| PORR_HD049016UV01 HumanPharmaceuticalsBaseRMIM |
(Link to Excel View) Derived from RMIM: PORR_RM049016UV01 |
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| InvestigationEvent |
Design Comments: The InvestigationEvent serves as the entry point for the messaging model. The investigation class captures information directly related to the investigation and pulls together the rest of the relevant information. The investigation is always associated with a product for which an adverse event or product defect has been observed or suspected. Depending on the situation, this suspected event or problem may or may not have led to a reaction suffered by the investigative subject(s). Note that the attributes associated with an investigation are captured within the InvestigationEvent class in the RMIM. Specifically, effectiveTime is used to record the date and time during which the investigation took place, while the availabilityTime is used to record the date and time for the most recent information about the case. The date that the report is transmitted between interested parties is captured within the Control Act structure. UsageNotes: Concept Domain revision needed |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassInvestigation, root= "INVSTG"} |
Design Comments: The value, INVSTG, indicates the act is an investigation. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [1..*] Observation (DSET<II>) |
Design Comments: An identifier, provided by the report sender that uniquely identifies this adverse event or product problem report. Its value will be used to provide linkage when revised reports (aka followup) are sent, or when a report is withdrawn. Note, multiple identifiers are supported. |
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| code [1..1] (M) Observation (CD) {CWE:D:IndividualCaseSafetyReportType} |
Design Comments: Act.code is used here to capture information to indicate that the report is an individual case safety report. Other relevant information used to type the report, or to provide administrative information needed by report receivers is included in the Investigation Characteristic class. |
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| text [0..1] Observation (ED) |
Design Comments: The attribute can be used to include a narrative summary of the investigation into, and conclusions from the product problem or adverse event. |
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| statusCode [1..1] Observation (CS) {CNE:V:ActStatus} |
Design Comments: A coded indication of the state of the investigation. It is used to indicate whether the investigation is ongoing or has been concluded. |
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| effectiveTime [0..1] Observation (IVL<TS>) |
Design Comments: Indicates the date at which the responsible party started its investigation, as well as the date on which the investigation completed. |
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| availabilityTime [0..1] Observation (TS) |
Design Comments: Provides information on the date/time of the most recent information collected during the investigation. |
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| reference [0..*] (Reference) |
Design Comments: Associates documents assigned to the ICSR with the investigation, which is considered the target of the document. |
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| component [0..*] (Component3) |
Design Comments: The act relationship makes it possible to link investigation components to the core investigation. |
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| outboundRelationship [0..*] (SourceOf) |
Design Comments: The act relationship makes it possible to take note of additional investigations that are related to the core investigation for the ICSR. |
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| subjectOf1 [0..*] (Subject9) |
Design Comments: Indicates that the target act is the subject of the source act. |
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| subjectOf2 [0..*] (Subject10) |
Design Comments: Makes it possible to relate an investigation to observations that provide information about characteristics of the investigation. |
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| Reference |
Design Comments: Associates documents assigned to the ICSR with the investigation, which is considered the target of the document. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipRefersTo, root= "REFR"} |
Design Comments: The value, REFR, indicates that the content of the document provides a reference for the investigation. |
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| document [1..1] (Document) |
Design Comments: This class captures primary source or other reference documents and/or literature references that the reporter or sender determines relevant to the investigation and should be considered part of the report. |
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| Document |
Design Comments: This class captures primary source or other reference documents and/or literature references that the reporter or sender determines relevant to the investigation and should be considered part of the report. |
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| classCode [1..1] (M) Document (CS) {CNE:V:ActClassDocument, root= "DOC"} |
Design Comments: The value provided, DOC, indicates that document information is being passed. |
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| moodCode [1..1] (M) Document (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| code [0..1] Document (CD) {CWE:D:ActICSRDocumentType} |
Design Comments: The code provides information about the type of document, e.g., autopsy report. |
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| title [0..1] Document (ST) |
Design Comments: A text title for the document |
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| text [0..1] Document (ED) |
Design Comments: The content of the document. This attribute can be used to provide a document's text or other content. It also supports a URL for the document. |
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| bibliographicDesignationText [0..1] Document (ED) |
