| PORT_HD090002UV01 StabilityStudySubmission |
(Link to Excel View) Derived from RMIM: PORT_RM090002UV01 |
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| StabilityStudy | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"} |
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| id [1..1] (M) Act (II) |
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| code [1..1] (M) Act (CD) {CWE:D:ActCode} |
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| text [0..1] Act (ED) |
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| reasonCode [0..1] Act (CD) {CWE:D:ActReason} |
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| subject [1..1] (Subject1) | |||||||||
| component [1..1] (Component5) | |||||||||
| componentOf [0..*] (Component) | |||||||||
| Subject1 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:C:ParticipationType:SBJ, fixed value= "SBJ"} |
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| researchSubject [1..1] (ResearchSubject) | |||||||||
| ResearchSubject | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:RESBJ, fixed value= "RESBJ"} |
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| subjectSpecifiedSubstanceOrProduct [1..1] (SpecifiedSubstanceOrProduct) | |||||||||
| researchSponsor [0..1] (StudySponsor) | |||||||||
| subjectOf [1..1] (Subject3) | |||||||||
| SpecifiedSubstanceOrProduct | |||||||||
| choice of Substance | |||||||||
| or Product | |||||||||
| Substance | |||||||||
| classCode [1..1] (M) ManufacturedMaterial (CS) {CNE:C:EntityClass:MMAT, fixed value= "MMAT"} |
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| determinerCode [1..1] (M) ManufacturedMaterial (CS) {CNE:C:EntityDeterminer:EntityDeterminer, fixed value= "EntityDeterminer"} |
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| code [1..1] (M) ManufacturedMaterial (CD) {CWE:D:EntityCode} |
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| desc [0..1] ManufacturedMaterial (ED) |
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| expirationTime [1..1] ManufacturedMaterial (IVL<TS>) |
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| Product | |||||||||
| classCode [1..1] (M) ManufacturedMaterial (CS) {CNE:C:EntityClass:MMAT, fixed value= "MMAT"} |
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| determinerCode [1..1] (M) ManufacturedMaterial (CS) {CNE:C:EntityDeterminer:KIND, fixed value= "KIND"} |
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| code [1..1] (M) ManufacturedMaterial (CD) {CWE:D:EntityCode} |
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| desc [0..1] ManufacturedMaterial (ED) |
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| formCode [1..1] (M) ManufacturedMaterial (CD) {CWE:D:MaterialForm} |
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| expirationTime [1..1] ManufacturedMaterial (IVL<TS>) |
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| specifiedIngredient [0..*] (SpecifiedIngredient) | |||||||||
| SpecifiedIngredient | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:INGR, fixed value= "INGR"} |
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| quantity [1..1] Role (RTO<PQ,PQ>) |
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| ingredientSubstance [1..1] (Substance) | |||||||||
| StudySponsor | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:C:EntityClass:ORG, fixed value= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"} |
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| id [0..*] Organization (DSET<II>) |
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| name [0..1] Organization (ON) |
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| addr [0..1] Organization (AD) |
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| Subject3 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:C:ParticipationType:SBJ, fixed value= "SBJ"} |
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| specification [1..1] (Specification) | |||||||||
| Specification | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"} |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
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| text [0..1] Observation (ED) |
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| component [0..*] (Component6) | |||||||||
| Component6 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| testDefinition [1..1] (TestDefinition) |
Design Comments: AKA Method |
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| TestDefinition |
Design Comments: AKA Method |
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| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"} |
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| id [1..1] (M) Observation (II) |
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| code [1..1] Observation (CD) {CWE:D:ActCode} |
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| text [0..1] Observation (ED) |
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| methodCode [0..1] Observation (CD) {CWE:D:ObservationMethod} |
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| referenceRange [0..*] (ReferenceRange) | |||||||||
| component [0..*] (Component7) | |||||||||
| ReferenceRange | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:REFV, fixed value= "REFV"} |
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| acceptanceCriterion [1..1] (AcceptanceCriterion) | |||||||||
| AcceptanceCriterion | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:EVN.CRT, fixed value= "EVN.CRT"} |
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| negationInd [0..1] Observation (BL){default= "false"} |
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| text [0..1] Observation (ST) |
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| value [1..1] (M) Observation (ANY) {CWE:D:ObservationValue} |
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| interpretationCode [1..1] (M) Observation (CV) {CWE:V:ObservationInterpretation, default= "N"} |
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| Component7 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| testDefinition [1..1] (TestDefinition) | |||||||||
| Component5 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| studyOnBatch [1..1] (StudyOnBatch) | |||||||||
| StudyOnBatch | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"} |
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| id [1..1] Act (II) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| subject [1..1] (Subject2) | |||||||||
| component1 [1..*] (Component3) | |||||||||
| component2 [1..1] (Component4) | |||||||||
| Subject2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:C:ParticipationType:SBJ, fixed value= "SBJ"} |
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| instance [1..1] (Instance) | |||||||||
| Instance | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:INST, fixed value= "INST"} |
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| manufacturedMaterialInstance [1..1] (ManufacturedMaterial) |
Design Comments: Product or Substance Manufactured Instance |
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| ManufacturedMaterial |
Design Comments: Product or Substance Manufactured Instance |
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| classCode [1..1] (M) ManufacturedMaterial (CS) {CNE:C:EntityClass:MMAT, fixed value= "MMAT"} |
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| determinerCode [1..1] (M) ManufacturedMaterial (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"} |
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| quantity [0..1] ManufacturedMaterial (PQ) |
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| desc [0..1] ManufacturedMaterial (ED) |
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| existenceTime [1..1] ManufacturedMaterial (IVL<TS>) |
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| lotNumberText [1..1] ManufacturedMaterial (ST.SIMPLE) |
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| expirationTime [0..1] ManufacturedMaterial (IVL<TS>) |
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| asManufacturedProduct [1..1] (ManufacturedProduct) | |||||||||
| asContent [1..1] (Content) | |||||||||
| batchIngredient [0..*] (BatchIngredient) | |||||||||
| ManufacturedProduct | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:MANU, fixed value= "MANU"} |
