HL7 Version 3 Laboratory Result-based Adverse Event Assessment Message Specifications RCRIM Technical Meeting September 18, 2007 Jennifer Neat Project.

HL7 Version 3 Laboratory Result-based

Adverse Event Assessment Message Specifications

RCRIM Technical MeetingSeptember 18, 2007

Jennifer NeatProject Leader, City of Hope

Abdul Malik ShakirHL7 Facilitator, Shakir Consulting

September 18, 2007 HL7 V3 Lab-Based Adverse Event Assessment Message Specification 2 of 22

Introduction

Project Scope

Develop an HL7 v3 draft standard for trial use messaging specification that supports the unique data requirements for initial laboratory

result-based adverse event (AE) assessment information.

Objectives Met

Evaluated existing message structures and identified the HL7 v3 CT Laboratory Message DSTU as an appropriate structure for laboratory result-based AE assessment messaging specifications

Defined an AE Assessment CMET as an optional structure within the revised CT Laboratory Message

Identified the AE Assessment CMET vocabulary requirements

Identified the required messaging interactions


Regulated Studies Domain

sd Summary of CT Interactions in Regulated Studies Domain

REG AGENCYSUBMISSION SYS

CT SPONSOR/AGENT DATA MANAGEMENTSYSTEM

CLINICAL TRIAL LAB SYSTEMECG ANALYSIS SYSTEMSTUDY SITE STUDY TRACKINGSYSTEM

ObservationOrder GlobalPlacer - CT

ObservationEvent GlobalTracker - CT

ECG AnnotationOrder GlobalFulfil ler - CT

ECG AnnotationEvent GlobalInformer - CT

Lab ObservationOrder GlobalFulfil ler - CT

Lab ObservationEvent GlobalInformer - CT



ObservationEvent GlobalInformer - CT


AnnotatedECG(Rev ised,Notification)

AnnotatedECGSubmittable,Notification

AnnotatedECG(Deleted,Notification)

"manual" transmission of ECG material to beanalyzed w/ appropriate identification (no HL7msg type yet defined)

"manual" tranmission of ECG material to be analyzed w/appropriate identification (no HL7 msg type yet defined)

"manual" tranmission of lab material to be analyzed w/appropriate identification (no HL7 msg type yet defined)

CTLaboratoryPeriodic Reportto Sponsor/Agent

CTLaboratory Report to Study Site (no HL7 msgtype yet defined)

Summary of Clinical Trial Interactions in the Regulated Studies Domain


sd Summary of CT Interactions in Regulated Studies Domain_Rev ised

LABORATORY RESULT-BASED ADVERSE EVENTASSESSMENT INTERACTION SCOPE

STUDY SITE STUDY TRACKINGSYSTEM

AE ASSESSMENTSERVICE

ECG ANALYSIS SYSTEM CLINICAL TRIAL LAB SYSTEM CT SPONSOR/AGENT DATA MGMT SYSEM REG AGENCYSUBMISSION SYS

ECG AnnotationEvent GlobalInformer - CT

ECG AnnotationOrder GlobalFulfi l ler - CT

Lab ObservationEvent GlobalInformer - CT

Lab ObservationOrder GlobalFulfi l ler - CT

Adverse EventAssessment

Observation Fulfi l ler

ObservationEvent GlobalInformer - CT






Annotated ECG(Revised, Notfication)

Annotated ECGSubmittable,NotificationAnnotated ECG (Deleted,

Notification)

manual transmission of ECG material to be analyzed w/appropriate identification (no HL7 msg type yet defined)

manual transmission of ECG material to be analyzed w/ appropriateidentification (no HL7 msg type yet defined)

manual transmission of lab material to be analyzed w/ appropriateidentification (no HL7 msg type yet defined) CTLaboratory

Periodic Reportto Sponsor/Agent

CTLaboratory Report to Study Site(no HL7 msg type yet defined)

CT Laboratory Results Adv erseEv ent Assessment Request

CT LaboratoryAdv erse Ev entAssessmentResponse

Project Scope in ContextRevised Summary Clinical Trial Interactions to include:AE Assessment Request AE Assessment Response


Storyboard Overview

Laboratory test results can indicate a patient has experienced/is experiencing an adverse event (AE).

For clinical trials mandating use of a grading criteria for assessing laboratory result-based AEs, laboratory test results may be transmitted to an automated AE assessment service.

The AE assessment service evaluates the laboratory results subject to quantitative AE assessment, based on the specified grading criteria, such as the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE).

An initial / first-level assessment is performed to determine the presence and severity of an AE(s).