Design Comments: Allows a bibliographic designation to be furnished so that report receivers can refer appropriately to the cited document. |
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| participation [0..1] (Participant2) |
Design Comments: In formation related to persons or organizations who participate in the creation or management of the document. |
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| Participant2 |
Design Comments: In formation related to persons or organizations who participate in the creation or management of the document. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationParticipation, root= "PART"} |
Design Comments: The value, PART, indicates that information related to entities who participate in creation or management of the document may be recorded. |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| Component3 |
Design Comments: The act relationship makes it possible to link investigation components to the core investigation. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
Design Comments: The value, COMP, indciates that the target act is a component of the source act. |
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| contextConductionInd [0..1] ActRelationship (BL) |
Design Comments: An indicator determining whether associations in the parent act are to be conducted across the ActRelationship to the child act. |
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| investigationComponent [1..1] (InvestigationComponent) | |||||||||
| InvestigationComponent | |||||||||
| author [0..1] (Author1) |
Design Comments: Information related to the author of an adverse event or product problem assessement, or of an observation related to the assessement or investigation. |
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| component1 [0..*] (Component2) |
Design Comments: The act relationship makes it possible to record observations that are a component of the source observation. |
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| choice of InvestigationAssessment | |||||||||
| or ObservationEvent |
Design Comments: An observation that is recorded as a component of the investigation. |
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| Author1 |
Design Comments: Information related to the author of an adverse event or product problem assessement, or of an observation related to the assessement or investigation. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: The value, AUT, indicates that information about the author of an act may be provided. |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| Component2 |
Design Comments: The act relationship makes it possible to record observations that are a component of the source observation. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
Design Comments: The value, COMP, indciates that the target act is a component of the source act. |
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| observationEvent [1..1] (ObservationEvent) | |||||||||
| InvestigationAssessment | |||||||||
| component [0..*] (Component1) |
Design Comments: The act relationship links causality assessements to the product defect or adverse event assessement of which they are a component. |
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| choice of AdverseEventAssessment |
Design Comments: This component is created for each adverse event that is being looked into within the context of an investigation. In the usual case there is a single event; however there may be multiple reactions - adverse occurrances - associated with a single event. |
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| Inherits associations from InvestigationComponent | |||||||||
| Component1 |
Design Comments: The act relationship links causality assessements to the product defect or adverse event assessement of which they are a component. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
Design Comments: The value, COMP, indciates that the target act is a component of the source act. |
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| causalityAssessment [1..1] (CausalityAssessment) |
Design Comments: This class captures the assessment of the relatedness between an act and the reaction suffered by the investigative subject. That is to say it records judgments made by the person indicated as the author or act performer about the extent to which an intervention caused a particular reaction. The primary use for this class is to record the investigator’s judgment regarding which of the acts concurrently performed or taking place is responsible for the outcome. However, it can also be used to evaluate the role of underlying conditions or disease states. These acts should also be recorded within the Product Reporting Related Information CMET that is associated with the investigative subject. In addition, the class is used to capture the reporte's (or sender's) evaluation as to whether the use of a product is suspect (or interacting) as a cause for an adverse event. |
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| CausalityAssessment |
Design Comments: This class captures the assessment of the relatedness between an act and the reaction suffered by the investigative subject. That is to say it records judgments made by the person indicated as the author or act performer about the extent to which an intervention caused a particular reaction. The primary use for this class is to record the investigator’s judgment regarding which of the acts concurrently performed or taking place is responsible for the outcome. However, it can also be used to evaluate the role of underlying conditions or disease states. These acts should also be recorded within the Product Reporting Related Information CMET that is associated with the investigative subject. In addition, the class is used to capture the reporte's (or sender's) evaluation as to whether the use of a product is suspect (or interacting) as a cause for an adverse event. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: The value provided, OBS, indicates that observation information is being passed. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| code [0..1] Observation (CD) {CWE:D:ObservationCausalityAssessmentType} |
