{ "resourceType": "StructureDefinition", "id": "ResearchStudy", "meta": { "lastUpdated": "2021-01-01T21:58:31.578+00:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Specialized.Public Health & Research" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 0 }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "business" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status", "valueCode": ".status = entered-in-error" } ], "url": "http://hl7.org/fhir/StructureDefinition/ResearchStudy", "version": "4.6.0", "name": "ResearchStudy", "status": "draft", "date": "2021-01-01T21:58:31+00:00", "publisher": "Health Level Seven International (Biomedical Research and Regulation)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" } ] }, { "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim/index.cfm" } ] } ], "description": "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.", "fhirVersion": "4.6.0", "mapping": [ { "identity": "BRIDG5.1", "uri": "https://bridgmodel.nci.nih.gov", "name": "BRIDG 5.1 Mapping" }, { "identity": "v2", "uri": "http://hl7.org/v2", "name": "HL7 v2 Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" }, { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "clinicaltrials-gov", "uri": "http://clinicaltrials.gov", "name": "ClinicalTrials.gov Mapping" } ], "kind": "resource", "abstract": false, "type": "ResearchStudy", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "ResearchStudy", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "440,0" } ], "path": "ResearchStudy", "short": "Investigation to increase healthcare-related patient-independent knowledge", "definition": "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 or stability data about drug products or drug substances.", "comment": "Need to make sure we encompass public health studies.", "alias": [ "Clinical Trial", "Study" ], "min": 0, "max": "*", "mapping": [ { "identity": "BRIDG5.1", "map": "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion" }, { "identity": "v2", "map": "OBX" }, { "identity": "rim", "map": "Observation[classCode=CLNTRL, moodCode=EVN]" }, { "identity": "w5", "map": "clinical.diagnostics" } ] }, { "id": "ResearchStudy.url", "path": "ResearchStudy.url", "short": "Canonical identifier for this study resource", "definition": "Canonical identifier for this study resource, represented as a globally unique URI.", "min": 0, "max": "1", "type": [ { "code": "uri" } ] }, { "id": "ResearchStudy.identifier", "path": "ResearchStudy.identifier", "short": "Business Identifier for study", "definition": "Identifiers assigned to this research study by the sponsor or other systems.", "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.", "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Organization's Unique Protocol ID; Secondary IDs" }, { "identity": "w5", "map": "FiveWs.identifier" }, { "identity": "BRIDG5.1", "map": "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)" }, { "identity": "rim", "map": ".identifier" } ] }, { "id": "ResearchStudy.version", "path": "ResearchStudy.version", "short": "Business identifier for the study record", "definition": "Business identifier for the study record.", "min": 0, "max": "1", "type": [ { "code": "string" } ] }, { "id": "ResearchStudy.name", "path": "ResearchStudy.name", "short": "Name for this study (computer friendly)", "definition": "Name for this study (computer friendly).", "min": 0, "max": "1", "type": [ { "code": "string" } ] }, { "id": "ResearchStudy.title", "path": "ResearchStudy.title", "short": "Name for this study (for computers)", "definition": "A short, descriptive label for the study particularly for computer use.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Brief Title" }, { "identity": "BRIDG5.1", "map": "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)" } ] }, { "id": "ResearchStudy.label", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "40,0" } ], "path": "ResearchStudy.label", "short": "Additional names for the study", "definition": "Additional names for the study.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.label.type", "path": "ResearchStudy.label.type", "short": "short | public | scientific", "definition": "Kind of name.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyTitleType" } ], "strength": "extensible", "description": "desc.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-label-type" } }, { "id": "ResearchStudy.label.value", "path": "ResearchStudy.label.value", "short": "The name", "definition": "The name.", "min": 0, "max": "1", "type": [ { "code": "string" } ] }, { "id": "ResearchStudy.protocol", "path": "ResearchStudy.protocol", "short": "Steps followed in executing study", "definition": "The set of steps expected to be performed as part of the execution of the study.