Upon completion, the laboratory test results and associated AE assessment outcomes are transmitted to a clinical information system within the clinical research environment.

Subsequent investigation into the patient’s condition must be conducted within the clinical research environment in order to determine, in part, the AE reporting requirements.


Storyboard

CT Laboratory Result-based Adverse Event Assessment (PORT_SN03000x)

Narrative

A laboratory facility has performed one or more tests on a patient specimen and the results of the testing are available electronically for review and further evaluation within the clinical research environment.

A request is sent to an automated AE assessment service to evaluate the laboratory test results.

Each test result that is subject to quantitative AE assessment is evaluated for the presence and severity of an adverse event, and the test result is appended with this AE assessment outcome data.

The AE assessment service sends a response message containing the original and appended information.


Interaction Diagramsd CT Laboratory Results AE Assessment

AE ASSESSMENTSERVICE

STUDY SITE STUDY TRACKING SYSTEM /CLINICAL INFORMATION SYSTEM

Observation OrderGlobal Placer -

CT

Observation EventGlobal Tracker -

CT

Adverse EventAssessment

Observation Fulfi l ler

CT Laboratory Results AdverseEvent Assessment Request

CT Laboratory ResultsAdverse Event AssessmentResponse

Purpose

The storyboard demonstrates an initial / first-level

evaluation of clinical trial laboratory results subject to quantitative

adverse event assessment.


Interaction Design Elements & Descriptions: Application Roles

ClinicalTrial Observation Order Global Placer(PORT_AR03000x)

An application that is capable of notifying another application about a significant clinical trial observation event and expects the receiver to take action.

Adverse Event Assessment Observation Fulfiller(PORT_AR03000y)

An application that is capable of receiving an adverse event (AE) assessment request from a Placer application. The Adverse Event Assessment Observation Fulfiller is responsible for evaluating clinical trial laboratory results and deriving AE assessment outcome data. The fulfiller is also responsible for initiating communication of this data to the Clinical Observation Event Global Tracker.

ClinicalTrial Observation Event Global Tracker(PORT_AR010001UV01)

The application role includes the behaviors needed to receive and appropriately manage notifications from another system about any change of a Clinical Trial Observation Event. This includes receiving information about status changes of that event and receipt of observation event information once that is available.


Interaction Design Elements & Descriptions: Trigger Event

Agreed Transmission Criterion Attained – CT(PORT_TE010001UV01)

An external event has occurred which marks a condition under which the sender and receiver have agreed that data is to be exchanged. Such events are often defined time points (e.g. end of business day/week/month). In a clinical trial, these may be significant milestones (e.g. subject enrolled; subject completes phase; all subjects complete phase; end of study).

CT Laboratory Results Adverse Event Assessment Request(PORT_IN03000x)

This interaction supports communication of clinical laboratory results to an AE assessment service. It is expected that the receiving application will initiate the CT Laboratory Results AE Assessment Response interaction (PORT_IN03000y) containing the original clinical laboratory results, in addition to the outcome of the initial / first-level quantitative adverse event assessment.

CT Laboratory Results Adverse Event Assessment Response(PORT_IN03000y)

This interaction supports communication of clinical laboratory results with the outcome of the initial / first-level quantitative adverse event assessment to a clinical information system within the clinical research environment / study site.


Interaction Design Elements & Descriptions: Interactions

CT Laboratory Results Adverse Event Assessment Request (PORT_IN03000x)

This interaction supports communication of clinical laboratory results to an AE assessment service. It is expected that the receiving application will initiate the CT Laboratory Results AE Assessment Response interaction (PORT_IN03000y) containing the original clinical laboratory results, in addition to the outcome of the initial / first-level quantitative adverse event assessment.

Trigger Event Agreed Transmission Criterion Attained - CT PORT_TE010001UV01

Transmission Wrapper Send Message Payload MCCI_MT000100UV01

Control Act Wrapper Trigger Event Control Act MCAI_MT700201UV01

Message Type CTLaboratory Observation, base PORT_MT030001UV01

Sender ClinicalTrial Observation Order Global Placer PORT_AR03000x

Receiver Adverse Event Assessment Observation Fulfiller PORT_AR03000y

Receiver Clinical Trial Observation Order Global Tracker PORT_ AR010001UV01

Reason Trigger Event InteractionInitiate AE Assessment response with initial / first-level AE assessment outcome

PORT_TE010001UV01 PORT_IN03000y

Sending and Receiving Roles

Receiver Responsibilities


Interaction Design Elements: Interactions Cont’d

CT Laboratory Results Adverse Event Assessment Response (PORT_IN03000y)

This interaction supports communication of clinical laboratory results with the outcome of the initial / first-level quantitative adverse event assessment to a clinical information system within the clinical research environment / study site.