Design Comments: A coded value that indicates the nature of the causality assessment, e.g., reaction relatedness, intervention characterization. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: Provides information on the actual relatedness (extent or existence of a relationship) between the reaction and the associated act. |
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| methodCode [0..*] Observation (DSET<CD>) {CWE:V:x_AdverseEventCausalityAssessmentMethods} |
Design Comments: Allows the responsible party to indicate the method by which the causality assessment was reached. |
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| author [0..*] (Author2) |
Design Comments: Indicates the author of a causality assessment. |
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| subject1 [0..1] (Subject3) |
Design Comments: Links the causality assessment to the information which has been recorded for adverse effect or effects. |
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| subject2 [0..1] (Subject11) |
Design Comments: Links the causality assessment to the use of a product (e.g., administration of a drug) which may have a causal relationship to an adverse event. |
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| Author2 |
Design Comments: Indicates the author of a causality assessment. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: The value, AUT, indicates that the entity participating in the indicated role is the author of the act. |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| AssignedEntity | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"} |
Design Comments: The value, ASSIGNED, indicates an entity that carries out activities as assigned by another entity. |
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| code [0..1] Role (CD) {CWE:D:ICSRReportingRoleType} |
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| addr [0..*] Role (COLL<AD>) |
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| telecom [0..*] Role (LIST<TEL>) |
Design Comments: One or more telecommunication addresses for the organization. Note, this includes phone numbers, fax numbers, and email addresses. |
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| assignedPerson [0..1] (Person) | |||||||||
| representedOrganization [0..1] (Organization) | |||||||||
| Subject3 |
Design Comments: Links the causality assessment to the information which has been recorded for adverse effect or effects. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
Design Comments: The value, SBJ, indicates a act has another as a subject. |
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| adverseEffectReference [1..1] (AdverseEffectReference) | |||||||||
| Subject11 |
Design Comments: Links the causality assessment to the use of a product (e.g., administration of a drug) which may have a causal relationship to an adverse event. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
Design Comments: The value, SBJ, indicates a act has another as a subject. |
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| productUseReference [1..1] (ProductUseReference) | |||||||||
| ProductUseReference | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..*] Act (DSET<II>) |
Design Comments: An "internal" identifier for an act that contains information for an adverse event. The notion of an internal identifier is that the identifier is only expected to be used within the context of a single instance. |
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| AdverseEventAssessment |
Design Comments: This component is created for each adverse event that is being looked into within the context of an investigation. In the usual case there is a single event; however there may be multiple reactions - adverse occurrances - associated with a single event. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassInvestigation, root= "INVSTG"} |
Design Comments: The value, INVSTG, indicates the act is an investigation. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..1] Observation (II) |
Design Comments: An identifier for the adverse event assessment. |
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| code [0..1] Observation (CD) {CWE:D:ICSR_InvestigationAssessmentActType} |
Design Comments: The code value is used to indicate this is an adverse event assessment. |
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| text [0..1] Observation (ED) |
Design Comments: A text description of the assessment. |
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| subject1 [0..*] (Subject1) |
Design Comments: Links the assessment of an adverse event to information about the person or animal that the event occurred to. |
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| subject2 [0..*] (Subject2) | |||||||||
| Inherits associations from InvestigationAssessment | |||||||||
| Inherits associations from InvestigationComponent | |||||||||
| Subject1 |
Design Comments: Links the assessment of an adverse event to information about the person or animal that the event occurred to. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
Design Comments: The value, SBJ, indicates a act has an entity playing or scoping a role as its subject. |
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| primaryRole [1..1] (PrimaryRole) |
Design Comments: The role is played by the primary subject of the investigation, a person or animal which has experienced an adverse event. |
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| PrimaryRole |
Design Comments: The role is played by the primary subject of the investigation, a person or animal which has experienced an adverse event. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassICSRInvestigationSubject} |
Design Comments: The class code value indicates the type of role, e.g., patient, research subject, which is most appropriate for the subject of the investigation. |
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| id [0..*] Role (DSET<II>) |
Design Comments: An identifer for the subject as player of the indicated role. |
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| player1 [1..1] (InvestigationRelatedEntity) | |||||||||
