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Biomedical Research and Regulation Work Group | Maturity Level: 1 | Trial Use | Security Category: Anonymous | Compartments: Not linked to any defined compartments |
Detailed Descriptions for the elements in the ClinicalUseDefinition resource.
ClinicalUseDefinition | |||||||||
Element Id | ClinicalUseDefinition | ||||||||
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. | ||||||||
Cardinality | 0..* | ||||||||
Type | DomainResource | ||||||||
Summary | false | ||||||||
Invariants |
| ||||||||
ClinicalUseDefinition.identifier | |||||||||
Element Id | ClinicalUseDefinition.identifier | ||||||||
Definition | Business identifier for this issue. | ||||||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||||||
Cardinality | 0..* | ||||||||
Type | Identifier | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.type | |||||||||
Element Id | ClinicalUseDefinition.type | ||||||||
Definition | indication | contraindication | interaction | undesirable-effect | warning. | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | ClinicalUseDefinitionType (Required) | ||||||||
Type | code | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.category | |||||||||
Element Id | ClinicalUseDefinition.category | ||||||||
Definition | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines". | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | ClinicalUseDefinitionCategory (Preferred) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.subject | |||||||||
Element Id | ClinicalUseDefinition.subject | ||||||||
Definition | The medication or procedure for which this is an indication. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.status | |||||||||
Element Id | ClinicalUseDefinition.status | ||||||||
Definition | Whether this is a current issue or one that has been retired etc. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | PublicationStatus (Preferred) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication | |||||||||
Element Id | ClinicalUseDefinition.contraindication | ||||||||
Definition | Specifics for when this is a contraindication. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | |||||||||
Element Id | ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | ||||||||
Definition | The situation that is being documented as contraindicating against this item. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | DiseaseSymptomProcedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.diseaseStatus | |||||||||
Element Id | ClinicalUseDefinition.contraindication.diseaseStatus | ||||||||
Definition | The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic". | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | DiseaseStatus (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.comorbidity | |||||||||
Element Id | ClinicalUseDefinition.contraindication.comorbidity | ||||||||
Definition | A comorbidity (concurrent condition) or coinfection. | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | DiseaseSymptomProcedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.indication | |||||||||
Element Id | ClinicalUseDefinition.contraindication.indication | ||||||||
Definition | The indication which this is a contraidication for. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(ClinicalUseDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.otherTherapy | |||||||||
Element Id | ClinicalUseDefinition.contraindication.otherTherapy | ||||||||
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the contraindication. | ||||||||
Cardinality | 0..* | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | |||||||||
Element Id | ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | ||||||||
Definition | The type of relationship between the medicinal product indication or contraindication and another therapy. | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | TherapyRelationshipType (Preferred) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.contraindication.otherTherapy.therapy | |||||||||
Element Id | ClinicalUseDefinition.contraindication.otherTherapy.therapy | ||||||||
Definition | Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication. | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | Therapy (Example) | ||||||||
Type | CodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication | |||||||||
Element Id | ClinicalUseDefinition.indication | ||||||||
Definition | Specifics for when this is an indication. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.diseaseSymptomProcedure | |||||||||
Element Id | ClinicalUseDefinition.indication.diseaseSymptomProcedure | ||||||||
Definition | The situation that is being documented as an indicaton for this item. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | DiseaseSymptomProcedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.diseaseStatus | |||||||||
Element Id | ClinicalUseDefinition.indication.diseaseStatus | ||||||||
Definition | The status of the disease or symptom for the indication, for example "chronic" or "metastatic". | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | DiseaseStatus (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.comorbidity | |||||||||
Element Id | ClinicalUseDefinition.indication.comorbidity | ||||||||
Definition | A comorbidity (concurrent condition) or coinfection as part of the indication. | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | DiseaseSymptomProcedure (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.intendedEffect | |||||||||
Element Id | ClinicalUseDefinition.indication.intendedEffect | ||||||||
Definition | The intended effect, aim or strategy to be achieved. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | ProductIntendedUse (Preferred) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.duration[x] | |||||||||
Element Id | ClinicalUseDefinition.indication.duration[x] | ||||||||
Definition | Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months). | ||||||||
Cardinality | 0..1 | ||||||||
Type | Range|string | ||||||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.undesirableEffect | |||||||||
Element Id | ClinicalUseDefinition.indication.undesirableEffect | ||||||||
Definition | An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(ClinicalUseDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.indication.otherTherapy | |||||||||
Element Id | ClinicalUseDefinition.indication.otherTherapy | ||||||||
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the indication. | ||||||||
Cardinality | 0..* | ||||||||
Type | See ClinicalUseDefinition.contraindication.otherTherapy | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction | |||||||||
Element Id | ClinicalUseDefinition.interaction | ||||||||
Definition | Specifics for when this is an interaction. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.interactant | |||||||||
Element Id | ClinicalUseDefinition.interaction.interactant | ||||||||
Definition | The specific medication, food, substance or laboratory test that interacts. | ||||||||
Cardinality | 0..* | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.interactant.item[x] | |||||||||
Element Id | ClinicalUseDefinition.interaction.interactant.item[x] | ||||||||
Definition | The specific medication, food or laboratory test that interacts. | ||||||||
Cardinality | 1..1 | ||||||||
Terminology Binding | Interactant (Example) | ||||||||
Type | Reference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)|CodeableConcept | ||||||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.type | |||||||||
Element Id | ClinicalUseDefinition.interaction.type | ||||||||
Definition | The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | InteractionType (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.effect | |||||||||
Element Id | ClinicalUseDefinition.interaction.effect | ||||||||
Definition | The effect of the interaction, for example "reduced gastric absorption of primary medication". | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | InteractionEffect (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.incidence | |||||||||
Element Id | ClinicalUseDefinition.interaction.incidence | ||||||||
Definition | The incidence of the interaction, e.g. theoretical, observed. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | InteractionIncidence (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.interaction.management | |||||||||
Element Id | ClinicalUseDefinition.interaction.management | ||||||||
Definition | Actions for managing the interaction. | ||||||||
Cardinality | 0..* | ||||||||
Terminology Binding | InteractionManagement (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.population | |||||||||
Element Id | ClinicalUseDefinition.population | ||||||||
Definition | The population group to which this applies. | ||||||||
Cardinality | 0..* | ||||||||
Type | Reference(Group) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect | ||||||||
Definition | Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | ||||||||
Definition | The situation in which the undesirable effect may manifest. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | UndesirableEffectSymptom (Example) | ||||||||
Type | CodeableReference(ObservationDefinition) | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect.classification | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect.classification | ||||||||
Definition | High level classification of the effect. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | UndesirableEffectClassification (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | |||||||||
Element Id | ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | ||||||||
Definition | How often the effect is seen. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | UndesirablEffectFrequency (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.warning | |||||||||
Element Id | ClinicalUseDefinition.warning | ||||||||
Definition | A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'. | ||||||||
Cardinality | 0..1 | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.warning.description | |||||||||
Element Id | ClinicalUseDefinition.warning.description | ||||||||
Definition | A textual definition of this warning, with formatting. | ||||||||
Cardinality | 0..1 | ||||||||
Type | markdown | ||||||||
Summary | true | ||||||||
ClinicalUseDefinition.warning.code | |||||||||
Element Id | ClinicalUseDefinition.warning.code | ||||||||
Definition | A coded or unformatted textual definition of this warning. | ||||||||
Cardinality | 0..1 | ||||||||
Terminology Binding | WarningType (Example) | ||||||||
Type | CodeableConcept | ||||||||
Summary | true |