Trigger Event Agreed Transmission Criterion Attained - CT PORT_TE010001UV01

Transmission Wrapper Send Message Payload MCCI_MT000100UV01

Control Act Wrapper Trigger Event Control Act MCAI_MT700201UV01

Message Type CTLaboratory Observation, AE Assessed PORT_MT03000x

Sender Adverse Event Assessment Observation Fulfiller PORT_AR03000y

Receiver Clinical Trial Observation Event Global Tracker PORT_AR010001UV01

Sending and Receiving Roles


LabTestResult

- resultValue: float

LabTestType

- identifier: string- name: string- unitOfMeasure: string- lowerLimitNormal: float- upperLimitNormal: float

Person

- identifier: String- firstName: String- lastName: String

Specimen

- accessionNumber: int- collectionDateTime: dateTime

AdverseEventAssessment

- assessmentRuleKind: String- assessmentStatus: String

AdverseEventTerm

- name: String

Grade

- CTCAEGrade: String

GradeAnnotation

- conditionalGradeDescription: String

ExceptionMessage

- exceptionMessageText: String

AdverseEventCategory

- name: StringEntry Point

«Invariant»{XOR}

1

1..*

0..* 1

1 0..*

0..*

1

1..* 0..1

0..*

1

1..*1

1 1..*

1..*

1

Lab-Based Adverse Event Assessment Domain Analysis Model

Current CT-Lab Message Content

Proposed New CMET Content


BRIDG-Derived Domain Analysis Model


Current CT Laboratory Message RMIM

1..1subjectIdentif icationrecordTarget

typeCode *: <= RCTcontextControlCode: <= OP

1..1 trialSite

locationtypeCode*: <= LOCcontextControlCode: <= OP

0..1 trialInv estigator

responsiblePartytypeCode *: <= RESPcontextControlCode: <= OP

NaturalMaterialclassCode *: <= ENTdeterminerCode *: <= INSTANCEcode: CV CWE [1..1] <= SpecimenEntityType (specimen material code and name)

LaboratoryclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [1..1] (lab identif ier)name: TN [0..1] (lab name)

PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname: PN [0..1] (subject initials)administrativ eGenderCode: CV CWE [0..1] <= AdministrativeGenderbirthTime: TS [0..1]raceCode: CV CWE [0..1] <= RACE

SiteclassCode *: <= PLCdeterminerCode *: <= INSTANCE

NamedPersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname: TN [0..1] (Cue: INVNAME)

SpareSubject 1..1 asSpareSubject

classCode *: <= RESBJid: II [1..1] (Auxilliary Subject ID)code: CE CWE [0..1] <= ResearchSubjectRoleBasis

0..1 subjectPerson

ScreeningSubjectclassCode *: <= RESBJid: II [1..1] (Subject ID f or screening)code: CE CWE [0..1] <=ResearchSubjectRoleBasis

1..1 representedLaboratory

AgentclassCode *: <= AGNT

0..1 specimenNaturalMaterial

BaseSpecimenclassCode *: <= SPECid: II [0..1] (container number)

0..1 subjectPerson

EnrolledSubjectclassCode *: <= RESBJid: II [0..1] (permanent subject ID)code: CE CWE [0..1] <=ResearchSubjectRoleBasis

0..1 inv estigatorNamedPerson

TrialInvestigatorclassCode *: <= CRINVid: II [0..1] (Inv estigator ID)

0..1 location

TrialSiteclassCode *: <= SDLOCid: II [1..1] (Site ID)

0..* specimenComment

subjectOf1typeCode *: <= SBJcontextControlCode: <= OP

1..1 specimenCollectionProcedure

productOftypeCode*: <= PRDcontextControlCode: <= OP

1..* baseSpecimen

subjecttypeCode*: <= SBJcontextControlCode: <= OP

1..1 agent

authortypeCode *: <= AUTcontextControlCode: <= OP

0..1 containerRegistration

subjectOf2typeCode*: <= SBJcontextControlCode: <= OP

1..1 agent

performertypeCode *: <= PRFcontextControlCode: <= OP

CT Laboratory Observation Periodic Report(PORT_RM030001)

Description: Used f or reporting clinicallaboratory ev ents to the sponsor of aclinical trial.

