Transcript Slide 1

HL7 Version 3
Adverse Event Assessment
CMET Specification
Jennifer Neat
Project Leader, City of Hope
August 7, 2007
Project Context: Lifecycle of an Adverse Event
act Life Cycle: Lab-based Quantitativ e AE
Performing Lab System
Lab-based AE Detection&Grading Serv
Clinical Information/CT Mgmt/AE Mgmt Sys
Clinical Research Staff
AE Reporting Sys (Sponsor, Reg Agency)
ActivityInitial
1.0 Perform Lab Test
Project Scope
2.0 Report Lab Test
Result
3.0 Perform Lab-based
Quantitativ e AE
Assessment
4.0 Create Record
5.0 Rev iew Initial
Lab-based Quantitativ e
AE Assessment Results
[No AE Investigation]
[Investigate]
«HL7 v3 CT Lab Msg»
Lab Test Result
6.0 Conduct Lab-based
Quantitativ e AE
Inv estigation
«HL7 v3 Msg»
Annotated Lab Test
Result
[AE Not Present]
7.0 Update Record w ith
AE Inv estigation Results
[Reportable AE]
8.0 Report AE
Inv estigation Results
«HL7 v3 ICSR Msg»
AE Inv estigation Report
ActivityFinal
August 7, 2007
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
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Lab-Based Adverse Event Assessment Domain Analysis Model
Person
-
Current CT-Lab Message Content
Specimen
identifier: String
firstName: String 1
lastName: String
1..* -
accessionNumber: int
collectionDateTime: dateTime
Proposed New CMET Content
1
1..*
LabTestType
-
identifier: string
name: string
unitOfMeasure: string
lowerLimitNormal: float
upperLimitNormal: float
LabTestResult
1
ExceptionMessage
-
-
1..*
AdverseEventCategory
Entry Point
resultValue: float
-
1
1
0..*
1..*
AdverseEventAssessment
exceptionMessageText: String
0..*
1 -
name: String
AdverseEventTerm
assessmentRuleKind: String
assessmentStatus: String
1..*
0..1
-
name: String
1
«Invariant»
{XOR}
0..*
Grade
-
August 7, 2007
CTCAEGrade: String
GradeAnnotation
1
0..*
-
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
conditionalGradeDescription: String
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Current CT Laboratory Message RMIM
CT Laboratory Observation Periodic Report
ClinicalTrial
(PORT_RM030001
)
classCode *: <= CLNTRL
moodCode *: <= EVN
id: II [1..1] (study id)
title: ST[0..1]
Description: Used f or reporting clinical
laboratory ev ents to the sponsor of a
clinicaltrial.
Constraint: nm
invariant
( x) {
x.;
}typecomponentmustbe"initials"
Site
classCode *: <= PLC
determinerCode *: <= INSTANCE
com ponent
typeCode *: <= COMP
contextConductionInd: "true" 0..* trialAtSite
TrialAtSite
location
classCode *: <= CLNTRL
moodCode *: <= EVN
typeCode *: <= LOC
contextControlCode: <=OP
InvestigatorAtSite
invariant
( x) {
x.;
}foranysingleinstanceofthePersonclass,
theplayedinstancesofScreeningSubjectand
ScreeningSubject2representthesameinstance
oftheScreeningSubjectRole.