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/PlanDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Interventions; Arm/Intervention Cross-Reference" }, { "identity": "BRIDG5.1", "map": "StudyProtocolDocumentVersionPublicTitle.name" }, { "identity": "rim", "map": ".outboundRelationship[typeCode=DEFN].target" } ] }, { "id": "ResearchStudy.partOf", "path": "ResearchStudy.partOf", "short": "Part of larger study", "definition": "A larger research study of which this particular study is a component or step.", "requirements": "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.", "alias": [ "container" ], "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "isSummary": true, "mapping": [ { "identity": "BRIDG5.1", "map": "CompanionStudyRelationship" }, { "identity": "rim", "map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" } ] }, { "id": "ResearchStudy.relatedArtifact", "path": "ResearchStudy.relatedArtifact", "short": "References and dependencies", "definition": "Citations, references and other related documents.", "min": 0, "max": "*", "type": [ { "code": "RelatedArtifact" } ], "mapping": [ { "identity": "clinicaltrials-gov", "map": "Citations, Links, Available Study Data/Documents" }, { "identity": "BRIDG5.1", "map": "StudyProtocolDocument, StudyProtocolDocumentVersion" } ] }, { "id": "ResearchStudy.date", "path": "ResearchStudy.date", "short": "Date the resource last changed", "definition": "Date the resource last changed.", "min": 0, "max": "1", "type": [ { "code": "dateTime" } ] }, { "id": "ResearchStudy.status", "path": "ResearchStudy.status", "short": "draft | active | retired | unknown", "definition": "The publication state of the resource (not of the study).", "min": 1, "max": "1", "type": [ { "code": "code" } ], "isModifier": true, "isModifierReason": "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PublicationStatus" } ], "strength": "required", "description": "Codes that convey the current publication status of the research study resource.", "valueSet": "http://hl7.org/fhir/ValueSet/publication-status" }, "mapping": [ { "identity": "w5", "map": "FiveWs.status" }, { "identity": "BRIDG5.1", "map": "StudyOverallStatus.code" }, { "identity": "rim", "map": ".status" } ] }, { "id": "ResearchStudy.primaryPurposeType", "path": "ResearchStudy.primaryPurposeType", "short": "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility", "definition": "The type of study based upon the intent of the study activities. A classification of the intent of the study.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyPrimaryPurposeType" } ], "strength": "extensible", "description": "Codes for the main intent of the study.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type" }, "mapping": [ { "identity": "BRIDG5.1", "map": "StudyProtocolVersion.primaryPurposeTypeCode" } ] }, { "id": "ResearchStudy.phase", "path": "ResearchStudy.phase", "short": "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4", "definition": "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyPhase" } ], "strength": "example", "description": "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-phase" }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Study Phase" }, { "identity": "BRIDG5.1", "map": "StudyProtocolVersion.phaseCode" } ] }, { "id": "ResearchStudy.category", "path": "ResearchStudy.category", "short": "Classifications for the study", "definition": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyCategory" } ], "strength": "example", "description": "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc." }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" }, { "identity": "BRIDG5.1", "map": "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode" } ] }, { "id": "ResearchStudy.focus", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "840,0" } ], "path": "ResearchStudy.focus", "short": "Drugs, devices, etc. under study", "definition": "The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.focus.productCode", "path": "ResearchStudy.focus.productCode", "short": "Identification of product under study", "definition": "Identification of product under study. This may be any combination of code and/or name.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyFocus" } ], "strength": "example", "description": "Codes for medications, devices and other interventions." }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Focus of Study" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "BRIDG5.1", "map": "InterventionalStudyProtocol.interventionTypeCode" } ] }, { "id": "ResearchStudy.focus.focusType", "path": "ResearchStudy.focus.focusType", "short": "medication | device | intervention | factor", "definition": "Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristic.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyFocusType" } ], "strength": "extensible", "description": "defn.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-focus-type" } }, { "id": "ResearchStudy.focus.factor", "path": "ResearchStudy.focus.factor", "short": "An independent variable manipulated by the experimentalist", "definition": "A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assay.