Constraint: nminvariant( x) { x.;} type component must be "initials"

Note:Specimen ConditionLab Specimen CommentInv Specimen Comment

TrialAtSiteclassCode *: <= CLNTRLmoodCode *: <= EVN

SubjectAssignmentclassCode *: <= CLNTRLmoodCode*: <= EVN

InvestigatorAtSiteclassCode *: <= CLNTRLmoodCode*: <= EVN

ReferenceEventclassCode *: <= ACTmoodCode*: <= DEFcode: <= ActCode (name & code f or the Ref erenceEv ent)

ProtocolStudyEventclassCode *: <= CLNTRLmoodCode *: <= DEF

ProtocolSpecimenCollectionclassCode *: <= PROCmoodCode*: <= DEF

FastingStatusclassCode *: <= OBSmoodCode *: <= EVNcode: CV CWE [1..1] (code f or "f asting status")v alue: ST [1..1] (f asting status at time of collection)

SpecimenCommentclassCode *: <= OBSmoodCode *: <= EVNcode: CV CWE [1..1] <= ExternallyDefinedActCodes (Cue: id f or cond, comm)v alue: ED [1..1] (Cue: SPCMCNDT;SPCNCMMT)

AccessionclassCode *: <= ACSNmoodCode *: <= EVNid: II [0..1] (Accession Number)activ ity Time: IVL<TS> [0..1] (last activ ity date/time)

SpecimenCollectionProcedureclassCode *: <= PROCmoodCode *: <= EVNef f ectiv eTime: IVL<TS> [1..1] (Cue: start/enddatetime)

BaseBatteryclassCode *: <= OBSmoodCode *: <= EVNcode: CV CWE [1..1] (panel code and name)

ContainerRegistrationclassCode *: <= CONTREGmoodCode *: <= EVNcode: CD CWE [0..1] <= ActContainerRegistrationCode "I"ef f ectiv eTime: TS [0..1] (date/time receiv ed at laboratory )

StudyEventclassCode *: <= CTTEVENTmoodCode *: <= EVNcode*: CV CWE [1..1] (v isit number & name)reasonCode: CE CWE [0..1] <= ActReason (v isit ty pe: scheduled, retest, etc.)

ClinicalTrialclassCode *: <= CLNTRLmoodCode *: <= EVNid: II [1..1] (study id)title: ST [0..1]

AgeAtVisitclassCode *: <= OBSmoodCode *: <= EVNcode*: CV CWE [1..1] (code f or "age")value*: PQ [1..1] (age/UOM at time of collection)

TestCommentclassCode *: <= OBSmoodCode*: <= EVNtext: ST [0..1] (test comment)

RangeclassCode *: <= OBSmoodCode *: <= EVNv alue: PQ [1..1] (contains both high & low limits)

ToxicityGradeclassCode *: <= OBSmoodCode *: <= EVNcode: CD CWE [1..1] <= LogicalObservationIdentifierNamesAndCodesvalue*: CV [1..1] <= ObservationValue (grade and code sy stem)

BaseUnitaryResultclassCode *: <= OBSmoodCode*: = EVNcode: CV CWE [0..1] (result id)text: ED [0..1] (additional description)statusCode: CS CNE [1..1] (test status)activ ity Time: IVL<TS> [0..1] (date/time test perf ormed)conf identiality Code: SET<CE> CWE [0..*] <= Confidentiality (blinding f lag f or test)reasonCode: CV CWE [0..1] (reason perf ormed - per protocol, etc.)v alue: PQ [0..1] (text result, num res,unit, unit sy stem, ..., reported result ty pes [C N T R] in xsity pe)interpretationCode: SET<CE> CWE [0..*] <= ObservationInterpretation (alert, delta, exclusion f lags)methodCode: CV CWE [0..1] (greater than/ less than quantif iable limit)

ReportToSiteclassCode *: <= CACTmoodCode *: <= EVNstatusCode: CS CNE [0..1]ef f ectiv eTime: GTS [0..1] (report date/time)

BaseSpecimenDefinitionclassCode *: <= ACTmoodCode *: <= EVN

1..1 protocolStudy Ev entcomponentOftypeCode *: <= COMPcontextConductionInd: "true"pauseQuantity : (of f set f rom the Ref erenceEv ent)

0..1 ageAtVisit

typeCode *: <= PERTcontextControlCode: <= AP

0..1 toxicity Grade

pertinentInformation2typeCode *: <= PERTcontextConductionInd: "true"

0..1 reportToSite

subjectOftypeCode *: <= SUBJcontextConductionInd: "true"

0..* trialAtSite

componenttypeCode *: <= COMPcontextConductionInd: "true"