TrialSite
Nam edPerson
classCode *: <= SDLOC
id: II [1..1] (SiteID)
classCode *: <= PSN
determinerCode *: <= INSTANCE
name: TN [0..1] (Cue: INVNAME)
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
Constraint:
0..1location
1..1trialSite
ReportToSite
classCode *: <= OBS
moodCode *: = EVN
Person
code: CV CWE [0..1] (result id)
0..1subjectPerson classCode *: <= PSN
text: ED [0..1] (additional description)
determinerCode *: <= INSTANCE
statusCode: CSCNE [1..1] (test status)
name:
PN
[0..1]
(subject
initials)
0..1subjectPerson
activ ity Time: IVL<TS> [0..1] (date/timetest perf ormed)
administrativ eGenderCode: CVCWE [0..1] <= AdministrativeGender conf identiality Code: SET<CE>CWE[0..*]
birthTime: TS[0..1]
<= Confidentiality (blinding f lag f or test)
raceCode: CV CWE [0..1] <= RACE
reasonCode: CVCWE [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)
Laboratory
interpretationCode: SET<CE>CWE[0..*]
classCode *: <= ORG
<= ObservationInterpretation
determinerCode *: <= INSTANCE
(alert, delta, exclusion f lags)
id: II [1..1] (lab identif ier)
methodCode: CVCWE[0..1]
name: TN [0..1] (lab name)
(greater than/ less than quantif iable limit)
1..1 representedLaboratory
0..* inv estigatorAtSite
0..1trialInv estigator
responsibleParty
TrialInvestigator
classCode *: <= CRINV
id: II [0..1] (Inv estigatorID)
classCode *: <= CLNTRL typeCode *: <= RESP
moodCode *: <= EVN
contextControlCode: <= OP
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
SubjectIdentification
0..* subjectAssignment
SubjectAssignm ent
classCode *: <= CLNTRL
moodCode *: <= EVN
EnrolledSubject
classCode *: <= RESBJ
id: II [0..1] (permanent subject ID)
code: CE CWE[0..1] <=
ResearchSubjectRoleBasis
1..1
subjectIdentif ication
recordTarget
typeCode *: <= RCT
contextControlCode: <= OP
subjectOf
BaseUnitaryResult
0..1inv estigatorNamedPerson
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
classCode *: <= CACT
moodCode *: <= EVN
typeCode *: <= SUBJ
statusCode: CSCNE[0..1]
contextConductionInd: "true"
0..1 reportToSite ef f ectiv eTime: GTS[0..1] (report date/time)
0..1 range
referenceRange
typeCode *: <= REFV
contextConductionInd: "true"
ScreeningSubject2
classCode *: <= RESBJ
id: II [1..1] (Subject ID f or screening)
code: CE CWE[0..1] <=
ResearchSubjectRoleBasis
classCode *: <= RESBJ
id: II [0..1] (Subject ID f or screening)
code: CE CWE[0..1] <=
ResearchSubjectRoleBasis
classCode *: <= OBS
moodCode *: <= EVN
v alue: PQ [1..1] (contains both high & low limits)
0..1toxicity Grade
pertinentInform ation2
typeCode *: <= PERT
contextConductionInd: "true"
ToxicityGrade
classCode *: <= OBS
moodCode *: <= EVN
code: CD CWE [1..1] <= LogicalObservationIdentifierNamesAndCodes
value *: CV [1..1] <= ObservationValue (grade and code sy stem)
0..* asScreeningSubject
ScreeningSubject
Range
0..* testComment
pertinentInform ation1
typeCode *: <= PERT
contextControlCode: <= AP
TestCom m ent
classCode *: <= OBS
moodCode *: <= EVN
text: ST [0..1] (test comment)
1..1 asSpareSubject
SpareSubject
classCode *: <= RESBJ
id: II [1..1] (Auxilliary Subject ID)
code: CE CWE [0..1] <= ResearchSubjectRoleBasis
Accession
0..* study Ev ent
1..1 agent
1..1 agent
author
classCode *: <= ACSN
moodCode *: <= EVN
typeCode *: <= AUT
id: II [0..1] (Accession Number)
contextControlCode: <= OP
activ ity Time: IVL<TS>[0..1] (last activ ity date/time)
Agent
classCode *: <= AGNT
perform er
typeCode *: <= PRF
contextControlCode: <= OP
0..* baseUnitary Result
com ponent
StudyEvent
classCode *: <= CTTEVENT
moodCode *: <= EVN
code*: CV CWE [1..1] (v isit number & name)
reasonCode: CE CWE [0..1] <= ActReason
(v isit ty pe: scheduled, retest, etc.)
