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Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial Use Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductClinicals resource.

MedicinalProductClinicals
Element IdMedicinalProductClinicals
Definition

The clinical particulars - indications, contraindications etc. of a medicinal product, including for regulatory purposes.

Control1..1
Summarytrue
MedicinalProductClinicals.undesirableEffects
Element IdMedicinalProductClinicals.undesirableEffects
Definition

Describe the undesirable effects of the medicinal product.

Control0..*
Summarytrue
MedicinalProductClinicals.undesirableEffects.symptomConditionEffect
Element IdMedicinalProductClinicals.undesirableEffects.symptomConditionEffect
Definition

The symptom, condition or undesirable effect.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.undesirableEffects.classification
Element IdMedicinalProductClinicals.undesirableEffects.classification
Definition

Classification of the effect.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.undesirableEffects.frequencyOfOccurrence
Element IdMedicinalProductClinicals.undesirableEffects.frequencyOfOccurrence
Definition

The frequency of occurrence of the effect.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.undesirableEffects.population
Element IdMedicinalProductClinicals.undesirableEffects.population
Definition

The population group to which this applies.

Control0..*
Summarytrue
MedicinalProductClinicals.undesirableEffects.population.age[x]
Element IdMedicinalProductClinicals.undesirableEffects.population.age[x]
Definition

The age of the specific population.

Control0..1
TypeRange|CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
MedicinalProductClinicals.undesirableEffects.population.gender
Element IdMedicinalProductClinicals.undesirableEffects.population.gender
Definition

The gender of the specific population.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.undesirableEffects.population.race
Element IdMedicinalProductClinicals.undesirableEffects.population.race
Definition

Race of the specific population.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.undesirableEffects.population.physiologicalCondition
Element IdMedicinalProductClinicals.undesirableEffects.population.physiologicalCondition
Definition

The existing physiological conditions of the specific population to which this applies.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.therapeuticIndication
Element IdMedicinalProductClinicals.therapeuticIndication
Definition

Indication for the Medicinal Product.

Control1..*
Summarytrue
MedicinalProductClinicals.therapeuticIndication.diseaseSymptomProcedure
Element IdMedicinalProductClinicals.therapeuticIndication.diseaseSymptomProcedure
Definition

The disease, symptom or procedure that is the indication for treatment.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.therapeuticIndication.diseaseStatus
Element IdMedicinalProductClinicals.therapeuticIndication.diseaseStatus
Definition

The status of the disease or symptom for which the indication applies.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.therapeuticIndication.comorbidity
Element IdMedicinalProductClinicals.therapeuticIndication.comorbidity
Definition

Comorbidity (concurrent condition) or co-infection as part of the indication.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.therapeuticIndication.intendedEffect
Element IdMedicinalProductClinicals.therapeuticIndication.intendedEffect
Definition

The intended effect, aim or strategy to be achieved by the indication.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.therapeuticIndication.duration
Element IdMedicinalProductClinicals.therapeuticIndication.duration
Definition

Timing or duration information as part of the indication.

Control0..1
TypeQuantity
Summarytrue
MedicinalProductClinicals.therapeuticIndication.undesirableEffects
Element IdMedicinalProductClinicals.therapeuticIndication.undesirableEffects
Definition

Information about the use of the medicinal product in relation to other therapies as part of the indication.

Control0..*
TypeSee MedicinalProductClinicals.undesirableEffects
Summarytrue
MedicinalProductClinicals.therapeuticIndication.otherTherapy
Element IdMedicinalProductClinicals.therapeuticIndication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the indication.

Control0..*
Summarytrue
MedicinalProductClinicals.therapeuticIndication.otherTherapy.therapyRelationshipType
Element IdMedicinalProductClinicals.therapeuticIndication.otherTherapy.therapyRelationshipType
Definition

The type of relationship between the medicinal product indication or contraindication and another therapy.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.therapeuticIndication.otherTherapy.medication[x]
Element IdMedicinalProductClinicals.therapeuticIndication.otherTherapy.medication[x]
Definition

Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication.

Control1..1
TypeCodeableConcept|Reference(MedicinalProduct | Medication | Substance | SubstanceSpecification)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
MedicinalProductClinicals.therapeuticIndication.population
Element IdMedicinalProductClinicals.therapeuticIndication.population
Definition

The population group to which this applies.

Control0..*
TypeSee MedicinalProductClinicals.undesirableEffects.population
Summarytrue
MedicinalProductClinicals.contraindication
Element IdMedicinalProductClinicals.contraindication
Definition

Contraindication for the medicinal product.

Control0..*
Summarytrue
MedicinalProductClinicals.contraindication.disease
Element IdMedicinalProductClinicals.contraindication.disease
Definition

The disease, symptom or procedure for the contraindication.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.contraindication.diseaseStatus
Element IdMedicinalProductClinicals.contraindication.diseaseStatus
Definition

The status of the disease or symptom for the contraindication.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.contraindication.comorbidity
Element IdMedicinalProductClinicals.contraindication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.contraindication.therapeuticIndication
Element IdMedicinalProductClinicals.contraindication.therapeuticIndication
Definition

Information about the use of the medicinal product in relation to other therapies as part of the indication.

Control0..*
TypeSee MedicinalProductClinicals.therapeuticIndication
Summarytrue
MedicinalProductClinicals.contraindication.otherTherapy
Element IdMedicinalProductClinicals.contraindication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.

Control0..*
TypeSee MedicinalProductClinicals.therapeuticIndication.otherTherapy
Summarytrue
MedicinalProductClinicals.contraindication.population
Element IdMedicinalProductClinicals.contraindication.population
Definition

The population group to which this applies.

Control0..*
TypeSee MedicinalProductClinicals.undesirableEffects.population
Summarytrue
MedicinalProductClinicals.interactions
Element IdMedicinalProductClinicals.interactions
Definition

The interactions of the medicinal product with other medicinal products, or other forms of interactions.

Control0..*
Summarytrue
MedicinalProductClinicals.interactions.interaction
Element IdMedicinalProductClinicals.interactions.interaction
Definition

The interaction described.

Control0..1
Typestring
Summarytrue
MedicinalProductClinicals.interactions.interactant
Element IdMedicinalProductClinicals.interactions.interactant
Definition

The specific medication, food or laboratory test that interacts.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.interactions.type
Element IdMedicinalProductClinicals.interactions.type
Definition

The type of the interaction.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.interactions.effect
Element IdMedicinalProductClinicals.interactions.effect
Definition

The effect of the interaction.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.interactions.incidence
Element IdMedicinalProductClinicals.interactions.incidence
Definition

The incidence of the interaction.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductClinicals.interactions.management
Element IdMedicinalProductClinicals.interactions.management
Definition

Actions for managing the interaction.

Control0..1
TypeCodeableConcept
Summarytrue