0..* subjectAssignment


0..* inv estigatorAtSite

componenttypeCode*: <= COMPcontextConductionInd: "true"

0..* study Ev ent


0..* accession


0..1 protocolSpecimenCollection

definitiontypeCode *: <= INSTcontextConductionInd: "true"

0..1 f astingStatus

pertinentInformation1typeCode*: <= PERTcontextControlCode: <= AP

0..* baseSpecimenDef inition

componenttypeCode *: <= COMPcontextConductionInd: "true" 0..* baseBattery


1..1 ref erenceEv ent


0..1 range

referenceRangetypeCode *: <= REFVcontextConductionInd: "true"

0..* testComment

pertinentInformation1typeCode *: <= PERTcontextControlCode: <= AP

0..* baseUnitary ResultcomponenttypeCode*: <= COMPcontextConductionInd: "true"

SubjectIdentification

invariant( x) { x.;}for any single instance of the Person class,the played instances of ScreeningSubject andScreeningSubject2 represent the same instanceof the ScreeningSubject Role.

Constraint:

ScreeningSubject2 0..* asScreeningSubject

classCode *: <= RESBJid: II [0..1] (Subject ID f or screening)code: CE CWE [0..1] <=ResearchSubjectRoleBasis


1..1 subjectIdentif ication

recordTargettypeCode *: <= RCTcontextControlCode: <= OP

1..1 trialSite

locationtypeCode*: <= LOCcontextControlCode: <= OP

0..1 trialInv estigator

responsiblePartytypeCode *: <= RESPcontextControlCode: <= OP

NaturalMaterialclassCode *: <= ENTdeterminerCode *: <= INSTANCEcode: CV CWE [1..1] <= SpecimenEntityType (specimen material code and name)

LaboratoryclassCode *: <= ORGdeterminerCode *: <= INSTANCEid: II [1..1] (lab identif ier)name: TN [0..1] (lab name)

PersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname: PN [0..1] (subject initials)administrativ eGenderCode: CV CWE [0..1] <= AdministrativeGenderbirthTime: TS [0..1]raceCode: CV CWE [0..1] <= RACE

SiteclassCode *: <= PLCdeterminerCode *: <= INSTANCE

NamedPersonclassCode *: <= PSNdeterminerCode *: <= INSTANCEname: TN [0..1] (Cue: INVNAME)

SpareSubject 1..1 asSpareSubject

classCode *: <= RESBJid: II [1..1] (Auxilliary Subject ID)code: CE CWE [0..1] <= ResearchSubjectRoleBasis

0..1 subjectPerson

ScreeningSubjectclassCode *: <= RESBJid: II [1..1] (Subject ID f or screening)code: CE CWE [0..1] <ResearchSubjectRoleBasis

1..1 representedLaboratory

AgentclassCode *: <= AGNT

0..1 specimenNaturalMaterial

BaseSpecimenclassCode *: <= SPECid: II [0..1] (container number)

0..1 subjectPerson

EnrolledSubjectclassCode *: <= RESBJid: II [0..1] (permanent subject ID)code: CE CWE [0..1] <ResearchSubjectRoleBasis

0..1 inv estigatorNamedPerson

TrialInvestigatorclassCode *: <= CRINVid: II [0..1] (Inv estigator ID)

0..1 location

TrialSiteclassCode *: <= SDLOCid: II [1..1] (Site ID)

0..* specimenComment

subjectOf1typeCode *: <= SBJcontextControlCode: <= OP

1..1 specimenCollectionProcedure

productOftypeCode *: <= PRDcontextControlCode: <= OP

1..* baseSpecimen

subjecttypeCode *: <= SBJcontextControlCode: <= OP

1..1 agent

authortypeCode *: <= AUTcontextControlCode: <= OP

0..1 containerRegistration

subjectOf2typeCode*: <= SBJcontextControlCode: <= OP

1..1 agent

performertypeCode *: <= PRFcontextControlCode: <= OP

CT Laboratory Observation Periodic Report (City of Hope)(PORT_RM030001CH01)

Description: Used f or reporting clinicallaboratory ev ents to the sponsor of aclinical trial.