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ] }, { "id": "ResearchStudy.condition", "path": "ResearchStudy.condition", "short": "Condition being studied", "definition": "The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ConditionCode" } ], "strength": "example", "description": "Identification of the condition or diagnosis.", "valueSet": "http://hl7.org/fhir/ValueSet/condition-code" }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Conditions" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "BRIDG5.1", "map": "StudyCondition.code" } ] }, { "id": "ResearchStudy.keyword", "path": "ResearchStudy.keyword", "short": "Used to search for the study", "definition": "Key terms to aid in searching for or filtering the study.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyKeyword" } ], "strength": "example", "description": "Words associated with the study that may be useful in discovery." }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Keywords" }, { "identity": "BRIDG5.1", "map": "DocumentVersion.keywordCode; DocumentVersion.keywordText" } ] }, { "id": "ResearchStudy.location", "path": "ResearchStudy.location", "short": "Geographic region(s) for study", "definition": "Indicates a country, state or other region where the study is taking place.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Jurisdiction" }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding", "valueBoolean": true } ], "strength": "extensible", "description": "Countries and regions within which this artifact is targeted for use.", "valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction" }, "mapping": [ { "identity": "BRIDG5.1", "map": "StudyProtocolVersion.participatingLocationCode" } ] }, { "id": "ResearchStudy.descriptionSummary", "path": "ResearchStudy.descriptionSummary", "short": "A brief summary of the study description", "definition": "A brief summary of the study description.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ] }, { "id": "ResearchStudy.description", "path": "ResearchStudy.description", "short": "What this is study doing", "definition": "A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.description.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ], "mapping": [ { "identity": "clinicaltrials-gov", "map": "Detailed Description" }, { "identity": "BRIDG5.1", "map": "StudyProtocolDocumentVersion.publicDescription" } ] }, { "id": "ResearchStudy.period", "path": "ResearchStudy.period", "short": "When the study began and ended", "definition": "Identifies the start date and the expected (or actual, depending on status) end date for the study.", "alias": [ "timing" ], "min": 0, "max": "1", "type": [ { "code": "Period" } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Study Start Date (start); Study Completion Date (end)" }, { "identity": "w5", "map": "FiveWs.done[x]" }, { "identity": "BRIDG5.1", "map": "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration" }, { "identity": "rim", "map": ".effectiveTime" } ] }, { "id": "ResearchStudy.contact", "path": "ResearchStudy.contact", "short": "Contact details for the study", "definition": "Contact details to assist a user in learning more about or engaging with the study.", "min": 0, "max": "*", "type": [ { "code": "ContactDetail" } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators" }, { "identity": "BRIDG5.1", "map": "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion" } ] }, { "id": "ResearchStudy.sponsor", "path": "ResearchStudy.sponsor", "short": "Organization that initiates and is legally responsible for the study", "definition": "An organization that initiates the investigation and is legally responsible for the study.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Sponsor" }, { "identity": "w5", "map": "FiveWs.actor" }, { "identity": "BRIDG5.1", "map": "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode" }, { "identity": "rim", "map": ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]" } ] }, { "id": "ResearchStudy.principalInvestigator", "path": "ResearchStudy.principalInvestigator", "short": "Researcher who oversees multiple aspects of the study", "definition": "A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ] } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Principal Investigator" }, { "identity": "w5", "map": "FiveWs.actor" }, { "identity": "BRIDG5.1", "map": "StudyInvestigator" } ] }, { "id": "ResearchStudy.site", "path": "ResearchStudy.site", "short": "Facility where study activities are conducted", "definition": "A facility in which study activities are conducted.