| subjectOf1 [0..*] (Subject12) |
Design Comments: In those cases where the subject of an investigation is also the subject of a clinical trial (research study), this participation provides a linkage to the study related information. |
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| subjectOf2 [0..*] (Subject13) |
Design Comments: Indicates the subject of clinical or other information that has been collected in the course of the investigation, or that is being included to provide context for that investigation. |
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| InvestigationRelatedEntity | |||||||||
| asIdentifiedEntity [0..*] (IdentifiedEntity) | |||||||||
| role [0..*] (Role) |
Design Comments: The role captures the relationship between an entity who experiences an adverse event and a related entity for which information needs to be collected as an aspect of the investigation. The most typical case is that of a mother who used a drug that may have led to injury to a nursing infant or to a fetus. |
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| choice of Person2 |
Design Comments: Information for a person who is involved in an adverse event report, either as the subject or as a person related to the the subject. |
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| IdentifiedEntity | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassIdentifiedEntity, root= "IDENT"} |
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| id [0..*] Role (DSET<II>) |
Design Comments: An identifier which has been assigned to the entity. |
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| code [0..1] Role (CD) {CWE:D:IdentifiedEntityType} |
Design Comments: A coded indication of the type of identifier which has been assigned to the entity. |
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| assigningOrganization [0..1] (Organization) |
Design Comments: The class captures information about organizations that are associated with the investigation, with a component of the investigation, or with information related to the investigation. |
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| Organization |
Design Comments: The class captures information about organizations that are associated with the investigation, with a component of the investigation, or with information related to the investigation. |
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| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
Design Comments: The value provided, ORG, indicates that organization information is being passed. |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: The value provided, INSTANCE, indicates that the information provided refers to a specific, existing entity. |
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| name [0..1] Organization (ON) |
Design Comments: The text name of the organization. |
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| telecom [0..*] Organization (LIST<TEL>) |
Design Comments: One or more telecommunication addresses for the organization. Note, this includes phone numbers, fax numbers, and email addresses. |
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| addr [0..1] Organization (AD) |
Design Comments: A postal address for the organization. |
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| assignedEntity [0..1] (AssignedEntity2) |
Design Comments: Makes it possible to capture information about an organization which is assigned to perform tasks on behalf of another organization. This makes it possible to capture responsible department within the context of an organization providing ICSR reports (or which is otherwise involved in the adverse event or product problem investigation. |
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| asIdentifiedEntity [0..*] (IdentifiedEntity2) | |||||||||
| asLocatedEntity [0..*] (LocatedEntity) |
Design Comments: A role that makes it possible to indicate the place at which an organization is located. |
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| contactParty [0..*] (ContactParty) |
Design Comments: This role makes it possible to collect information about a contact person for an entity playing the role of author, performer, or recipient. The role is played by the contact person, and scoped by the party on whose behalf the person acts as contact. |
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| AssignedEntity2 |
Design Comments: Makes it possible to capture information about an organization which is assigned to perform tasks on behalf of another organization. This makes it possible to capture responsible department within the context of an organization providing ICSR reports (or which is otherwise involved in the adverse event or product problem investigation. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAssignedEntity, root= "ASSIGNED"} |
Design Comments: The value, ASSIGNED, indicates an entity that carries out activities as assigned by another entity. |
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| representedOrganization [0..1] (Organization) | |||||||||
| IdentifiedEntity2 | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassIdentifiedEntity, root= "IDENT"} |
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| id [0..*] Role (DSET<II>) |
Design Comments: An identifier which has been assigned to the entity. |
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| code [0..1] Role (CD) {CWE:D:IdentifiedEntityType} |
Design Comments: A coded indication of the type of identifier which has been assigned to the entity. |
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| assigningOrganization [0..1] (Organization) | |||||||||
| LocatedEntity |
Design Comments: A role that makes it possible to indicate the place at which an organization is located. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassLocatedEntity, root= "LOCE"} |
Design Comments: The value, LOCE, indicates that scoping entity will be the place at which the playing entity is located. |
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| location [0..1] (Place) |
Design Comments: A jurisdiction such as a country or state/province within which a reporting or report receiving party operates. |
