{
  "resourceType": "StructureDefinition",
  "id": "ResearchSubject",
  "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": "patient"
    },
    {
      "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/ResearchSubject",
  "version": "4.6.0",
  "name": "ResearchSubject",
  "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 physical entity which is the primary unit of operational and/or administrative interest in a study.",
  "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"
    }
  ],
  "kind": "resource",
  "abstract": false,
  "type": "ResearchSubject",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
  "derivation": "specialization",
  "differential": {
    "element": [
      {
        "id": "ResearchSubject",
        "path": "ResearchSubject",
        "short": "Physical entity which is the primary unit of interest in the study",
        "definition": "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
        "comment": "Need to make sure we encompass public health studies.",
        "alias": [
          "Study Subject"
        ],
        "min": 0,
        "max": "*",
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "StudySubject"
          },
          {
            "identity": "v2",
            "map": "OBX"
          },
          {
            "identity": "rim",
            "map": "Observation[classCode=CLNTRL, moodCode=EVN]"
          },
          {
            "identity": "w5",
            "map": "clinical.diagnostics"
          }
        ]
      },
      {
        "id": "ResearchSubject.identifier",
        "path": "ResearchSubject.identifier",
        "short": "Business Identifier for research subject in a study",
        "definition": "Identifiers assigned to this research subject for a study.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.identifier"
          },
          {
            "identity": "BRIDG5.1",
            "map": "StudySubject > Subject.identifier"
          },
          {
            "identity": "rim",
            "map": ".identifier"
          }
        ]
      },
      {
        "id": "ResearchSubject.status",
        "path": "ResearchSubject.status",
        "short": "draft | active | retired | unknown",
        "definition": "The publication state of the resource (not of the subject).",
        "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": "StudySubject.statusCode"
          },
          {
            "identity": "rim",
            "map": ".status"
          }
        ]
      },
      {
        "id": "ResearchSubject.progress",
        "path": "ResearchSubject.progress",
        "short": "Subject status",
        "definition": "The current state (status) of the subject and resons for status change where appropriate.",
        "comment": "This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone.  In strict terms a milestone is a point of time event that results in a change from one state to another.  The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description.  For instance \"Randomised\" and \"Visit 1\" may be different milestones but the state remains at \"on study\" after each of them. \n\nIt is likely that more than one \"state\" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "BackboneElement"
          }
        ]
      },
      {
        "id": "ResearchSubject.progress.type",
        "path": "ResearchSubject.progress.type",
        "short": "state | milestone",
        "definition": "Identifies the aspect of the subject's journey that the state refers to.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "ResearchSubjectStateType"
            }
          ],
          "strength": "example",
          "description": "Identifies the kind of state being refered to.",
          "valueSet": "http://hl7.org/fhir/ValueSet/research-subject-state-type"
        }
      },
      {
        "id": "ResearchSubject.progress.subjectState",
        "path": "ResearchSubject.progress.subjectState",
        "short": "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
        "definition": "The current state of the subject.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "ResearchSubjectProgresss"
            }
          ],
          "strength": "required",
          "description": "Indicates the progression of a study subject through a study.",
          "valueSet": "http://hl7.org/fhir/ValueSet/research-subject-progress"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.status"
          },
          {
            "identity": "BRIDG5.1",
            "map": "StudySubject.statusCode"
          },
          {
            "identity": "rim",
            "map": ".status"
          }
        ]
      },
      {
        "id": "ResearchSubject.progress.milestone",
        "path": "ResearchSubject.progress.milestone",
        "short": "SignedUp | Screened | Randomized",
        "definition": "The milestones the subject has passed through.",
        "comment": "There can be multiple entries but it is also valid to just have the most recent.  This should npt be rlied upon as the full path the subject has taken.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "ResearchSubjectMilestone"
            }
          ],
          "strength": "example",
          "description": "Indicates the progression of a study subject through the study milestones.",