0..* accession
com ponent
com ponent
BaseSpecim enDefinition
typeCode *: <= COMP
contextConductionInd: "true"
typeCode *: <= COMP
contextConductionInd: "true"
classCode *: <= ACT
moodCode *: <= EVN
subjectOf2
classCode *: <= CONTREG
typeCode *: <= SBJ
moodCode *: <= EVN
contextControlCode: <=OP
code: CD CWE [0..1] <= ActContainerRegistrationCode "I" 0..1containerRegistration
ef f ectiv eTime: TS [0..1] (date/time receiv edat laboratory )
Specim enCom m ent
classCode *: <= OBS
moodCode *: <= EVN
code: CV CWE [1..1] <= ExternallyDefinedActCodes
(Cue: id f or cond, comm)
v alue: ED [1..1] (Cue: SPCMCNDT;SPCNCMMT)
0..* baseBattery
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
1..* baseSpecimen
ContainerRegistration
typeCode *: <= COMP
contextConductionInd: "true"
0..* baseSpecimenDef inition
BaseSpecim en
classCode *: <= SPEC
id: II [0..1] (container number)
classCode *: <= OBS
moodCode *: <= EVN
code: CV CWE [1..1] (panel code and name)
typeCode *: <= SBJ
contextControlCode: <= OP
ProtocolStudyEvent
classCode *: <= CLNTRL
moodCode *: <= DEF
Specim enCollectionProcedure
productOf
subjectOf1
classCode *: <= PROC
typeCode *: <= PRD
contextControlCode: <= OP
moodCode *: <= EVN
1..1specimenCollectionProcedure ef f ectiv eTime: IVL<TS> [1..1] (Cue: start/end
datetime)
typeCode *: <= SBJ
contextControlCode: <= OP
0..* specimenComment
Note:
SpecimenCondition
LabSpecimenComment
Inv SpecimenComment
subject
BaseBattery
com ponentOf
0..1 ageAtVisit
AgeAtVisit
classCode *: <= OBS
moodCode *: <= EVN
code *: CV CWE [1..1] (code f or "age")
value *: PQ [1..1] (age/UOM at time of collection)
typeCode *: <= PERT
contextControlCode: <= AP
typeCode *: <= COMP
contextConductionInd: "true"
1..1ref erenceEv ent
ReferenceEvent
classCode *: <= PROC
moodCode *: <= DEF
classCode *: <= ACT
moodCode *: <= DEF
code: <= ActCode
(name & code f or the Ref erenceEv ent)
0..1protocolSpecimenCollection
FastingStatus
0..1f astingStatus
classCode *: <= ENT
0..1specimenNaturalMaterial
determinerCode *: <= INSTANCE
code: CV CWE [1..1] <= SpecimenEntityType
(specimen material code and name)
classCode *: <= OBS
moodCode *: <= EVN
code: CV CWE [1..1] (code f or "f asting status")
v alue: ST [1..1] (f asting status at time of collection)
pertinentInform ation1
definition
typeCode *: <= PERT
contextControlCode: <= AP
typeCode *: <= INST
contextConductionInd: "true"
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
com ponent
ProtocolSpecim enCollection
NaturalMaterial
August 7, 2007
1..1protocolStudy Ev ent
typeCode *: <= COMP
contextConductionInd: "true"
pauseQuantity :
(of f set f rom the
Ref erenceEv ent)
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CMET Addition to the CT-Laboratory Message
CT Laboratory Observation Periodic Report (City of Hope)
ClinicalTrial
(PORT_RM030001CH01
)
classCode *: <= CLNTRL
moodCode *: <= EVN
id: II [1..1] (study id)
title: ST[0..1]
Description: Used f or reporting clinical
laboratory ev ents to the sponsor of a
clinicaltrial.