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| Place |
Design Comments: A jurisdiction such as a country or state/province within which a reporting or report receiving party operates. |
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| classCode [1..1] (M) Place (CS) {CNE:V:EntityClassPlace, root= "PLC"} |
Design Comments: The, value, PLC, indicates that information for a place is being provided. Note, this value may be specialized to indicate whether a country, state or province, city or county is being referred to. |
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| determinerCode [1..1] (M) Place (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: The value provided, INSTANCE, indicates that the information provided refers to a specific, existing entity. |
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| code [0..1] Place (CD) {CWE:D:EntityCode} |
Design Comments: Used to identify the specific country, province, county or city, Which of these is being referred to is shown by the specialization of class code. |
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| name [0..1] Place (TN) |
Design Comments: A next name for the place. |
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| ContactParty |
Design Comments: This role makes it possible to collect information about a contact person for an entity playing the role of author, performer, or recipient. The role is played by the contact person, and scoped by the party on whose behalf the person acts as contact. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassContact, root= "CON"} |
Design Comments: The value, CON, indicates that the playing person acts as a contact for the scoping entity. |
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| addr [0..1] Role (AD) |
Design Comments: A postal address for contacting the person in their role as contact. |
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| telecom [0..*] Role (LIST<TEL>) |
Design Comments: One or more telecommunication addresses for the person. Note, this includes phone numbers, fax numbers, and email addresses. |
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| contactPerson [1..1] (Person) |
Design Comments: The class captures information about persons that are associated with the investigation, with a component of the investigation, or with information related to the investigation. |
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| Person |
Design Comments: The class captures information about persons that are associated with the investigation, with a component of the investigation, or with information related to the investigation. |
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| classCode [1..1] (M) Person (CS) {CNE:V:EntityClassPerson, root= "PSN"} |
Design Comments: The value provided,PSN, indicates that person information is being passed. |
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| determinerCode [1..1] (M) Person (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..1] Person (PN) |
Design Comments: The name of the person. |
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| asQualifiedEntity [0..*] (QualifiedEntity) |
Design Comments: Information about the professional or life role played by a person involved in the report (most notably as an author). |
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| asIdentifiedEntity [0..*] (IdentifiedEntity3) | |||||||||
| asLocatedEntity [0..*] (LocatedEntity2) |
Design Comments: A role that makes it possible to indicate the place at which an organization is located. |
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| contactParty [0..*] (ContactParty2) |
Design Comments: This role makes it possible to collect information about a contact person for an entity playing the role of author, performer, or recipient. The role is played by the contact person, and scoped by the party on whose behalf the person acts as contact. |
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| QualifiedEntity |
Design Comments: Information about the professional or life role played by a person involved in the report (most notably as an author). |
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| classCode [1..1] (M) QualifiedEntity (CS) {CNE:V:RoleClassQualifiedEntity, root= "QUAL"} |
Design Comments: The value, QUAL, indicates that the role will be used to provide information about the person's qualifications. |
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| code [0..1] QualifiedEntity (CD) {CWE:D:RoleCode} |
Design Comments: A coded value that provides informatin about the professional or other role played by the person, e.g., doctor, veterinarian. |
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| IdentifiedEntity3 | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassIdentifiedEntity, root= "IDENT"} |
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| id [0..*] Role (DSET<II>) |
Design Comments: An identifier which is assigned to the entity. |
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| code [0..1] Role (CD) {CWE:D:IdentifiedEntityType} |
Design Comments: A coded indication of the type of identifier which has been assigned to the entity. |
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| assigningOrganization [0..1] (Organization) | |||||||||
| LocatedEntity2 |
Design Comments: A role that makes it possible to indicate the place at which an organization is located. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassLocatedEntity, root= "LOCE"} |
Design Comments: The value, LOCE, indicates that scoping entity will be the place at which the playing entity is located. |
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| location [0..1] (Place) | |||||||||
| ContactParty2 |
Design Comments: This role makes it possible to collect information about a contact person for an entity playing the role of author, performer, or recipient. The role is played by the contact person, and scoped by the party on whose behalf the person acts as contact. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassContact, root= "CON"} |
Design Comments: The value, CON, indicates that the playing person acts as a contact for the scoping entity. |
