Interventional studies participation


Parameter Case Report Form and Response Options

Interventional studies participation Yes No Unknown n.a.
Study enrolment due to Covid-19

This profile of a FHIR Observation captures if the patient participated in one or more interventional clinical trials.


Profile - Interventional Clinical Trial Participation

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation

Snapshot

idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionC0..*Extension
modifierExtension?! C0..*Extension
identifierΣ0..*Identifier
basedOnΣ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
partOfΣ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)
statusΣ ?!1..1codeBinding
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1codePattern
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1codePattern
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
subjectS Σ1..1Reference(Patient | Group)
focusΣ0..*Reference(Resource)
encounterΣ0..1Reference(Encounter)
effectiveDateTimedateTime
effectivePeriodPeriod
effectiveTimingTiming
effectiveInstantinstant
issuedΣ0..1instant
performerΣ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
dataAbsentReasonC0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
note0..*Annotation
bodySite0..0CodeableConcept
method0..1CodeableConcept
specimen0..0Reference(Specimen)
device0..1Reference(Device | DeviceMetric)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
lowC0..1SimpleQuantity
highC0..1SimpleQuantity
type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
age0..1Range
text0..1string
hasMemberΣ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)
derivedFromΣ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
codeΣ1..1CodeableConcept
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueStringstring
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
dataAbsentReasonC0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1codePattern
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
valueStringΣ1..1string
dataAbsentReasonC0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemΣ1..1uriPattern
versionΣ0..1string
codeΣ1..1codePattern
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
valueStringΣ0..1string
dataAbsentReasonC0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)


ValueSets

Valuesets are provided with SNOMED-CT codes.

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/ValueSet/yes-no-unknown-other-na

This value set includes codes from the following code systems:


Examples

Yes including EudraCT and NCT numbers

{
"resourceType": "Observation",
"id": "interventional-clinical-trial-participation-yes-2",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
]
},
{
"coding": [
{
"code": "survey",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "03",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "Participation in interventional clinical trials"
}
],
"text": "Has the patient participated in one or more interventional clinical trials?"
},
"coding": [
{
"system": "http://snomed.info/sct",
"code": "373066001",
"display": "Yes (qualifier value)"
}
],
"text": "Patient is enrolled in other studies"
},
{
"type": {
"coding": [
{
"code": "OBI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_03_InterventionalClinicalTrialsParticipation",
"reference": "Organization/Charité"
}
}
],
"status": "final",
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00",
{
"code": {
"coding": [
{
"code": "04",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "EudraCT Number"
}
],
"text": "EudraCT (European Union Drug Regulating Authorities Clinical Trials) registration number"
},
"valueString": "2020-042169-13"
},
{
"code": {
"coding": [
{
"code": "05",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "NCT number"
}
],
"text": "A unique identification code given to each clinical study registered on ClinicalTrials.gov"
},
"valueString": "NCT00001016"
}
]
}


Yes including EudraCT number

{
"resourceType": "Observation",
"id": "interventional-clinical-trial-participation-yes-1",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
]
},
{
"coding": [
{
"code": "survey",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "03",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "Participation in interventional clinical trials"
}
],
"text": "Has the patient participated in one or more interventional clinical trials?"
},
"coding": [
{
"system": "http://snomed.info/sct",
"code": "373066001",
"display": "Yes (qualifier value)"
}
],
"text": "Patient is enrolled in other studies"
},
{
"type": {
"coding": [
{
"code": "OBI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_03_InterventionalClinicalTrialsParticipation",
"reference": "Organization/Charité"
}
}
],
"status": "final",
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00",
{
"code": {
"coding": [
{
"code": "04",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "EudraCT Number"
}
],
"text": "EudraCT (European Union Drug Regulating Authorities Clinical Trials) registration number"
},
"valueString": "2020-042169-13"
}
]
}


Yes including NCT number

{
"resourceType": "Observation",
"id": "interventional-clinical-trial-participation-yes-3",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
]
},
{
"coding": [
{
"code": "survey",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "03",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "Participation in interventional clinical trials"
}
],
"text": "Has the patient participated in one or more interventional clinical trials?"
},
"coding": [
{
"system": "http://snomed.info/sct",
"code": "373066001",
"display": "Yes (qualifier value)"
}
],
"text": "Patient is enrolled in other studies"
},
{
"type": {
"coding": [
{
"code": "OBI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_03_InterventionalClinicalTrialsParticipation",
"reference": "Organization/Charité"
}
}
],
"status": "final",
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00",
{
"code": {
"coding": [
{
"code": "05",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "NCT number"
}
],
"text": "A unique identification code given to each clinical study registered on ClinicalTrials.gov"
},
"valueString": "NCT00001016"
}
]
}


No participation in other studies

{
"resourceType": "Observation",
"id": "interventional-clinical-trial-participation-no",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
]
},
{
"coding": [
{
"code": "survey",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "03",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "Participation in interventional clinical trials"
}
],
"text": "Has the patient participated in one or more interventional clinical trials?"
},
"coding": [
{
"system": "http://snomed.info/sct",
"code": "373067005",
"display": "No (qualifier value)"
}
],
"text": "Patient is not enrolled in other studies"
},
{
"type": {
"coding": [
{
"code": "OBI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_03_InterventionalClinicalTrialsParticipation",
"reference": "Organization/Charité"
}
}
],
"status": "final",
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00"
}


Unknown if participates in other studies

{
"resourceType": "Observation",
"id": "interventional-clinical-trial-participation-unknown",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
]
},
{
"coding": [
{
"code": "survey",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "03",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "Participation in interventional clinical trials"
}
],
"text": "Has the patient participated in one or more interventional clinical trials?"
},
"coding": [
{
"system": "http://snomed.info/sct",
"code": "261665006",
"display": "Unknown (qualifier value)"
}
],
"text": "Unknown if patient is enrolled in other studies"
},
{
"type": {
"coding": [
{
"code": "OBI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_03_InterventionalClinicalTrialsParticipation",
"reference": "Organization/Charité"
}
}
],
"status": "final",
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00"
}


Not applicable

{
"resourceType": "Observation",
"id": "interventional-clinical-trial-participation-not-applicable",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
]
},
{
"coding": [
{
"code": "survey",
"system": "http://terminology.hl7.org/CodeSystem/observation-category"
}
]
}
],
"code": {
"coding": [
{
"code": "03",
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"display": "Participation in interventional clinical trials"
}
],
"text": "Has the patient participated in one or more interventional clinical trials?"
},
"coding": [
{
"system": "http://snomed.info/sct",
"code": "385432009",
"display": "Not applicable (qualifier value)"
}
],
"text": "Not applicable"
},
{
"type": {
"coding": [
{
"code": "OBI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0203"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_03_InterventionalClinicalTrialsParticipation",
"reference": "Organization/Charité"
}
}
],
"status": "final",
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00"
}