| PORT_MT020002UV01 |
Description: Description: Used by the sponsor of a clinical trial for reporting annotated ECG waveform data to a regulatory agency in support of the sponsor's derived ECG findings. Derived from RMIM: PORT_RM020001UV01 and HMD: PORT_HD020001UV01 |
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| AnnotatedECG | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: This is a diagram comment on "AnnotatedECG.classCode". |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] Act (II) |
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| code [1..1] (M) Act (CV) {CWE:D:ActCode} |
Design Comments: LOINC code for ECG |
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| text [0..1] Act (ED) |
Design Comments: Alternate textual or multimedia representation of the annotated ECG. |
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| effectiveTime [1..1] (M) Act (IVL<TS>) |
Design Comments: Physiologically relevant time range assigned to ECG findings derived from the annotated ECG data contained herein. This time rnage should span the range of timestamps in the statistical dataset records containing the ECG findings derived from the ECG waveforms. |
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| confidentialityCode [0..1] Act (CD) {CWE:D:Confidentiality} |
Design Comments: blinded status of all data about this ECG |
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| reasonCode [0..1] Act (CD) {CWE:D:ActReason} |
Design Comments: per protocol, in protocol-wrong study event, not in protocol |
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| location [0..1] (Location1) | |||||||||
| definition [0..1] (Definition1) | |||||||||
| controlVariable [0..*] (ControlVariable1) | |||||||||
| component [0..*] (Component5) | |||||||||
| pertainsTo [0..*] (PertinentInformation) | |||||||||
| componentOf [1..1] (Component2) | |||||||||
| Location1 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetLocation, root= "LOC"} |
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| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "OP"} |
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| testingSite [1..1] (TestingSite) | |||||||||
| TestingSite | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassServiceDeliveryLocation, root= "SDLOC"} |
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| id [0..1] Role (II) |
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| location [0..1] (Location) | |||||||||
| Definition1 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipInstantiatesMaster, root= "INST"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:D:ContextControl, default= "AP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "false"} |
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| relativeTimepoint [1..1] (RelativeTimepoint) | |||||||||
| RelativeTimepoint | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| code [1..1] Act (CV) {CWE:D:ActCode} |
Design Comments: protocol specified code and name for study event |
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| componentOf [1..1] (Component3) | |||||||||
| Component3 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| pauseQuantity [0..1] ActRelationship (PQ) |
Design Comments: time elapsed since the referenceEvent for the same protocolTimepoint |
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| protocolTimepointEvent [1..1] (ProtocolTimepointEvent) | |||||||||
| ProtocolTimepointEvent | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassClinicalTrialTimepointEvent, root= "CTTEVENT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| code [1..1] Act (CV) {CWE:D:ActCode} |
Design Comments: code and name for planned timepoint |
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| component [1..1] (Component4) | |||||||||
| Component4 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| referenceEvent [1..1] (ReferenceEvent) | |||||||||
| ReferenceEvent | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| code [1..1] Act (CV) {CWE:D:ActCode} |
Design Comments: protocol specified code and name for reference event |
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| ControlVariable1 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:D:ContextControl, default= "AP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| relatedObservation [1..1] (RelatedObservation) | |||||||||
| RelatedObservation | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
Design Comments: differentiates types of observations |
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| text [0..1] Act (ED) |
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| value [0..1] Observation (ANY) |
Design Comments: contains content or value for the type of observation specified in "code" |
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| author [0..*] (Author4) | |||||||||
| Author4 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| AssignedEntity | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"} |
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| id [0..1] Role (II) |
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| assignedAuthorType [0..1] (AuthorType) | |||||||||
| representedAuthoringOrganization [0..1] (AuthoringOrganization) | |||||||||
| AuthorType | |||||||||
| choice of Person | |||||||||
| or Device | |||||||||
| Device | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassDevice, root= "DEV"} |
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| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| id [0..*] Entity (DSET<II>) |
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| code [0..1] Entity (CD) {CWE:D:EntityCode} |
