Study enrolment due to Covid-19


Parameter Case Report Form and Response Options

Study enrolment due to Covid-19 Yes No Unknown
Confirmed Covid-19 diagnosis as main reason for enrolment in the study ☐ ☐ ☐

This profile of a FHIR Observation captures if a confirmed Covid-19 diagnosis is the main reason for enrolment in the study.


Profile - Study Inclusion due to Covid-19

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19

Snapshot

idΣ0..1id
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionC0..*Extension
modifierExtension?! C0..*Extension
identifierΣ0..*Identifier
basedOnΣ C0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
partOfΣ C0..*Reference(ImagingStudy | Immunization | MedicationAdministration | MedicationDispense | MedicationStatement | Procedure)
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 Σ C1..1Reference(Group | Patient)
focusΣ C0..*Reference(Resource)
encounterΣ C0..1Reference(Encounter)
effectiveDateTimedateTime
effectiveInstantinstant
effectivePeriodPeriod
effectiveTimingTiming
issuedΣ0..1instant
performerΣ C0..*Reference(CareTeam | Organization | Patient | Practitioner | PractitionerRole | 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
specimenC0..0Reference(Specimen)
deviceC0..1Reference(Device | DeviceMetric)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
lowC0..1SimpleQuantity
highC0..1SimpleQuantity
type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
ageC0..1Range
text0..1string
hasMemberΣ C0..*Reference(MolecularSequence | Observation | QuestionnaireResponse)
derivedFromΣ C0..*Reference(DocumentReference | ImagingStudy | Media | MolecularSequence | Observation | QuestionnaireResponse)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
codeΣ1..1CodeableConcept
valueBooleanboolean
valueCodeableConceptCodeableConcept
valueDateTimedateTime
valueIntegerinteger
valuePeriodPeriod
valueQuantityQuantity
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueStringstring
valueTimetime
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

Covid-19 as primary reason for study inclusion

{
"resourceType": "Observation",
"id": "study-inclusion-covid-19-yes",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19"
]
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "OBI"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_02_StudyInclusionCovid19",
"reference": "Organization/Charité"
}
}
],
"status": "final",
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"code": "survey"
}
]
}
],
"code": {
"coding": [
{
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"code": "02",
"display": "Study inclusion due to Covid-19"
}
],
"text": "Confirmed Covid-19 diagnosis as main reason for enrolment in the study"
},
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00",
"coding": [
{
"system": "http://snomed.info/sct",
"code": "373066001",
"display": "Yes (qualifier value)"
}
],
"text": "Covid-19 as primary reason for study inclusion"
}
}


Covid-19 not the primary reason for study inclusion

{
"resourceType": "Observation",
"id": "study-inclusion-covid-19-no",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19"
]
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "OBI"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_02_StudyInclusionCovid19",
"reference": "Organization/Charité"
}
}
],
"status": "final",
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"code": "survey"
}
]
}
],
"code": {
"coding": [
{
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"code": "02",
"display": "Study inclusion due to Covid-19"
}
],
"text": "Confirmed Covid-19 diagnosis as main reason for enrolment in the study"
},
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00",
"coding": [
{
"system": "http://snomed.info/sct",
"code": "373067005",
"display": "No (qualifier value)"
}
],
"text": "Covid-19 not the primary reason for study inclusion"
}
}


Unknown if Covid-19 is primary reason for study inclusion

{
"resourceType": "Observation",
"id": "study-inclusion-covid-19-unknown",
"meta": {
"profile": [
"https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19"
]
},
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "OBI"
}
]
},
"system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
"value": "ecrf_02_StudyInclusionCovid19",
"reference": "Organization/Charité"
}
}
],
"status": "final",
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"code": "survey"
}
]
}
],
"code": {
"coding": [
{
"system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
"code": "02",
"display": "Study inclusion due to Covid-19"
}
],
"text": "Confirmed Covid-19 diagnosis as main reason for enrolment in the study"
},
"subject": {
"reference": "Patient/gecco-patient"
},
"effectiveDateTime": "2020-10-16T08:49:21+02:00",
"coding": [
{
"system": "http://snomed.info/sct",
"code": "261665006",
"display": "Unknown (qualifier value)"
}
],
"text": "Unknown if Covid-19 is primary reason for study inclusion"
}
}