Constraint: nminvariant( x) { x.;} type component must be "initials"

Note:Specimen ConditionLab Specimen CommentInv Specimen Comment

TrialAtSiteclassCode *: <= CLNTRLmoodCode *: <= EVN

SubjectAssignmentclassCode *: <= CLNTRLmoodCode *: <= EVN

InvestigatorAtSiteclassCode *: <= CLNTRLmoodCode *: <= EVN

ReferenceEventclassCode *: <= ACTmoodCode *: <= DEFcode: <= ActCode (name & code f or the Ref erenceEv ent)

ProtocolStudyEventclassCode *: <= CLNTRLmoodCode *: <= DEF

ProtocolSpecimenCollectionclassCode *: <= PROCmoodCode *: <= DEF

FastingStatusclassCode *: <= OBSmoodCode *: <= EVNcode: CV CWE [1..1] (code f or "f asting status")v alue: ST [1..1] (f asting status at time of collection)

SpecimenCommentclassCode *: <= OBSmoodCode *: <= EVNcode: CV CWE [1..1] <= ExternallyDefinedActCodes (Cue: id f or cond, comm)v alue: ED [1..1] (Cue: SPCMCNDT;SPCNCMMT)

AccessionclassCode *: <= ACSNmoodCode *: <= EVNid: II [0..1] (Accession Number)activ ity Time: IVL<TS> [0..1] (last activ ity date/time)

SpecimenCollectionProcedureclassCode *: <= PROCmoodCode *: <= EVNef f ectiv eTime: IVL<TS> [1..1] (Cue: start/end datetime)

BaseBatteryclassCode *: <= OBSmoodCode *: <= EVNcode: CV CWE [1..1] (panel code and name)

ContainerRegistrationclassCode *: <= CONTREGmoodCode *: <= EVNcode: CD CWE [0..1] <= ActContainerRegistrationCode "I"ef f ectiv eTime: TS [0..1] (date/time receiv ed at laboratory )

StudyEventclassCode *: <= CTTEVENTmoodCode *: <= EVNcode*: CV CWE [1..1] (v isit number & name)reasonCode: CE CWE [0..1] <= ActReason (v isit ty pe: scheduled, retest, etc.)

ClinicalTrialclassCode *: <= CLNTRLmoodCode *: <= EVNid: II [1..1] (study id)title: ST [0..1]

AgeAtVisitclassCode *: <= OBSmoodCode *: <= EVNcode*: CV CWE [1..1] (code f or "age")value*: PQ [1..1] (age/UOM at time of collection)

TestCommentclassCode *: <= OBSmoodCode *: <= EVNtext: ST [0..1] (test comment)

RangeclassCode *: <= OBSmoodCode *: <= EVNvalue*: IVL<PQ> [1..1] (contains both high & low limits)

ToxicityGradeclassCode *: <= OBSmoodCode *: <= EVNcode: CD CWE [1..1] <= LogicalObservationIdentifierNamesAndCodesvalue*: CV [1..1] <= ObservationValue (grade and code sy stem)

BaseUnitaryResultclassCode *: <= OBSmoodCode *: = EVNcode: CV CWE [0..1] (result id)text: ED [0..1] (additional description)statusCode: CS CNE [1..1] (test status)activ ity Time: IVL<TS> [0..1] (date/time test perf ormed)conf identiality Code: SET<CE> CWE [0..*] <= Confidentiality (blinding f lag f or test)reasonCode: CV CWE [0..1] (reason perf ormed - per protocol, etc.)v alue: PQ [0..1] (text result, num res,unit, unit sy stem, ..., reported result ty pes [C N T R] in xsity pe)interpretationCode: SET<CE> CWE [0..*] <= ObservationInterpretation (alert, delta, exclusion f lags)methodCode: CV CWE [0..1] (greater than/ less than quantif iable limit)

ReportToSiteclassCode *: <= CACTmoodCode *: <= EVNstatusCode: CS CNE [0..1]ef f ectiv eTime: GTS [0..1] (report date/time)

BaseSpecimenDefinitionclassCode *: <= ACTmoodCode *: <= EVN

1..1 protocolStudy Ev entcomponentOftypeCode *: <= COMPcontextConductionInd: "true"pauseQuantity : (of f set f rom the Ref erenceEv ent)

0..1 ageAtVisit


0..1 toxicity Grade

pertinentInformation3typeCode *: <= PERTcontextConductionInd: BL [0..1] "true"

0..1 reportToSite

subjectOftypeCode*: <= SUBJcontextConductionInd: "true"

0..* trialAtSite


0..* subjectAssignment


0..* inv estigatorAtSite


0..* study Ev ent


0..* accession


0..1 protocolSpecimenCollection

definitiontypeCode *: <= INSTcontextConductionInd: "true"

0..1 f astingStatus


0..* baseSpecimenDef inition

componenttypeCode *: <= COMPcontextConductionInd: "true" 0..* baseBattery


1..1 ref erenceEv ent


0..1 range

referenceRangetypeCode *: <= REFVcontextConductionInd: BL [0..1] ="True"

0..* testComment


0..* baseUnitary ResultcomponenttypeCode *: <= COMPcontextConductionInd: "true"

SubjectIdentification

invariant( x) { x.;}for any single instance of the Person class,the played instances of ScreeningSubject andScreeningSubject2 represent the same instanceof the ScreeningSubject Role.

