RCRIM Off-cycle Meeting Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs.
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Transcript of RCRIM Off-cycle Meeting Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs.
![Page 1: RCRIM Off-cycle Meeting Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs.](https://reader030.fdocuments.us/reader030/viewer/2022033108/56649ed35503460f94be4062/html5/thumbnails/1.jpg)
RCRIM Off-cycle MeetingRCRIM Off-cycle Meeting
Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs
![Page 2: RCRIM Off-cycle Meeting Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs.](https://reader030.fdocuments.us/reader030/viewer/2022033108/56649ed35503460f94be4062/html5/thumbnails/2.jpg)
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
![Page 3: RCRIM Off-cycle Meeting Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs.](https://reader030.fdocuments.us/reader030/viewer/2022033108/56649ed35503460f94be4062/html5/thumbnails/3.jpg)
Overview of RCRIM WorkOverview of RCRIM Work
Randy Levin, Ed Tripp
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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."
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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.
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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.
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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.
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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
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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.
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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
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Ballot TypesBallot Types
Committee Level BallotMembership BallotDraft Standard For Trial UseInformative Ballot
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The Ballot ScheduleThe Ballot Schedule
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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