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| addr [0..1] Role (AD) |
Design Comments: A postal address for contacting the person in their role as contact. |
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| telecom [0..*] Role (COLL<TEL>) |
Design Comments: One or more telecommunication addresses for the person. Note, this includes phone numbers, fax numbers, and email addresses. |
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| contactPerson [1..1] (Person) | |||||||||
| Role |
Design Comments: The role captures the relationship between an entity who experiences an adverse event and a related entity for which information needs to be collected as an aspect of the investigation. The most typical case is that of a mother who used a drug that may have led to injury to a nursing infant or to a fetus. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAssociative} |
Design Comments: The class code value indicates the general nature of the relationship between the two entities. |
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| code [0..1] Role (CD) {CWE:D:PersonalRelationshipRoleType} |
Design Comments: The code value indicates the nature of the relationship between the two entities, e.g., parent. |
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| associatedInvestigationRelatedEntity [1..1] (InvestigationRelatedEntity) | |||||||||
| subjectOf1 [0..*] (Subject) |
Design Comments: In those cases where the subject of an investigation is also the subject of a clinical trial (research study), this participation provides a linkage to the study related information. |
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| subjectOf2 [0..*] (Subject14) |
Design Comments: Indicates the subject of clinical or other information that has been collected in the course of the investigation, or that is being included to provide context for that investigation. |
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| Subject |
Design Comments: In those cases where the subject of an investigation is also the subject of a clinical trial (research study), this participation provides a linkage to the study related information. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
Design Comments: The value, SBJ, indicates a act has an entity playing or scoping a role as its subject. |
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| studyEnrollment [1..1] (StudyEnrollment) | |||||||||
| StudyEnrollment | |||||||||
| choice of ResearchStudy |
Design Comments: A study or clinical trial in which a subject of the investigation is enrolled. |
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| ResearchStudy |
Design Comments: A study or clinical trial in which a subject of the investigation is enrolled. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
Design Comments: the value, CLNTRL, indicates the act is a clinical trial. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..1] Observation (II) |
Design Comments: An identifier for the clinical trial. For the most part, this is the identifier assigned by the trial sponsor. |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
Design Comments: A coded indication of the nature of the clinical trial. |
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| title [0..1] Observation (ST) |
Design Comments: A text title for the trial. |
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| authorization [0..*] (Authorization) |
Design Comments: A link between the clinical trial and the act in which that trial was authorized by an appropriate authority. |
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| Authorization |
Design Comments: A link between the clinical trial and the act in which that trial was authorized by an appropriate authority. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipAuthorizedBy, root= "AUTH"} |
Design Comments: The value, AUTH, indicates that the target act has information pertinent to the authorization of the source act. |
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| studyRegistration [1..1] (StudyRegistration) |
Design Comments: Information to identify the study as authorized by a compentent authority. |
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| StudyRegistration |
Design Comments: Information to identify the study as authorized by a compentent authority. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
Design Comments: The value, ACT, indicates that an unspecialized act is taking place. |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..1] Act (II) |
Design Comments: An identifer for the study authorization. In many cases, this will be the identifier which the authorizing jurisdiction knows the study by. |
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| author [0..1] (Author4) |
Design Comments: Indicates the party responsible for registration of the study. |
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| Author4 |
Design Comments: Indicates the party responsible for registration of the study. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: The value, AUT, indicates that the entity participating in the indicated role is the author of the act. |
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| territorialAuthority [1..1] (TerritorialAuthority) |
Design Comments: A role whose player is an organization that holds authority over the scoping place within a particular context. |
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| TerritorialAuthority |
Design Comments: A role whose player is an organization that holds authority over the scoping place within a particular context. |
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| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassTerritoryOfAuthority, root= "TERR"} |
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| id [0..*] Role (DSET<II>) |
Design Comments: An identifier for the organization holding jurisdiction. |
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| governingPlace [0..1] (Place) | |||||||||
| Subject14 |