Constraint:

ScreeningSubject2 0..* asScreeningSubject

classCode *: <= RESBJid: II [0..1] (Subject ID f or screening)code: CE CWE [0..1] <=ResearchSubjectRoleBasis

0..* adv erseEv entAssessment

typeCode*: <= "SUBJ"contextConductionInd: BL [0..1] "True"

subjectOf1CMET: (OBS)

A_AdverseEventAssessment[universal ]

(COCT_MT120610UV)

CMET Addition to the CT-Laboratory Message


Proposed Changes to the CT-Laboratory Message

1. Change datatype of Range.value from PQ to IVL<PQ>.

2. Add AdverseEventAssessment CMET with an ActRelationship to Base Unitary Result

RangeclassCode*: <= OBSmoodCode*: <= EVNvalue*: IVL<PQ> [1..1] (contains both high & low limits)

BaseUnitaryResultclassCode*: <= OBSmoodCode*: = EVNcode: CV CWE [0..1] (result id)text: ED [0..1] (additional description)statusCode: CS CNE [1..1] (test status)activityTime: IVL<TS> [0..1] (date/time test performed)confidentialityCode: SET<CE> CWE [0..*] <= Confidentiality (blinding flag for test)reasonCode: CV CWE [0..1] (reason performed - per protocol, etc.)value: PQ [0..1] (text result, num res,unit, unit system, ..., reported result types [C N T R] in xsitype)interpretationCode: SET<CE> CWE [0..*] <= ObservationInterpretation (alert, delta, exclusion flags)methodCode: CV CWE [0..1] (greater than/ less than quantifiable limit)

0..1 range

referenceRangetypeCode*: <= REFVcontextConductionInd: BL [0..1] ="True"

0..* adverseEventAssessment

typeCode*: <= "SUBJ"contextConductionInd: BL [0..1] "True"

subjectOf1CMET: (OBS)

A_AdverseEventAssessment[universal]

(COCT_MT120610UV)

1. Range.value datatype has been changed from PQ to IVL <PQ>

2. Add AdverseEventAssessment CMET with an ActRelationship to Base Unitary Result


CMET RMIM

AdverseEventAssessment

classCode*: = "OBS"moodCode*: = "EVN"code*: CD CNE [1..1] <= V:ObservationTypestatusCode*: CS CNE [1..1] <= V:ActStatusactivityTime*: TS.DATETIME [1..1]uncertaintyCode: CE CNE [0..1] <= V:ActUncertaintyvalue: CD CWE [0..1] <= V:AdverseEventmethodCode: SET<CE> CWE [0..*] <= V:AdverseEventAssessmentMethod

1..* assessmentOutcome

typeCode*: = "OUTC"contextConductionInd*: BL [1..1] "True"

outcome

AssessmentOutcome

AssessmentException

classCode*: = "OBS"moodCode*: = "EVN"code*: CD CWE [1..1] <= V:ActCodevalue*: SC CWE [1..1] <= V:AdverseEventAssessmentException

AdverseEventGrade

classCode*: = "OBS"moodCode*: = "EVN"code*: CD CWE [1..1] <= V:ActCodevalue*: CD CWE [1..1] <= V:AdverseEventGrade

0..1 gradeAnnotation

typeCode*: = "APND"contextConductionInd*: BL [1..1] "True"

appendage

GradeAnnotation

classCode*: = "OBS"moodCode*: = "EVN"code*: CD CWE [1..1] <= V:ActCodevalue*: SC CWE [1..1] <= V:AdverseEventGradeAnnotation

AdverseEventAssessment(COCT_RM120610VU01)

Description:


CMET RMIM Class Definitions

AdverseEventAssessment The process of evaluating a clinical finding to detect the presence and severity of an abnormal condition, and assigning the corresponding adverse event category, term, and grade.

AssessmentExceptionThis class represents one of two possible observation outcomes of an AdverseEventAssessment. It is a message provided to indicate that an adverse event assessment could not be executed or completed and to identify the reason for the failure.

AdverseEventGradeThis class represents one of two possible observation outcomes of the AdverseEventAssessment. It is the severity of an adverse event based on a specified assessment scale.

GradeAnnotationAdditional information provided about a grade that must be considered to determine the final grade.