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| manufacturer [1..1] (Manufacturer) | |||||||||
| Manufacturer | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:C:EntityClass:ORG, fixed value= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"} |
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| id [0..*] Organization (DSET<II>) |
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| name [1..1] Organization (ON) |
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| addr [0..1] Organization (AD) |
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| assignedEntity [0..*] (AssignedEntity2) | |||||||||
| AssignedEntity2 | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:ASSIGNED, fixed value= "ASSIGNED"} |
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| representedManufacturer [1..1] (Manufacturer) | |||||||||
| Content | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:CONT, fixed value= "CONT"} |
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| quantity [0..1] Role (RTO<PQ,PQ>) |
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| container [1..1] (Container) | |||||||||
| Container | |||||||||
| classCode [1..1] (M) Container (CS) {CNE:C:EntityClass:CONT, fixed value= "CONT"} |
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| determinerCode [1..1] (M) Container (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"} |
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| code [0..1] Container (CD) {CWE:D:EntityCode} |
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| desc [0..1] Container (ED) |
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| lotNumberText [0..1] Container (ST.SIMPLE) |
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| capacityQuantity [1..1] Container (PQ) |
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| capTypeCode [0..1] Container (CD) {CWE:D:ContainerCap} |
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| BatchIngredient | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:INGR, fixed value= "INGR"} |
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| quantity [0..1] Role (RTO<PQ,PQ>) |
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| ingredientManufacturedMaterial [1..1] (ManufacturedMaterial) | |||||||||
| Component3 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| pauseQuantity [1..1] (M) ActRelationship (PQ.TIME) |
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| testing [1..1] (Testing) | |||||||||
| Testing | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"} |
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| code [1..1] (M) Observation (CD) {CWE:D:ActCode} |
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| title [1..1] (M) Observation (ST) |
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| text [0..1] Observation (ED) |
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| effectiveTime [0..1] Observation (IVL<TS>) |
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| performer [1..*] (Performer1) | |||||||||
| component [0..*] (Component1) | |||||||||
| Performer1 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:C:ParticipationType:PRF, fixed value= "PRF"} |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| AssignedEntity | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:ASSIGNED, fixed value= "ASSIGNED"} |
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| assignedTestingSite [1..1] (TestingSite) |
Design Comments: AKA Test Performing Organization |
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| TestingSite |
Design Comments: AKA Test Performing Organization |
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| classCode [1..1] (M) Organization (CS) {CNE:C:EntityClass:ORG, fixed value= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"} |
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| id [0..*] Organization (DSET<II>) |
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| name [0..1] Organization (ON) |
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| addr [0..1] Organization (AD) |
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| Component1 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| test [1..1] (Test) |
Design Comments: AKA Result |
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| Test |
Design Comments: AKA Result |
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| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"} |
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| title [0..1] Observation (ED) |
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| text [0..1] Observation (ED) |
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| effectiveTime [1..1] (M) Observation (IVL<TS>) |
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| value [1..1] (M) Observation (ANY) {CWE:D:ObservationValue} |
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| performer [1..1] (Performer2) | |||||||||
| definition [0..1] (Definition) | |||||||||
| component [0..*] (Component2) | |||||||||
| Performer2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationPhysicalPerformer, root= "PRF"} |
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| assignedEntityStub [1..1] (AssignedEntityStub) | |||||||||
| AssignedEntityStub | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:C:RoleClass:ASSIGNED, fixed value= "ASSIGNED"} |
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| assignedSiteStub [1..1] (SiteStub) | |||||||||
| SiteStub | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:C:EntityClass:ORG, fixed value= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"} |
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| id [0..*] Organization (DSET<II>) |
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| Definition | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:INST, fixed value= "INST"} |
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| definitionStub [1..1] (DefinitionStub) | |||||||||
| DefinitionStub | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"} |
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| id [1..1] (M) Observation (II) |
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| Component2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| sequenceNumber [0..1] ActRelationship (INT.NONNEG) |
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| pauseQuantity [0..1] ActRelationship (PQ.TIME) |
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| test [1..1] (Test) | |||||||||
| Component4 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"} |
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| storage [1..1] (Storage) | |||||||||
| Storage | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"} |
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| code [1..1] (M) Act (CD) {CWE:D:ActCode} |
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| text [0..1] Act (ED) |
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| effectiveTime [0..1] Act (IVL<TS>) |
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| controlVariable [1..*] (ControlVariable) | |||||||||
| ControlVariable | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:C:ActRelationshipType:CTRLV, fixed value= "CTRLV"} |
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| storageCondition [1..1] (StorageCondition) | |||||||||
| StorageCondition | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:C:ActMood:EVN.CRT, fixed value= "EVN.CRT"} |
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| code [1..1] (M) Observation (CD) {CWE:D:ActCode} |
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| text [0..1] Observation (ED) |
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| value [1..1] (M) Observation (ANY) {CWE:D:ObservationValue} |
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| Component | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| sequenceNumber [0..1] ActRelationship (INT.NONNEG) |
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| associatedStudy [1..1] (AssociatedStudy) | |||||||||
| AssociatedStudy | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"} |
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| id [1..1] (M) Act (II) |
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| text [0..1] Act (ED) |
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