Design Comments: Indicates the subject of clinical or other information that has been collected in the course of the investigation, or that is being included to provide context for that investigation. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
Design Comments: The value, SBJ, indicates a act has an entity playing or scoping a role as its subject. |
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| humanPharmaceuticalsPRRIModel [1..1] (A_HumanPharmaceuticalsPRRIModelUniversal) | |||||||||
| Person2 |
Design Comments: Information for a person who is involved in an adverse event report, either as the subject or as a person related to the the subject. |
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| classCode [1..1] (M) Person (CS) {CNE:V:EntityClassPerson, root= "PSN"} |
Design Comments: The value provided,PSN, indicates that person information is being passed. |
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| determinerCode [1..1] (M) Person (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
Design Comments: The value provided, INSTANCE, indicates that the information provided refers to a specific, existing entity or collection of entities. |
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| name [0..*] Person (COLL<EN>) |
Design Comments: A text name for the person. |
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| telecom [0..*] Person (COLL<TEL>) |
Design Comments: One or more telecommunication addresses for the organization. Note, this includes phone numbers, fax numbers, and email addresses. |
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| administrativeGenderCode [0..1] Person (CD) {CWE:D:AdministrativeGender} |
Design Comments: The gender of the person. |
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| birthTime [0..1] Person (TS) |
Design Comments: The person's date of birth. |
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| deceasedInd [0..1] Person (BL) |
Design Comments: An indicator to show whether or not the person has died. |
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| deceasedTime [0..1] Person (TS) |
Design Comments: If the person is dead, the date and time of death. |
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| addr [0..*] Person (COLL<AD>) |
Design Comments: A postal address for the person. |
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| raceCode [0..*] Person (DSET<CD>) {CWE:D:Race} |
Design Comments: An indication of the person's race. |
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| Inherits associations from InvestigationRelatedEntity | |||||||||
| Subject12 |
Design Comments: In those cases where the subject of an investigation is also the subject of a clinical trial (research study), this participation provides a linkage to the study related information. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
Design Comments: The value, SBJ, indicates a act has an entity playing or scoping a role as its subject. |
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| studyEnrollment [1..1] (StudyEnrollment) | |||||||||
| Subject13 |
Design Comments: Indicates the subject of clinical or other information that has been collected in the course of the investigation, or that is being included to provide context for that investigation. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetSubject, root= "SBJ"} |
Design Comments: The value, SBJ, indicates a act has an entity playing or scoping a role as its subject. |
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| humanPharmaceuticalsPRRIModel [1..1] (A_HumanPharmaceuticalsPRRIModelUniversal) | |||||||||
| Subject2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
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| adverseEffectReference [1..1] (AdverseEffectReference) | |||||||||
| AdverseEffectReference | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..*] Act (DSET<II>) |
Design Comments: An "internal" identifier for an act that contains information for an adverse event. The notion of an internal identifier is that the identifier is only expected to be used within the context of a single instance. |
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| ObservationEvent |
Design Comments: An observation that is recorded as a component of the investigation. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: The value provided, OBS, indicates that observation information is being passed. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..1] Observation (II) |
Design Comments: An identifier for the observation. |
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| code [0..1] Observation (CD) {CWE:D:ObservationType} |
Design Comments: The code value indicates the nature of the observation, and provides context which is necessary for the observation value to be meaningful. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The value or result of the observation. Its content. |
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| Inherits associations from InvestigationComponent | |||||||||
| SourceOf |
Design Comments: The act relationship makes it possible to take note of additional investigations that are related to the core investigation for the ICSR. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipICSRInvestigation} |
Design Comments: The value provided indicates the nature of the relationship between the two investigations. |
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| priorityNumber [0..1] ActRelationship (REAL) |
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| relatedInvestigation [1..1] (RelatedInvestigation) |
Design Comments: The class captures information about investigations into adverse events or product problems that are related to the investigation primarily driving the report (ICSR) These fall essentially into three classes: a) the source or primary investigation by the party first becoming aware of the event, b) investigations related to this event that were initiated by other parties, c) investigations into other events which are related in some way to this investigation.</description> |
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| RelatedInvestigation |