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| manufacturerModelName [0..1] Device (SC) |
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| softwareName [0..1] Device (SC) |
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| asManufacturedDevice [0..1] (ManufacturedDevice) | |||||||||
| ManufacturedDevice | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassManufacturedProduct, root= "MANU"} |
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| manufacturerOrganization [0..1] (Organization) | |||||||||
| AuthoringOrganization | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| id [0..1] Entity (II) |
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| name [0..1] Entity (ON) |
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| asIdentifiedEntity [0..1] (IdentifiedEntity) | |||||||||
| IdentifiedEntity | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassIdentifiedEntity, root= "IDENT"} |
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| id [0..1] Role (II) |
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| Component5 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| series [1..1] (Series) | |||||||||
| Series | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservationSeries, root= "OBSSER"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [0..1] Act (II) |
Design Comments: Optional ID of the series. |
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| code [1..1] Act (CD) {CWE:V:ECGObservationSeriesType} |
Design Comments: Code for "rhythm waveforms" or "representative beat". |
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| effectiveTime [1..1] Act (IVL<TS>) |
Design Comments: Date/time when the data was collected from the subject. |
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| secondaryPerformer [0..*] (SecondaryPerformer) | |||||||||
| author [0..1] (Author1) | |||||||||
| support [0..1] (Support2) | |||||||||
| controlVariable [0..*] (ControlVariable6) | |||||||||
| component [1..*] (Component8) | |||||||||
| subjectOf [0..*] (Subject2) | |||||||||
| derivation [0..*] (DerivedFrom) | |||||||||
| SecondaryPerformer | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationSecondaryPerformer, root= "SPRF"} |
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| functionCode [0..1] Participation (CD) {CWE:D:ParticipationFunction} |
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| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "OP"} |
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| time [0..1] Participation (IVL<TS>) |
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| seriesPerformer [1..1] (SeriesPerformer) | |||||||||
| SeriesPerformer | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"} |
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| id [0..1] Role (II) |
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| assignedPerson [0..1] (Person) | |||||||||
| Author1 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "OP"} |
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| seriesAuthor [1..1] (SeriesAuthor) | |||||||||
| SeriesAuthor | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassManufacturedProduct, root= "MANU"} |
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| id [0..1] Role (II) |
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| manufacturedSeriesDevice [1..1] (SeriesDevice) | |||||||||
| manufacturerOrganization [0..1] (Organization) | |||||||||
| SeriesDevice | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassDevice, root= "DEV"} |
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| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| id [0..*] Entity (DSET<II>) |
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| code [0..1] Entity (CD) {CWE:D:EntityCode} |
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| manufacturerModelName [0..1] Device (SC) |
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| softwareName [0..1] Device (SC) |
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| Support2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSupport, root= "SPRT"} |
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| rOI [1..1] (ROI) | |||||||||
| ROI | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassBoundedRoi, root= "ROIBND"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [1..1] Act (CD) {CWE:V:ActBoundedROICode} |
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| component [1..*] (Component7) | |||||||||
| Component7 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| boundary [1..1] (Boundary) | |||||||||
| Boundary | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [1..1] Act (CD) {CWE:D:ECGObservationSequenceType} |
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| value [0..1] Observation (ANY) |
Design Comments: Boundary specification, usually as an interval. |
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| ControlVariable6 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
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| controlVariable [1..1] (ControlVariable) | |||||||||
| ControlVariable | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [1..1] Act (CD) {CWE:D:ECGControlVariable} |
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| value [0..1] Observation (ANY) |
Design Comments: Value of device setting, etc. |
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| component [0..*] (Component12) | |||||||||
| Component12 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| controlVariable [1..1] (ControlVariable) | |||||||||
| Component8 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| sequenceSet [1..1] (SequenceSet) | |||||||||
