### ----------------------------------------------------
### -- FHIR
### -- Licenses: Artistic-2.0
### -- Authors: Hugh Simpson
### -- File: t/resources/structureDefinition/ResearchStudy.json
### ----------------------------------------------------
### -- Chunk 8 of 8
CompanionStudyRelationship"
      },
      {
        "identity" : "rim",
        "map" : ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
      }]
    },
    {
      "id" : "ResearchStudy.status",
      "path" : "ResearchStudy.status",
      "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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn",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" : "The current state 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" : "ResearchStudyStatus"
        }],
        "strength" : "required",
        "description" : "Codes that convey the current status of the research study.",
        "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-status|4.0.0"
      },
      "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's 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",
      "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" : "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.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.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.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.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.description",
      "path" : "ResearchStudy.description",
      "short" : "What this is study doing",
      "definition" : "A full description of how the study is being conducted.",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "markdown"
      }],
      "mapping" : [{
        "identity" : "clinicaltrials-gov",
        "map" : "Detailed Description"
      },
      {
        "identity" : "BRIDG5.1",
        "map" : "StudyProtocolDocumentVersion.publicDescription"
      }]
    },
    {
      "id" : "ResearchStudy.enrollment",
      "path" : "ResearchStudy.enrollment",
      "short" : "Inclusion & exclusion criteria",
      "definition" : "Reference to a Group that defines the criteria for and quantity of subjects participating in the study.  E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\".",
      "comment" : "The Group referenced should not generally enumerate specific subjects.  Subjects will be linked to the study using the ResearchSubject resource.",
      "alias" : ["patient"],
      "min" : 0,
      "max" : "*",
      "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.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.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"]
      }],
      "isSummary" : true,
      "mapping" : [{
        "identity" : "clinicaltrials-gov",
        "map" : "Facility"
      },
      {
        "identity" : "w5",
        "map" : "FiveWs.where[x]"
      },
      {
        "identity" : "BRIDG5.1",
        "map" : "PlannedStudySite; StudySite"
      }]
    },
    {
      "id" : "ResearchStudy.reasonStopped",
      "path" : "ResearchStudy.reasonStopped",
      "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.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.arm",
      "path" : "ResearchStudy.arm",
      "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.",
      "min" : 0,
      "max" : "*",
      "type" : [{
        "code" : "BackboneElement"
      }],
      "mapping" : [{
        "identity" : "clinicaltrials-gov",
        "map" : "Arms"
      },
      {
        "identity" : "BRIDG5.1",
        "map" : "Arm"
      }]
    },
    {
      "id" : "ResearchStudy.arm.name",
      "path" : "ResearchStudy.arm.name",
      "short" : "Label for study arm",
      "definition" : "Unique, human-readable label for this arm 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.arm.type",
      "path" : "ResearchStudy.arm.type",
      "short" : "Categorization of study arm",
      "definition" : "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "mapping" : [{
        "identity" : "clinicaltrials-gov",
        "map" : "Arm Type"
      },
      {
        "identity" : "BRIDG5.1",
        "map" : "Arm.typeCode"
      }]
    },
    {
      "id" : "ResearchStudy.arm.description",
      "path" : "ResearchStudy.arm.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 arm.",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "string"
      }],
      "mapping" : [{
        "identity" : "clinicaltrials-gov",
        "map" : "Arm Description"
      },
      {
        "identity" : "BRIDG5.1",
        "map" : "Arm.description"
      }]
    },
    {
      "id" : "ResearchStudy.objective",
      "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"
      }]
    }]
  }
}