Hierarchical Message Description

No Element Name Card Rim Source MET Domain CS Nt

(Link to tabular view)

AdverseEventAssessment Common message for COCT_HD120610VU01

1 AdverseEventAssessment 0..1 Observation AdverseEventAssessment

2 classCode 1..1 Act CS OBS CNE

3 moodCode 1..1 Act CS EVN CNE

4 code 1..1 Act CD V:ObservationType CNE Adverse_Reaction

5 statusCode 1..1 Act CS V:ActStatus CNE

6 activityTime 1..1 Act TS.DATETIME

7 uncertaintyCode 0..1 Act CE V:ActUncertainty CNE Required when statusCode = 'Completed'.

8 value 0..1 Observation CD V:AdverseEvent CWE Required when statusCode = 'Completed'

9 methodCode 0..* Observation SET<CE> V:AdverseEventAssessmentMethod CWE Required when statusCode = 'Completed'.

10 outcome 1..* Act SET<Outcome>

11 typeCode 1..1 ActRelationship CS OUTC CNE

12 contextConductionInd 1..1 ActRelationship BL Default: True

13 assessmentOutcome 1..1 ActRelationship AssessmentOutcome | AdverseEventGrade | AssessmentException

14 assessmentOutcome_AdverseEventGrade 1..1 Act AdverseEventGrade



17 code 1..1 Act CD V:ActCode CWE SEV

18 value 1..1 Observation CD V:AdverseEventGrade CWE

19 appendage 0..1 Act Appendage

20 typeCode 1..1 ActRelationship CS APND CNE

21 contextConductionInd 1..1 ActRelationship BL Default: True

22 gradeAnnotation 1..1 ActRelationship GradeAnnotation



25 code 1..1 Act CD V:ActCode CWE ASSERTION

26 value 1..1 Observation SC

27 assessmentOutcome_AssessmentException 1..1 Act AssessmentException



30 code 1..1 Act CD V:ActCode CWE ASSERTION

31 value 1..1 Observation SC


Vocabulary Requirements

Vocabulary requirements have been identified in the following areas:

External reference to a new code system

• Common Terminology Criteria for Adverse Events v3.0 (CTCAE): contains the adverse event category, adverse event term and adverse event short term that may be used to describe an adverse event.

New value sets for existing domains

• Adverse Event Assessment Method: provides additional information about the means used to arrive at the assessment result.

• Adverse Event Assessment Exception: provides the reason an adverse event assessment could not be executed or completed

• Adverse Event Grade: indicates the level of severity for an adverse event, including the concept of Not Present.

• Adverse Event Grade Annotation: provides additional information about an adverse event assessment grade, which must be considered before determining the final grade.

Focused discussion regarding these vocabulary requirements will be held during the working group meeting. The session is to be determined.


Motions

RCRIM TC approval for the submission of the following items for RIM harmonization:

New code system• Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

New value sets• AdverseEventAssessmentMethod• AdverseEventAssessmentException• AdverseEventGrade• AdverseEventGradeAnnotation

RCRIM TC approval for the submission of the following items for inclusion in the January 2008 ballot as a DSTU:

Adverse Event Assessment CMET Revised HL7 v3 CT Laboratory Message New application roles

• ClinicalTrial Observation Order Global Placer• Adverse Event Assessment Observation Fulfiller

New interactions• CT Laboratory Results Adverse Event Assessment Request• CT Laboratory Results Adverse Event Assessment Response


Next Steps

Activity Responsible Start Date End Date

RIM Vocabulary HarmonizationTeam / Vocab

Facilitator Nov 8, 2007 Nov 9, 2007

Prepare ballot material: CMET Specifications package

JLN/ Publishing Facilitator Oct 1, 2007 Nov 4, 2007

Prepare ballot material: CT Laboratory Message

PP / Publishing Facilitator Oct 1, 2007 Nov 4, 2007

Review and edit final ballot material

JLN/ Publishing Facilitator Nov 11, 2007 Nov 24, 2007

Ballot Period Dec 2, 2007 Jan 7, 2008

Ballot reconciliation RCRIM Jan 17, 2008 Jan 22, 2008

Create Implementation Guide (post successful ballot)

Team Jan 2008 Jan 2008

HL7 Version 3 Laboratory Result-based Adverse Event Assessment Message Specifications RCRIM Technical Meeting September 18, 2007 Jennifer Neat Project.

Documents

adverse event assessment

quantitative ae assessment

level assessment

ae assessment outcome

trigger event

external event

adverse events v3

laboratory resultbased