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Location", "http://hl7.org/fhir/StructureDefinition/ResearchStudy", "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Facility" }, { "identity": "w5", "map": "FiveWs.where[x]" }, { "identity": "BRIDG5.1", "map": "PlannedStudySite; StudySite" } ] }, { "id": "ResearchStudy.note", "path": "ResearchStudy.note", "short": "Comments made about the study", "definition": "Comments made about the study by the performer, subject or other participants.", "min": 0, "max": "*", "type": [ { "code": "Annotation" } ], "mapping": [ { "identity": "BRIDG5.1", "map": "No BRIDG mapping" }, { "identity": "rim", "map": ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]" } ] }, { "id": "ResearchStudy.classification", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "40,190" } ], "path": "ResearchStudy.classification", "short": "Classification for the study", "definition": "Classification for the study.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.classification.type", "path": "ResearchStudy.classification.type", "short": "phase | category | keyword", "definition": "Type of classifier.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyCLassificationType" } ], "strength": "extensible", "description": "desc.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-classification-type" } }, { "id": "ResearchStudy.classification.classifier", "path": "ResearchStudy.classification.classifier", "short": "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4", "definition": "Value of classifier.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyClassificationClassifier" } ], "strength": "extensible", "description": "desc.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-classification-classifier" } }, { "id": "ResearchStudy.associatedParty", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "40,280" } ], "path": "ResearchStudy.associatedParty", "short": "Sponsors, collaborators, and other parties", "definition": "Sponsors, collaborators, and other parties.", "comment": "For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.", "requirements": "While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.associatedParty.name", "path": "ResearchStudy.associatedParty.name", "short": "Name of associated party", "definition": "Name of associated party.", "min": 0, "max": "1", "type": [ { "code": "string" } ] }, { "id": "ResearchStudy.associatedParty.role", "path": "ResearchStudy.associatedParty.role", "short": "sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair", "definition": "Type of association.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyPartyRole" } ], "strength": "extensible", "description": "desc.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-party-role" } }, { "id": "ResearchStudy.associatedParty.classifier", "path": "ResearchStudy.associatedParty.classifier", "short": "nih | fda", "definition": "Organisational type of association.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyPartyOrganizationType" } ], "strength": "extensible", "description": "desc.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-party-org-type" } }, { "id": "ResearchStudy.associatedParty.party", "path": "ResearchStudy.associatedParty.party", "short": "Individual or organization associated with study (use practitionerRole to specify their organisation)", "definition": "Individual or organization associated with study (use practitionerRole to specify their organisation).", "comment": "Suggestions of a better attribute name are appreciated", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://hl7.org/fhir/StructureDefinition/Organization" ] } ] }, { "id": "ResearchStudy.currentState", "path": "ResearchStudy.currentState", "short": "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", "definition": "Current status of the study.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyStudyStatus" } ], "strength": "preferred", "description": "defn.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-status" } }, { "id": "ResearchStudy.statusDate", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "40,410" } ], "path": "ResearchStudy.statusDate", "short": "Status of study with time for that status", "definition": "Status of study with time for that status.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.statusDate.activity", "path": "ResearchStudy.statusDate.activity", "short": "Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting", "definition": "Label for status or state.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyStatusActivity" } ], "strength": "extensible", "description": "defn.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-statusDate-activity" } }, { "id": "ResearchStudy.statusDate.actual", "path": "ResearchStudy.statusDate.actual", "short": "Actual if true else anticipated", "definition": "Actual if true else anticipated.", "min": 0, "max": "1", "type": [ { "code": "boolean" } ] }, { "id": "ResearchStudy.statusDate.period", "path": "ResearchStudy.statusDate.period", "short": "Date range", "definition": "Date range.", "min": 1, "max": "1", "type": [ { "code": "Period" } ] }, { "id": "ResearchStudy.whyStopped", "path": "ResearchStudy.whyStopped", "short": "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design", "definition": "A description and/or code explaining the premature termination of the study.