| SequenceSet | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassCorrelatedObservationSequences, root= "OBSCOR"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| controlVariable [0..*] (ControlVariable5) | |||||||||
| component [1..*] (Component9) | |||||||||
| ControlVariable5 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
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| controlVariable [1..1] (ControlVariable) | |||||||||
| Component9 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| sequence [1..1] (Sequence) | |||||||||
| Sequence | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [1..1] Act (CD) {CWE:D:ECGObservationSequenceType} |
Design Comments: Code for "absolute time", "relative time", or an ECG Lead. |
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| value [1..1] Observation (ANY) |
Design Comments: Sequence's generated or enumerated values. |
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| controlVariable [0..*] (ControlVariable3) | |||||||||
| ControlVariable3 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
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| controlVariable [1..1] (ControlVariable) | |||||||||
| Subject2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
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| annotationSet [1..1] (AnnotationSet) | |||||||||
| AnnotationSet | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [0..1] Act (CD) {CWE:D:ECGAnnotationType} |
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| activityTime [0..1] Act (QSET<TS>) |
Design Comments: When set of annotations was made. |
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| methodCode [0..*] Observation (DSET<CD>) {CWE:D:ObservationMethod} |
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| author [0..*] (Author2) | |||||||||
| controlVariable [0..*] (ControlVariable4) | |||||||||
| component [0..*] (Component) | |||||||||
| Author2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "OP"} |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| ControlVariable4 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
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| controlVariable [1..1] (ControlVariable) | |||||||||
| Component | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| annotation [1..1] (Annotation) | |||||||||
| Annotation | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [1..1] Act (CD) {CWE:D:ECGAnnotationType} |
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| text [0..1] Act (ED) |
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| value [0..1] Observation (ANY) |
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| support [0..1] (Support1) | |||||||||
| component [0..*] (Component6) | |||||||||
| Support1 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSupport, root= "SPRT"} |
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| rOI [1..1] (ROI) | |||||||||
| Component6 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:D:ContextControl, default= "OP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| sequenceNumber [0..1] ActRelationship (INT) |
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| annotation [1..1] (Annotation) | |||||||||
| DerivedFrom | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipIsDerivedFrom, root= "DRIV"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:D:ContextControl, default= "OP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| series [1..1] (Series) | |||||||||
| PertinentInformation | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:D:ContextControl, default= "OP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| findingComment [1..1] (FindingComment) | |||||||||
| FindingComment | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| text [0..1] Act (ED) |
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| value [0..1] Observation (ST) |
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| author [0..*] (Author) | |||||||||
| Author | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| Component2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| timepointEvent [1..1] (TimepointEvent) | |||||||||
| TimepointEvent | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassClinicalTrialTimepointEvent, root= "CTTEVENT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [0..1] Act (CV) {CWE:D:ActCode} |
Design Comments: protocol code and name for the study event - visit number, study day, etc. |
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| effectiveTime [0..1] Act (IVL<TS>) |
Design Comments: time period of subject's participation in the study event |
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| reasonCode [0..*] Act (DSET<CD>) {CWE:D:ActReason} |
Design Comments: scheduled, unscheduled, retest, early termination |
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| performer [0..1] (Performer2) | |||||||||
| componentOf [1..1] (Component1) | |||||||||
| Performer2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationPhysicalPerformer, root= "PRF"} |
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| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "OP"} |
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| studyEventPerformer [1..1] (StudyEventPerformer) | |||||||||
| StudyEventPerformer | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"} |
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| id [0..1] Role (II) |
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| assignedPerson [0..1] (Person) | |||||||||
| Person | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassPerson, root= "PSN"} |
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| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..1] Entity (PN) |
