Interventional studies participation


PARAMETER CASE REPORT FORM RESPONSE OPTIONS
Has the patient participated in one or more interventional clinical trials?
If yes, please provide EudraCT or NCT number (if available)
Yes / No / Unknown / n.a.

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
id0..1string
extensionI0..*Extension
versionIdΣ0..1id
lastUpdatedΣ0..1instant
sourceΣ0..1uri
profileS Σ0..*canonical(StructureDefinition)
securityΣ0..*CodingBinding
tagΣ0..*Coding
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
identifierΣ0..*Identifier
basedOnΣ I0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
partOfΣ I0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)
statusΣ ?!1..1codeBinding
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
subjectS Σ I1..1Reference(Patient | Group)
focusΣ I0..*Reference(Resource)
encounterΣ I0..1Reference(Encounter)
effectiveDateTimedateTime
effectivePeriodPeriod
effectiveTimingTiming
effectiveInstantinstant
issuedΣ0..1instant
performerΣ I0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
note0..*Annotation
bodySite0..0CodeableConcept
method0..1CodeableConcept
specimenI0..0Reference(Specimen)
deviceI0..1Reference(Device | DeviceMetric)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
lowI0..1SimpleQuantity
highI0..1SimpleQuantity
type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
ageI0..1Range
text0..1string
hasMemberΣ I0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)
derivedFromΣ I0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
codeΣ1..1CodeableConcept
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueStringstring
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
valueStringΣ1..1string
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
valueStringΣ0..1string
dataAbsentReasonI0..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

ValueSet 'YesNoUnknownOtherNa'

Version1.0
Published byCharité
StatusActive
ExperimentalFalse

Yes/No/Unknown/Other/Na response options

This value set includes codes from the following code systems:


Examples

Yes including EudraCT and NCT numbers

{
    "resourceType": "Observation",
    "id": "571c047d-3689-4fb7-9292-c1d71faecf72",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_03_InterventionalClinicalTrialsParticipation",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "category":  [
        {
            "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": "03",
                "display": "Participation in interventional clinical trials"
            }
        ],
        "text": "Has the patient participated in one or more interventional clinical trials?"
    },
    "subject": {
        "reference": "Patient/c786ac3c-0579-4aa2-adda-db784b214ad6"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00",
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "373066001",
                "display": "Yes (qualifier value)"
            }
        ],
        "text": "Patient is enrolled in other studies"
    },
    "component":  [
        {
            "code": {
                "coding":  [
                    {
                        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                        "code": "04",
                        "display": "EudraCT Number"
                    }
                ],
                "text": "EudraCT (European Union Drug Regulating Authorities Clinical Trials) registration number"
            },
            "valueString": "2020-042169-13"
        },
        {
            "code": {
                "coding":  [
                    {
                        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                        "code": "05",
                        "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": "ee7afc8a-77fd-4394-a475-6171865f7119",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_03_InterventionalClinicalTrialsParticipation",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "category":  [
        {
            "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": "03",
                "display": "Participation in interventional clinical trials"
            }
        ],
        "text": "Has the patient participated in one or more interventional clinical trials?"
    },
    "subject": {
        "reference": "Patient/c786ac3c-0579-4aa2-adda-db784b214ad6"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00",
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "373066001",
                "display": "Yes (qualifier value)"
            }
        ],
        "text": "Patient is enrolled in other studies"
    },
    "component":  [
        {
            "code": {
                "coding":  [
                    {
                        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                        "code": "04",
                        "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": "ff5b2de8-cd99-49e3-b667-42c22248a1f4",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_03_InterventionalClinicalTrialsParticipation",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "category":  [
        {
            "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": "03",
                "display": "Participation in interventional clinical trials"
            }
        ],
        "text": "Has the patient participated in one or more interventional clinical trials?"
    },
    "subject": {
        "reference": "Patient/c786ac3c-0579-4aa2-adda-db784b214ad6"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00",
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "373066001",
                "display": "Yes (qualifier value)"
            }
        ],
        "text": "Patient is enrolled in other studies"
    },
    "component":  [
        {
            "code": {
                "coding":  [
                    {
                        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                        "code": "05",
                        "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": "9cd9ca09-3b1f-41eb-bd07-c8c78c236ab6",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_03_InterventionalClinicalTrialsParticipation",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "category":  [
        {
            "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": "03",
                "display": "Participation in interventional clinical trials"
            }
        ],
        "text": "Has the patient participated in one or more interventional clinical trials?"
    },
    "subject": {
        "reference": "Patient/c786ac3c-0579-4aa2-adda-db784b214ad6"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00",
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "373067005",
                "display": "No (qualifier value)"
            }
        ],
        "text": "Patient is not enrolled in other studies"
    }
}


Unknown if participates in other studies

{
    "resourceType": "Observation",
    "id": "d15919ca-5407-4a10-857b-88d123d8e609",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_03_InterventionalClinicalTrialsParticipation",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "category":  [
        {
            "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": "03",
                "display": "Participation in interventional clinical trials"
            }
        ],
        "text": "Has the patient participated in one or more interventional clinical trials?"
    },
    "subject": {
        "reference": "Patient/c786ac3c-0579-4aa2-adda-db784b214ad6"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00",
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "261665006",
                "display": "Unknown (qualifier value)"
            }
        ],
        "text": "Unknown if patient is enrolled in other studies"
    }
}


Not applicable

{
    "resourceType": "Observation",
    "id": "7c183344-72a2-48f3-97aa-18f871ca32f5",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
                        "code": "OBI"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_03_InterventionalClinicalTrialsParticipation",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "category":  [
        {
            "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": "03",
                "display": "Participation in interventional clinical trials"
            }
        ],
        "text": "Has the patient participated in one or more interventional clinical trials?"
    },
    "subject": {
        "reference": "Patient/c786ac3c-0579-4aa2-adda-db784b214ad6"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00",
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "385432009",
                "display": "Not applicable (qualifier value)"
            }
        ],
        "text": "Not applicable"
    }
}