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyReasonStopped" } ], "strength": "example", "description": "Codes for why the study ended prematurely.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-reason-stopped" }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Why Study Stopped" }, { "identity": "w5", "map": "FiveWs.why[x]" }, { "identity": "BRIDG5.1", "map": "StudyOverallStatus.studyStoppedReasonCode" } ] }, { "id": "ResearchStudy.recruitment", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "40,80" } ], "path": "ResearchStudy.recruitment", "short": "Target or actual group of participants enrolled in study", "definition": "Target or actual group of participants enrolled in study.", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" }, { "identity": "w5", "map": "FiveWs.subject[x]" }, { "identity": "BRIDG5.1", "map": "InterventionalStudyProtocol.interventionGroupQuantity" }, { "identity": "rim", "map": ".participation[typeCode=SBJ].role" }, { "identity": "w5", "map": "FiveWs.subject" } ] }, { "id": "ResearchStudy.recruitment.targetNumber", "path": "ResearchStudy.recruitment.targetNumber", "short": "Estimated total number of participants to be enrolled", "definition": "Estimated total number of participants to be enrolled.", "min": 0, "max": "1", "type": [ { "code": "unsignedInt" } ] }, { "id": "ResearchStudy.recruitment.actualNumber", "path": "ResearchStudy.recruitment.actualNumber", "short": "Actual total number of participants enrolled in study", "definition": "Actual total number of participants enrolled in study.", "min": 0, "max": "1", "type": [ { "code": "unsignedInt" } ] }, { "id": "ResearchStudy.recruitment.eligibility", "path": "ResearchStudy.recruitment.eligibility", "short": "Inclusion and exclusion criteria", "definition": "Inclusion and exclusion criteria.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ] } ] }, { "id": "ResearchStudy.recruitment.actualGroup", "path": "ResearchStudy.recruitment.actualGroup", "short": "Group of participants who were enrolled in study", "definition": "Group of participants who were enrolled in study.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ] } ], "isSummary": true, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" }, { "identity": "w5", "map": "FiveWs.subject[x]" }, { "identity": "BRIDG5.1", "map": "InterventionalStudyProtocol.interventionGroupQuantity" }, { "identity": "rim", "map": ".participation[typeCode=SBJ].role" }, { "identity": "w5", "map": "FiveWs.subject" } ] }, { "id": "ResearchStudy.comparisonGroup", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "840,90" } ], "path": "ResearchStudy.comparisonGroup", "short": "Defined path through the study for a subject", "definition": "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.", "comment": "In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.", "alias": [ "arm" ], "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "mapping": [ { "identity": "clinicaltrials-gov", "map": "Arms" }, { "identity": "BRIDG5.1", "map": "Arm" } ] }, { "id": "ResearchStudy.comparisonGroup.identifier[x]", "path": "ResearchStudy.comparisonGroup.identifier[x]", "short": "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily", "definition": "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.", "min": 0, "max": "1", "type": [ { "code": "uri" }, { "code": "Identifier" } ] }, { "id": "ResearchStudy.comparisonGroup.name", "path": "ResearchStudy.comparisonGroup.name", "short": "Label for study comparisonGroup", "definition": "Unique, human-readable label for this comparisonGroup of the study.", "min": 1, "max": "1", "type": [ { "code": "string" } ], "mapping": [ { "identity": "clinicaltrials-gov", "map": "Arm Label" }, { "identity": "BRIDG5.1", "map": "Arm.name" } ] }, { "id": "ResearchStudy.comparisonGroup.type", "path": "ResearchStudy.comparisonGroup.type", "short": "Categorization of study comparisonGroup", "definition": "Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyArmType" } ], "strength": "extensible", "description": "desc.