# Generated from FHIR 4.0.1-9346c8cc45 (http://hl7.org/fhir/StructureDefinition/ResearchStudy). # 2024, SMART Health IT. from . import domainresource class ResearchStudy(domainresource.DomainResource): """ Investigation to increase healthcare-related patient-independent knowledge. A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects. """ resource_type = "ResearchStudy" def __init__(self, jsondict=None, strict=True): """ Initialize all valid properties. :raises: FHIRValidationError on validation errors, unless strict is False :param dict jsondict: A JSON dictionary to use for initialization :param bool strict: If True (the default), invalid variables will raise a TypeError """ self.arm = None """ Defined path through the study for a subject. List of `ResearchStudyArm` items (represented as `dict` in JSON). """ self.category = None """ Classifications for the study. List of `CodeableConcept` items (represented as `dict` in JSON). """ self.condition = None """ Condition being studied. List of `CodeableConcept` items (represented as `dict` in JSON). """ self.contact = None """ Contact details for the study. List of `ContactDetail` items (represented as `dict` in JSON). """ self.description = None """ What this is study doing. Type `str`. """ self.enrollment = None """ Inclusion & exclusion criteria. List of `FHIRReference` items (represented as `dict` in JSON). """ self.focus = None """ Drugs, devices, etc. under study. List of `CodeableConcept` items (represented as `dict` in JSON). """ self.identifier = None """ Business Identifier for study. List of `Identifier` items (represented as `dict` in JSON). """ self.keyword = None """ Used to search for the study. List of `CodeableConcept` items (represented as `dict` in JSON). """ self.location = None """ Geographic region(s) for study. List of `CodeableConcept` items (represented as `dict` in JSON). """ self.note = None """ Comments made about the study. List of `Annotation` items (represented as `dict` in JSON). """ self.objective = None """ A goal for the study. List of `ResearchStudyObjective` items (represented as `dict` in JSON). """ self.partOf = None """ Part of larger study. List of `FHIRReference` items (represented as `dict` in JSON). """ self.period = None """ When the study began and ended. Type `Period` (represented as `dict` in JSON). """ self.phase = None """ n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4. Type `CodeableConcept` (represented as `dict` in JSON). """ self.primaryPurposeType = None """ treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility. Type `CodeableConcept` (represented as `dict` in JSON). """ self.principalInvestigator = None """ Researcher who oversees multiple aspects of the study. Type `FHIRReference` (represented as `dict` in JSON). """ self.protocol = None """ Steps followed in executing study. List of `FHIRReference` items (represented as `dict` in JSON). """ self.reasonStopped = None """ accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of- study-progress | temporarily-closed-per-study-design. Type `CodeableConcept` (represented as `dict` in JSON). """ self.relatedArtifact = None """ References and dependencies. List of `RelatedArtifact` items (represented as `dict` in JSON). """ self.site = None """ Facility where study activities are conducted. List of `FHIRReference` items (represented as `dict` in JSON). """ self.sponsor = None """ Organization that initiates and is legally responsible for the study. Type `FHIRReference` (represented as `dict` in JSON). """ self.status = None """ active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to- accrual-and-intervention | withdrawn. Type `str`. """ self.title = None """ Name for this study. Type `str`. """ super(ResearchStudy, self).__init__(jsondict=jsondict, strict=strict) def elementProperties(self): js = super(ResearchStudy, self).elementProperties() js.extend([ ("arm", "arm", ResearchStudyArm, True, None, False), ("category", "category", codeableconcept.CodeableConcept, True, None, False), ("condition", "condition", codeableconcept.CodeableConcept, True, None, False), ("contact", "contact", contactdetail.ContactDetail, True, None, False), ("description", "description", str, False, None, False), ("enrollment", "enrollment", fhirreference.FHIRReference, True, None, False), ("focus", "focus", codeableconcept.CodeableConcept, True, None, False), ("identifier", "identifier", identifier.Identifier, True, None, False), ("keyword", "keyword", codeableconcept.CodeableConcept, True, None, False), ("location", "location", codeableconcept.CodeableConcept, True, None, False), ("note", "note", annotation.Annotation, True, None, False), ("objective", "objective", ResearchStudyObjective, True, None, False), ("partOf", "partOf", fhirreference.FHIRReference, True, None, False), ("period", "period", period.Period, False, None, False), ("phase", "phase", codeableconcept.CodeableConcept, False, None, False), ("primaryPurposeType", "primaryPurposeType", codeableconcept.CodeableConcept, False, None, False), ("principalInvestigator", "principalInvestigator", fhirreference.FHIRReference, False, None, False), ("protocol", "protocol", fhirreference.FHIRReference, True, None, False), ("reasonStopped", "reasonStopped", codeableconcept.CodeableConcept, False, None, False), ("relatedArtifact", "relatedArtifact", relatedartifact.RelatedArtifact, True, None, False), ("site", "site", fhirreference.FHIRReference, True, None, False), ("sponsor", "sponsor", fhirreference.FHIRReference, False, None, False), ("status", "status", str, False, None, True), ("title", "title", str, False, None, False), ]) return js from . import backboneelement class ResearchStudyArm(backboneelement.BackboneElement): """ Defined path through the study for a subject. Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. """ resource_type = "ResearchStudyArm" def __init__(self, jsondict=None, strict=True): """ Initialize all valid properties. :raises: FHIRValidationError on validation errors, unless strict is False :param dict jsondict: A JSON dictionary to use for initialization :param bool strict: If True (the default), invalid variables will raise a TypeError """ self.description = None """ Short explanation of study path. Type `str`. """ self.name = None """ Label for study arm. Type `str`. """ self.type = None """ Categorization of study arm. Type `CodeableConcept` (represented as `dict` in JSON). """ super(ResearchStudyArm, self).__init__(jsondict=jsondict, strict=strict) def elementProperties(self): js = super(ResearchStudyArm, self).elementProperties() js.extend([ ("description", "description", str, False, None, False), ("name", "name", str, False, None, True), ("type", "type", codeableconcept.CodeableConcept, False, None, False), ]) return js class ResearchStudyObjective(backboneelement.BackboneElement): """ A goal for the study. A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. """ resource_type = "ResearchStudyObjective" def __init__(self, jsondict=None, strict=True): """ Initialize all valid properties. :raises: FHIRValidationError on validation errors, unless strict is False :param dict jsondict: A JSON dictionary to use for initialization :param bool strict: If True (the default), invalid variables will raise a TypeError """ self.name = None """ Label for the objective. Type `str`. """ self.type = None """ primary | secondary | exploratory. Type `CodeableConcept` (represented as `dict` in JSON). """ super(ResearchStudyObjective, self).__init__(jsondict=jsondict, strict=strict) def elementProperties(self): js = super(ResearchStudyObjective, self).elementProperties() js.extend([ ("name", "name", str, False, None, False), ("type", "type", codeableconcept.CodeableConcept, False, None, False), ]) return js from . import annotation from . import codeableconcept from . import contactdetail from . import fhirreference from . import identifier from . import period from . import relatedartifact