Constraint: nm
Site
invariant
( x) {
x.;
}typecomponentmustbe"initials"
classCode *: <= PLC
determinerCode *: <= INSTANCE
com ponent
0..1location
typeCode *: <= COMP
contextConductionInd: "true" 0..* trialAtSite
1..1trialSite
TrialAtSite
location
classCode *: <= CLNTRL
moodCode *: <= EVN
typeCode *: <= LOC
contextControlCode: <= OP
InvestigatorAtSite
classCode *: <= CLNTRL
moodCode *: <= EVN
invariant
( x) {
x.;
}foranysingleinstanceofthePersonclass,
theplayedinstancesofScreeningSubjectand
ScreeningSubject2representthesameinstance
oftheScreeningSubjectRole.
Nam edPerson
classCode *: <= SDLOC
id: II [1..1] (SiteID)
classCode *: <= PSN
determinerCode *: <= INSTANCE
name: TN [0..1] (Cue: INVNAME)
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
Constraint:
TrialSite
ReportToSite
0..* inv estigatorAtSite
0..1trialInv estigator
responsibleParty
Person
TrialInvestigator
0..1subjectPerson classCode *: <= PSN
determinerCode *: <= INSTANCE
0..1subjectPerson name: PN [0..1] (subject initials)
administrativ eGenderCode: CVCWE [0..1] <= AdministrativeGender
birthTime: TS[0..1]
raceCode: CV CWE [0..1] <= RACE
classCode *: <= CRINV
id: II [0..1] (Inv estigatorID)
typeCode *: <= RESP
contextControlCode: <= OP
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
SubjectIdentification
0..* subjectAssignment
SubjectAssignm ent
EnrolledSubject
1..1subjectIdentif ication
recordTarget
classCode *: <= CLNTRL
moodCode *: <= EVN
typeCode *: <= RCT
contextControlCode: <= OP
subjectOf
BaseUnitaryResult
0..1inv estigatorNamedPerson
classCode *: <= RESBJ
id: II [0..1] (permanent subject ID)
code: CE CWE[0..1] <
ResearchSubjectRoleBasis
Laboratory
classCode *: <= ORG
determinerCode *: <= INSTANCE
id: II [1..1] (lab identif ier)
name: TN [0..1] (lab name)
1..1 representedLaboratory
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
classCode *: <= OBS
moodCode *: = EVN
code: CV CWE [0..1] (result id)
text: ED [0..1] (additional description)
statusCode: CSCNE [1..1] (test status)
activ ity Time: IVL<TS> [0..1] (date/timetest perf ormed)
conf identiality Code: SET<CE>CWE[0..*]
<= Confidentiality (blinding f lag f or test)
reasonCode: CVCWE [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: CVCWE[0..1]
(greater than/ less than quantif iable limit)
classCode *: <= CACT
moodCode *: <= EVN
typeCode *: <= SUBJ
statusCode: CSCNE[0..1]
contextConductionInd: "true"
0..1 reportToSite ef f ectiv eTime: GTS[0..1] (report date/time)
0..1 range
ScreeningSubject2
classCode *: <= RESBJ
id: II [1..1] (Subject ID f or screening)
code: CE CWE[0..1] <
ResearchSubjectRoleBasis
classCode *: <= RESBJ
id: II [0..1] (Subject ID f or screening)
code: CE CWE[0..1] <=
ResearchSubjectRoleBasis
0..1toxicity Grade
pertinentInform ation3
typeCode *: <= PERT
contextConductionInd: BL
[0..1] "true"
ToxicityGrade
classCode *: <= OBS
moodCode *: <= EVN
code: CD CWE [1..1] <= LogicalObservationIdentifierNamesAndCodes
value *: CV [1..1] <= ObservationValue (grade and code sy stem)
0..* testComment
pertinentInform ation2
typeCode *: <= PERT
contextControlCode: <=AP
classCode *: <= RESBJ
id: II [1..1] (Auxilliary Subject ID)
code: CE CWE [0..1] <= ResearchSubjectRoleBasis
typeCode *: <= "SUBJ"
contextConductionInd: BL [0..1] "True"
0..* adv erseEv entAssessment
Agent