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| Component1 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| subjectAssignment [1..1] (SubjectAssignment) | |||||||||
| SubjectAssignment | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| subject [1..1] (Subject1) | |||||||||
| definition [0..1] (Definition3) | |||||||||
| componentOf [1..1] (Component10) | |||||||||
| Subject1 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
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| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "OP"} |
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| trialSubject [1..1] (TrialSubject) | |||||||||
| TrialSubject | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassResearchSubject, root= "RESBJ"} |
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| id [1..1] Role (II) |
Design Comments: Subject ID |
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| code [0..1] Role (CV) {CWE:D:ResearchSubjectRoleBasis} |
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| subjectDemographicPerson [0..1] (DemographicPerson) | |||||||||
| DemographicPerson | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassPerson, root= "PSN"} |
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| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..1] Entity (PN) |
Design Comments: Subject name or initials. |
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| administrativeGenderCode [0..1] LivingSubject (CD) {CWE:D:AdministrativeGender} |
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| birthTime [0..1] LivingSubject (TS) |
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| raceCode [0..1] Person (CV) {CWE:D:Race} |
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| Definition3 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipInstantiatesMaster, root= "INST"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:D:ContextControl, default= "OP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "false"} |
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| treatmentGroupAssignment [1..1] (TreatmentGroupAssignment) | |||||||||
| TreatmentGroupAssignment | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassSubstanceAdministration, root= "SBADM"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| code [1..1] Act (CV) {CWE:D:ActCode} |
Design Comments: Code and name of the treatment group. |
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| Component10 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| clinicalTrial [1..1] (ClinicalTrial) | |||||||||
| ClinicalTrial | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] Act (II) |
Design Comments: Put traditional trial identifier into "extension". |
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| title [0..1] Act (ST) |
Design Comments: The name or title of the trial. |
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| activityTime [0..1] Act (IVL<TS>) |
Design Comments: actual start/end dateTimes for this trial of the protocol or component thereof |
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| responsibleParty [0..*] (ResponsibleParty) | |||||||||
| author [0..1] (Author3) | |||||||||
| location [0..*] (Location2) | |||||||||
| componentOf [0..1] (Component11) | |||||||||
| ResponsibleParty | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationResponsibleParty, root= "RESP"} |
|||||||||
| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "AP"} |
|||||||||
| trialInvestigator [1..1] (TrialInvestigator) | |||||||||
| TrialInvestigator | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassClinicalResearchInvestigator, root= "CRINV"} |
|||||||||
| id [1..1] Role (II) |
|||||||||
| investigatorPerson [0..1] (Person) | |||||||||
| Author3 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
|||||||||
| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "AP"} |
|||||||||
| clinicalTrialSponsor [1..1] (ClinicalTrialSponsor) | |||||||||
| ClinicalTrialSponsor | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassClinicalResearchSponsor, root= "CRSPNSR"} |
|||||||||
| sponsorOrganization [1..1] (Organization) | |||||||||
| Organization | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
|||||||||
| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
|||||||||
| id [0..1] Entity (II) |
|||||||||
| name [0..1] Entity (ON) |
|||||||||
| Location2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetLocation, root= "LOC"} |
|||||||||
| contextControlCode [0..1] Participation (CS) {CNE:D:ContextControl, default= "AP"} |
|||||||||
| trialSite [1..1] (TrialSite) | |||||||||
| TrialSite | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassServiceDeliveryLocation, root= "SDLOC"} |
|||||||||
| id [1..1] Role (II) |
|||||||||
| location [0..1] (Location) | |||||||||
| Location | |||||||||
| classCode [1..1] (M) Entity (CS) {CNE:V:EntityClassPlace, root= "PLC"} |
|||||||||
| determinerCode [1..1] (M) Entity (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
|||||||||
| name [0..1] Entity (TN) |
|||||||||
| addr [0..1] Place (AD) |
Design Comments: Specify country as a minimum. |
||||||||
| Component11 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
|||||||||
| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
|||||||||
| clinicalTrialProtocol [1..1] (ClinicalTrialProtocol) | |||||||||
| ClinicalTrialProtocol | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
|||||||||
| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
|||||||||
| id [1..1] Act (II) |
Design Comments: Put traditional protocol identifier into "extension". |
||||||||
| title [0..1] Act (ST) |
Design Comments: The name or title of the protocol. |
||||||||