          "valueSet": "http://hl7.org/fhir/ValueSet/research-subject-milestone"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.status"
          },
          {
            "identity": "BRIDG5.1",
            "map": "StudySubject.statusCode"
          }
        ]
      },
      {
        "id": "ResearchSubject.progress.reason",
        "path": "ResearchSubject.progress.reason",
        "short": "State change reason",
        "definition": "The reason for the state change.  If coded it should follow the formal subject state model.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "StateChangeReason"
            }
          ],
          "strength": "example",
          "description": "Indicates why the state of the subject changed.",
          "valueSet": "http://hl7.org/fhir/ValueSet/state-change-reason"
        }
      },
      {
        "id": "ResearchSubject.progress.startDate",
        "path": "ResearchSubject.progress.startDate",
        "short": "State change date",
        "definition": "The date when the new status started.",
        "comment": "This is NOT the date the change in state was recorded.",
        "requirements": "This was originally defined as the date when the change in status occurred.  This assumed all                      states were recorded which is not true.  Hence the need to track the end of the state.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "dateTime"
          }
        ]
      },
      {
        "id": "ResearchSubject.progress.endDate",
        "path": "ResearchSubject.progress.endDate",
        "short": "State change date",
        "definition": "The date when the state ended.",
        "requirements": "See the requirement on the start date.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "dateTime"
          }
        ]
      },
      {
        "id": "ResearchSubject.period",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/todo",
            "valueString": ".effectiveTime."
          }
        ],
        "path": "ResearchSubject.period",
        "short": "Start and end of participation",
        "definition": "The dates the subject began and ended their participation in the study.",
        "alias": [
          "timing"
        ],
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Period"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "PerformedStudySubjectMilestone.studyReferenceDateRange"
          }
        ]
      },
      {
        "id": "ResearchSubject.study",
        "path": "ResearchSubject.study",
        "short": "Study subject is part of",
        "definition": "Reference to the study the subject is participating in.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "StudySubjectProtocolVersionRelationship"
          }
        ]
      },
      {
        "id": "ResearchSubject.subject",
        "path": "ResearchSubject.subject",
        "short": "Who or what is part of study",
        "definition": "The record of the person, animal or other entity involved in the study.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Patient",
              "http://hl7.org/fhir/StructureDefinition/Group",
              "http://hl7.org/fhir/StructureDefinition/Specimen",
              "http://hl7.org/fhir/StructureDefinition/Device",
              "http://hl7.org/fhir/StructureDefinition/Medication",
              "http://hl7.org/fhir/StructureDefinition/Substance",
              "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "StudySubject"
          }
        ]
      },
      {
        "id": "ResearchSubject.assignedArm",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/todo",
            "valueString": "This ought to have an identifer as well as a name\n\nOR - allocation is to a Group which is part of a planDefinition which represents an Arm."
          }
        ],
        "path": "ResearchSubject.assignedArm",
        "short": "What path should be followed",
        "definition": "The name of the arm in the study the subject is expected to follow as part of this study.",
        "comment": "Maybe this is really PlanDefinition.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
          }
        ]
      },
      {
        "id": "ResearchSubject.actualArm",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/todo",
            "valueString": "This ought to have an identifer as well as a name\n\nOR - allocation is to a Group which is part of a planDefinition which represents an Arm."
          }
        ],
        "path": "ResearchSubject.actualArm",
        "short": "What path was followed",
        "definition": "The name of the arm in the study the subject actually followed as part of this study.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
          }
        ]
      },
      {
        "id": "ResearchSubject.consent",
        "path": "ResearchSubject.consent",
        "short": "Agreement to participate in study",
        "definition": "A record of the patient's informed agreement to participate in the study.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Consent"
            ]
          }
        ],
        "mapping": [
          {
            "identity": "BRIDG5.1",
            "map": "ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."
          }
        ]
      }
    ]
  }
}