classCode *: <= AGNT
typeCode *: <= PRF
contextControlCode: <= OP
0..* baseUnitary Result
com ponent
BaseSpecim enDefinition
typeCode *: <= COMP
contextConductionInd: "true"
typeCode *: <= COMP
contextConductionInd: "true"
classCode *: <= ACT
moodCode *: <= EVN
classCode *: <= OBS
moodCode *: <= EVN
code: CV CWE [1..1] <= ExternallyDefinedActCodes
(Cue: id f or cond, comm)
v alue: ED [1..1] (Cue: SPCMCNDT;SPCNCMMT)
0..* baseBattery
com ponent
typeCode *: <= COMP
contextConductionInd: "true"
1..* baseSpecimen
Specim enCom m ent
typeCode *: <= COMP
contextConductionInd: "true"
0..* baseSpecimenDef inition
com ponent
subjectOf2
classCode *: <= CONTREG
typeCode *: <= SBJ
moodCode *: <= EVN
contextControlCode: <= OP
code: CD CWE [0..1] <= ActContainerRegistrationCode "I" 0..1containerRegistration
ef f ectiv eTime: TS [0..1] (date/time receiv edat laboratory )
BaseSpecim en
classCode *: <= SPEC
id: II [0..1] (container number)
subject
BaseBattery
classCode *: <= OBS
moodCode *: <= EVN
code: CV CWE [1..1] (panel code and name)
typeCode *: <= SBJ
contextControlCode: <= OP
ProtocolStudyEvent
classCode *: <= CLNTRL
moodCode *: <= DEF
Specim enCollectionProcedure
productOf
subjectOf1
classCode *: <= PROC
typeCode *: <= PRD
contextControlCode: <= OP
moodCode *: <= EVN
1..1specimenCollectionProcedure ef f ectiv eTime: IVL<TS>[1..1]
(Cue: start/end datetime)
typeCode *: <= SBJ
contextControlCode: <= OP
0..* specimenComment
Note:
SpecimenCondition
LabSpecimenComment
Inv SpecimenComment
com ponentOf
0..1 ageAtVisit
AgeAtVisit
pertinentInform ation2
classCode *: <= OBS
moodCode *: <= EVN
code*: CV CWE [1..1] (code f or "age")
value*: PQ [1..1] (age/UOM at time of collection)
typeCode *: <= PERT
contextControlCode: <= AP
1..1protocolStudy Ev ent
typeCode *: <= COMP
contextConductionInd: "true"
pauseQuantity :
(of f set f rom the
Ref erenceEv ent)
typeCode *: <= COMP
contextConductionInd: "true"
1..1ref erenceEv ent
ReferenceEvent
classCode *: <= PROC
moodCode *: <= DEF
classCode *: <= ACT
moodCode *: <= DEF
code: <= ActCode
(name & code f or the Ref erenceEv ent)
0..1protocolSpecimenCollection
FastingStatus
0..1f astingStatus
classCode *: <= ENT
0..1specimenNaturalMaterial
determinerCode *: <= INSTANCE
code: CV CWE [1..1] <= SpecimenEntityType
(specimen material code and name)
classCode *: <= OBS
moodCode *: <= EVN
code: CV CWE [1..1] (code f or "f asting status")
v alue: ST [1..1] (f asting status at time of collection)
pertinentInform ation1
definition
typeCode *: <= PERT
contextControlCode: <= AP
typeCode *: <= INST
contextConductionInd: "true"
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
com ponent
ProtocolSpecim enCollection
NaturalMaterial
August 7, 2007
(COCT_MT120610UV
)
perform er
com ponent
ContainerRegistration
CMET: (OBS)
A_AdverseEventAssessment
[universal ]
1..1 agent
1..1 agent
author
classCode *: <= ACSN
moodCode *: <= EVN
typeCode *: <= AUT
id: II [0..1] (Accession Number)
contextControlCode: <= OP
activ ity Time: IVL<TS>[0..1] (last activ ity date/time)
0..* accession
classCode *: <= OBS
moodCode *: <= EVN
text: ST [0..1] (test comment)
subjectOf1
StudyEvent
classCode *: <= CTTEVENT
moodCode *: <= EVN
code*: CV CWE [1..1] (v isit number & name)
reasonCode: CE CWE [0..1] <= ActReason
(v isit ty pe: scheduled, retest, etc.)