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-arm-type" }, "mapping": [ { "identity": "clinicaltrials-gov", "map": "Arm Type" }, { "identity": "BRIDG5.1", "map": "Arm.typeCode" } ] }, { "id": "ResearchStudy.comparisonGroup.description", "path": "ResearchStudy.comparisonGroup.description", "short": "Short explanation of study path", "definition": "A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ], "mapping": [ { "identity": "clinicaltrials-gov", "map": "Arm Description" }, { "identity": "BRIDG5.1", "map": "Arm.description" } ] }, { "id": "ResearchStudy.comparisonGroup.intendedExposure", "path": "ResearchStudy.comparisonGroup.intendedExposure", "short": "Interventions or exposures in this comparisonGroup or cohort", "definition": "Interventions or exposures in this comparisonGroup or cohort.", "requirements": "this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/EvidenceVariable" ] } ] }, { "id": "ResearchStudy.comparisonGroup.observedGroup", "path": "ResearchStudy.comparisonGroup.observedGroup", "short": "Group of participants who were enrolled in study comparisonGroup", "definition": "Group of participants who were enrolled in study comparisonGroup.", "requirements": "This is necessary to relate comparisonGroups to actual groups", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Group" ] } ] }, { "id": "ResearchStudy.objective", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "840,220" } ], "path": "ResearchStudy.objective", "short": "A goal for the study", "definition": "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.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "mapping": [ { "identity": "BRIDG5.1", "map": "StudyObjective" } ] }, { "id": "ResearchStudy.objective.name", "path": "ResearchStudy.objective.name", "short": "Label for the objective", "definition": "Unique, human-readable label for this objective of the study.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "mapping": [ { "identity": "BRIDG5.1", "map": "No BRIDG mapping (BRIDG has a description, but not a name)" } ] }, { "id": "ResearchStudy.objective.type", "path": "ResearchStudy.objective.type", "short": "primary | secondary | exploratory", "definition": "The kind of study objective.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyObjectiveType" } ], "strength": "preferred", "description": "Codes for the kind of study objective.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type" }, "mapping": [ { "identity": "BRIDG5.1", "map": "StudyObjective.typeCode" } ] }, { "id": "ResearchStudy.objective.description", "path": "ResearchStudy.objective.description", "short": "Description of the objective", "definition": "Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).", "min": 0, "max": "1", "type": [ { "code": "markdown" } ] }, { "id": "ResearchStudy.outcomeMeasure", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "840,310" } ], "path": "ResearchStudy.outcomeMeasure", "short": "An outcome or planned variable to measure during the study", "definition": "An outcome or planned variable to measure during the study.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.outcomeMeasure.name", "path": "ResearchStudy.outcomeMeasure.name", "short": "Label for the outcome", "definition": "Label for the outcome.", "min": 0, "max": "1", "type": [ { "code": "string" } ] }, { "id": "ResearchStudy.outcomeMeasure.type", "path": "ResearchStudy.outcomeMeasure.type", "short": "primary | secondary | exploratory", "definition": "The parameter or characteristic being assessed as one of the values by which the study is assessed.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyObjectiveType" } ], "strength": "preferred", "description": "defn.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-type" } }, { "id": "ResearchStudy.outcomeMeasure.description", "path": "ResearchStudy.outcomeMeasure.description", "short": "Description of the outcome", "definition": "Description of the outcome.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ] }, { "id": "ResearchStudy.outcomeMeasure.reference", "path": "ResearchStudy.outcomeMeasure.reference", "short": "Structured outcome definition", "definition": "Structured outcome definition.", "min": 0, "max": "1", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/EvidenceVariable" ] } ] }, { "id": "ResearchStudy.result", "path": "ResearchStudy.result", "short": "Link to results generated during the study", "definition": "Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/EvidenceReport", "http://hl7.org/fhir/StructureDefinition/Citation", "http://hl7.org/fhir/StructureDefinition/DiagnosticReport" ] } ], "isSummary": true }, { "id": "ResearchStudy.webLocation", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "840,410" } ], "path": "ResearchStudy.webLocation", "short": "Archive location for the study", "definition": "A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ] }, { "id": "ResearchStudy.webLocation.classifier", "path": "ResearchStudy.webLocation.classifier", "short": "registry-page|recruitment-page|contact-page", "definition": "Describes the nature of the location being specified.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ArtifactUrlClassifier" } ], "strength": "example", "description": "defn.", "valueSet": "http://hl7.org/fhir/ValueSet/artifact-url-classifier" } }, { "id": "ResearchStudy.webLocation.url", "path": "ResearchStudy.webLocation.url", "short": "The location address", "definition": "The location address.", "min": 1, "max": "1", "type": [ { "code": "uri" } ] } ] } }