDA) at the committee level in May 2004 Protocol Representation (PR) Group defining standard elements

and semantics for the content of clinical trial protocols, with goal of creating a machine-readable electronic protocol representation.

Messages for two related use cases under development.– Clinical trial registries

• Project to develop requirements and interchange standards approved September 2004

– eDCI (electronic definition of Data Collection Instrument)• Undertaking to create an HL7 V3 message to convey the definition of an

Data Collection Instrument between applications; Being developed under auspices of NCI as early adopter. Potential for use as instructions to EHR system.

RCRIM

Clinical Trial Registry MessageClinical Trial Registry Message

HL7 message specification for submission of trial information to external clinical trial registries, e.g.ClinicalTrials.gov, EudraCT, PDQ, WHO

Additional Use Cases:– Internal project management tools for

trial/protocol tracking – Regulatory submission

RCRIM

Protocol Representation TimelineProtocol Representation Timeline

Additional Ballot CyclesBallot General Clinical Trial Registry HL7

Message

Draft genCTR Implementation

Guide

BRIDG Modeling:

PR Element Spreadsheet, Trial Design

Develop Clinical Trial Eligibility

Criteria

Update CDISC Glossary and Publish

Annually in ACT

Draft General Clinical Trial Registry HL7

Message

Draft SCTP Implementation

Guide

Finalize genCTR Implementation

Guide

Finalize SCTP Implementation

Guide

Additional Ballot Cycles

20052005 20062006 20072007 20082008 20102010

ANSI Standards

Draft and Ballot ICH SCTP HL7 Message

RCRIM

Standards Under DevelopmentStandards Under Development

Generic Incident Notification (GIN)– To support generic reporting for process

improvement and organizational learning

Regulated Product Submission– Project to define a message that is general

enough to be used broadly for submissions across all regulated products and includes information (metadata) that allows regulators to support structured review

RCRIM

Regulated Product SubmissionRegulated Product Submission

Scope Animal and Human products including but not limited to

food additives, human therapeutics, veterinary products, and medical devices – Same message structure for all product types– Different controlled lists for each product type

Worldwide useOut of Scope Submission contentPlanned for later release Inclusion of information about the submission (e.g.

information currently collected on application forms) Two-way communications.

RCRIM

RPS: Phase 1RPS: Phase 1

Transmission of electronic submissions for a regulated products.

Tagging of submissions for effective review, including, but not limited to allowing creation of a table of contents.

Provides an electronic submission standard to regulated products where no submission standards exist.

Basic requirements: re-use of documents and document components; management of submission lifecycle, submission of form data (different for each regulated product)

Allows applicants to re-use documents that were already submitted. In the case of human therapeutics, standard will allow applicants to move from an IND to a marketing application seamlessly.

RCRIM

Current Ballots From RCRIMCurrent Ballots From RCRIM

HL7 Version 3 Standard: Patient Safety: Generic Incident Notification, Release 1

HL7 Version 3 Standard: Periodic Reporting of Clinical Trial Laboratory Data, Release 2

HL7 Version 3 Standard: Regulated Product Submission, Release 1

All are Draft Standards for Trial Use (DSTU)

AgendaAgenda

8:30 Overview of RCRIM work – Randy Levin, Ed Tripp

10:30 BRIDG – Julie Evans, Doug Fridsma 13:30 WHO Clinical Trial Registry – Becky Kush 14:30 Terminology – Bron Kisler, Margaret Haber 15:30 Regulated Product Submission – Jason Rock