TestCom m ent
1..1 asSpareSubject
SpareSubject
0..* study Ev ent
classCode *: <= OBS
moodCode *: <= EVN
value*: IVL<PQ> [1..1] (contains both high & low limits)
typeCode *: <= REFV
contextConductionInd: BL
[0..1] ="True"
0..* asScreeningSubject
ScreeningSubject
Accession
Range
referenceRange
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Proposed CMET Specification
The adverse event (AE) assessment CMET communicates the following:
1) The status of each laboratory test result evaluation and AE assessment; AND
2) The assessment outcome for each laboratory test result, which includes either:
a) An error/exception message; OR
b) An AE category, term, grade, and if applicable, grade annotation
AdverseEventAssessm ent
(COCT_RM120610
)
Description
Adverse Event Assessment:
The process of evaluating the observation of a clinical finding,
including a laboratory test result, to detect the presence and
severity of an abnormal condition, and assign the
corresponding adverse event (AE) category, term and grade.
(When a laboratory test result is within normal limits/reveals
no abnormal condition, the AE for which the laboratory test is
evaluated is assessed as Not Present.)
AdverseEventAssessm ent
classCode *: <= "OBS"
moodCode *: <= EVN
code: CD CWE [0..1] <= V:AdverseEventAssessment
statusCode *: CS CNE [1..1] <= ActStatusNormal (assessmentStatus)
uncertaintyCode *: CE CNE[1..1] < ActUncertainty
(assessmentStatus)
v alue*: CD CWE[0..1] <= AdverseEvent
methodCode *: CE CWE [1..1] < ObservationMethod
(assessmentRuleKind)
outcom e
typeCode *: <= "OUTC"
contextConductionInd*: BL [1..1] ="True"
Assessment Exception:
An exception message indicating that an adverse event
assessment could not be executed or completed and
providing the reason for the failure.
1..* assessmentOutcome
Assessm entOutcom e
Assessm entException
classCode *: <= "OBS"
moodCode *: <= EVN
value *: ST [1..1] (errorMessageDescription)
Adverse Event Grade:
The level of severity for an assessed AE
AdverseEventGrade
Grade Annotation:
classCode *: <= "OBS"
moodCode *: <= EVN
value *: CD CWE [1..1] <= AEGrade (AEGrade)
The additional information regarding a grade returned with an
AE assessment
appendage
typeCode *: <= "APND"
contextConductionInd*: BL [1..1] ="True"
0..1 gradeAnnotation
GradeAnnotation
classCode *: <= "OBS"
moodCode *: <= EVN
value*: ST [1..1] (conditionalGradeDescription)
August 7, 2007
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
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Proposed Changes to the CT-Laboratory Message
BaseUnitaryResult
classCode*: <= OBS
moodCode*: = EVN
code: 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
referenceRange
typeCode*: <= REFV
contextConductionInd: BL
[0..1] ="True"
Range
classCode*: <= OBS
moodCode*: <= EVN
value*: IVL<PQ> [1..1] (contains both high & low limits)
1. Change datatype of Range.value
from PQ to IVL<PQ>.
2. Add AdverseEventAssessment
CMET with an ActRelationship to
Base Unitary Result
subjectOf1
typeCode*: <= "SUBJ"
contextConductionInd: BL [0..1] "True"
0..* adverseEventAssessment
August 7, 2007
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
CMET: (OBS)
A_AdverseEventAssessment
[universal]
(COCT_MT120610UV)
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Next Steps
Create BRIDG-derived
DAM
Identify vocabulary
harmonization changes
Review proposed
changes with Laboratory
Results for CT group
Harmonize with BRIDG
August 7, 2007
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
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Questions / Comments
August 7, 2007
HL7 V3 Lab-Based Adverse Event Assessment CMET Specification
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