Design Comments: The class captures information about investigations into adverse events or product problems that are related to the investigation primarily driving the report (ICSR) These fall essentially into three classes: a) the source or primary investigation by the party first becoming aware of the event, b) investigations related to this event that were initiated by other parties, c) investigations into other events which are related in some way to this investigation.</description> |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassInvestigation, root= "INVSTG"} |
Design Comments: The value, INVSTG, indicates the act is an investigation. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| code [1..1] (M) Observation (CD) {CWE:D:IndividualCaseSafetyReportType} |
Design Comments: A coded value that indicates the nature of the investigation. |
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| subjectOf1 [0..*] (Subject5) | |||||||||
| subjectOf2 [0..*] (Subject4) | |||||||||
| Subject5 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
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| investigationCharacteristic [1..1] (InvestigationCharacteristic) | |||||||||
| InvestigationCharacteristic | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: The value provided, OBS, indicates that observation information is being passed. |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| code [0..1] Observation (CD) {CWE:D:IndividualCaseSafetyReportCriteria} |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
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| Subject4 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
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| controlActEvent [1..1] (ControlActEvent) |
Design Comments: A report that has been sent as a result of an investigation into or simply the recognition of an adverse event or product problem. In many cases, reports will be distinguished by the role played by the author of the report |
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| ControlActEvent |
Design Comments: A report that has been sent as a result of an investigation into or simply the recognition of an adverse event or product problem. In many cases, reports will be distinguished by the role played by the author of the report |
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| classCode [1..1] (M) ControlAct (CS) {CNE:V:ActClassControlAct, root= "CACT"} |
Design Comments: The value, CACT, indicates the act represents a "system event". Within the ICSR, the event is a report. |
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| moodCode [1..1] (M) ControlAct (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
Design Comments: The value provided, EVN, indicates that the information provided refers to existing information. |
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| id [0..*] ControlAct (DSET<II>) |
Design Comments: An identifier for the report. |
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| code [0..1] ControlAct (CD) {CWE:D:HL7TriggerEventCode} |
Design Comments: Indicates the type of report - is it a new report, a report update, or the withdrawel of a previous report. |
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| confidentialityCode [0..*] ControlAct (DSET<CD>) {CWE:D:Confidentiality} |
Design Comments: A coded indication of of one or more constraints on disclosure of information contained within the report. |
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| reasonCode [0..*] ControlAct (DSET<CD>) {CWE:D:ActReason} |
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| author [0..1] (Author3) |
Design Comments: The participation captures information regarding the author of the report of an adverse event or product problem. |
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| primaryInformationRecipient [0..1] (PrimaryInformationRecipient) |
Design Comments: Indicates an organization or person which is the primary information recipient of a report. |
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| Author3 |
Design Comments: The participation captures information regarding the author of the report of an adverse event or product problem. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: The value, AUT, indicates that the entity participating in the indicated role is the author of the act. |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| PrimaryInformationRecipient |
Design Comments: Indicates an organization or person which is the primary information recipient of a report. |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationPrimaryInformationRecipient, root= "PRCP"} |
Design Comments: The value, PRCP, indicates that the target role is the primary recipient of information. |
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| negationInd [0..1] Participation (BL) |
Design Comments: Makes it possible to specify persons or organizations who did not (negation Indicator = true) receive the report of an adverse event or product problem. |
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| time [0..1] Participation (IVL<TS>) |
Design Comments: An indication of the time at which the report information was received. |
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| modeCode [0..1] Participation (CD) {CWE:D:ParticipationMode} |
Design Comments: A coded indication of the manner in which the information was provided to the recipient. |
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| assignedEntity [1..1] (AssignedEntity) | |||||||||
| Subject9 |
Design Comments: Indicates that the target act is the subject of the source act. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
Design Comments: The value, SBJ, indicates a act has another as a subject. |
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| controlActEvent [1..1] (ControlActEvent) | |||||||||
| Subject10 |
Design Comments: Makes it possible to relate an investigation to observations that provide information about characteristics of the investigation. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
Design Comments: The value, SBJ, indicates a act has another as a subject. |
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| investigationCharacteristic [1..1] (InvestigationCharacteristic) | |||||||||