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Source1

{
  "resourceType": "ResearchStudy",
  "id": "Exemplar-Protocol-Summary",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "extension": [
        {
          "url": "objectiveAndEstimandSummary",
          "valueString": "The primary objective of this study is to see if Inhaled Exoticillin achieves similar or better results compared to intramuscular Exoticillin when treating Bronchtis in Japanese Patients who also have Iatrogenic Diabetes Mellitus.  The seconday objective is to evaluate the cost differences in treatment.\nEvaluation will be by recording the average days to recovery, the total combined cost of medication and cost of hospital stay."
        },
        {
          "url": "interventionModel",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C82639",
                "display": "Parallel Group"
              }
            ]
          }
        },
        {
          "url": "populationType",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C218503",
                "display": "With Disease"
              }
            ]
          }
        },
        {
          "url": "controlType",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C218505",
                "display": "Different Dose or Regimen"
              }
            ]
          }
        },
        {
          "url": "comparator",
          "valueReference": {
            "reference": "MedicinalProductDefinition/Exemplar-ComparatorProduct"
          }
        },
        {
          "url": "minimumAge",
          "valueQuantity": {
            "value": 18,
            "unit": "Years",
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code": "C29848"
          }
        },
        {
          "url": "maximumAge",
          "valueQuantity": {
            "value": 55,
            "unit": "Years",
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code": "C29848"
          }
        },
        {
          "url": "interventionAssignmentMethod",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C25196",
                "display": "Randomisation"
              }
            ]
          }
        },
        {
          "url": "randomisationType",
          "valueCodeableConcept": {
            "text": "block randomisation"
          }
        },
        {
          "url": "otherInterventionAssignmentMethod",
          "valueString": ""
        },
        {
          "url": "stratificationIndicator",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C49488",
                "display": "Yes"
              }
            ]
          }
        },
        {
          "url": "siteDistribution",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C217005",
                "display": "Multicentre"
              }
            ]
          }
        },
        {
          "url": "siteGeographicScope",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C217007",
                "display": "Multiple Countries "
              }
            ]
          }
        },
        {
          "url": "masterProtocolIndicator",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C49487",
                "display": "No"
              }
            ]
          }
        },
        {
          "url": "drug-DeviceCombinationProductIndicator",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C49488",
                "display": "Yes"
              }
            ]
          }
        },
        {
          "url": "adaptiveTrialDesignIndicator",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C49487",
                "display": "No"
              }
            ]
          }
        },
        {
          "url": "numberOfArms",
          "valueInteger": 2
        },
        {
          "url": "trialBlindSchema",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C187674",
                "display": "Observer Blind"
              }
            ]
          }
        },
        {
          "url": "blindedRoles",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C142710",
                "display": "Participant"
              }
            ]
          }
        },
        {
          "url": "blindedRoles",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C17445",
                "display": "Care Provider "
              }
            ]
          }
        },
        {
          "url": "targetOrMaximum",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://HL7Vulcan.org/UDP/target",
                "code": "T",
                "display": "Target"
              }
            ]
          }
        },
        {
          "url": "numberOfParticipants",
          "valueInteger": 200
        },
        {
          "url": "alternateDescriptionOfPlannedDurationOfTrialIntervention",
          "valueString": "Will depend on response to treatment"
        },
        {
          "url": "totalPlannedDurationOfTrialParticipation",
          "valueQuantity": {
            "value": 3,
            "unit": "Months",
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code": "C29846"
          }
        },
        {
          "url": "independentCommittees",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C142578",
                "display": "Independent Data Monitoring Committee"
              }
            ]
          }
        },
        {
          "url": "independentCommittees",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C17649",
                "display": "Other"
              }
            ]
          }
        },
        {
          "url": "otherCommittees",
          "valueString": "Exemplar Monitoring Board"
        },
        {
          "url": "trialSchema"
        },
        {
          "url": "schemaNotes",
          "valueString": "Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus."
        },
        {
          "url": "scheduleofActivities"
        },
        {
          "url": "populationDiagnosisOrCondition"
        },
        {
          "url": "unitsOfMinimumAge"
        },
        {
          "url": "unitsOfMaximumAge"
        },
        {
          "url": "totalPlannedDurationOfTrialIntervention"
        },
        {
          "url": "alternateDescriptionOfPlannedDurationOfTrialParticipation"
        },
        {
          "url": "additionalDescriptionofDuration"
        }
      ],
      "url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"
    },
    {
      "extension": [
        {
          "url": "originalProtocol"
        },
        {
          "url": "versionDate"
        }
      ],
      "url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
    }
  ],
  "identifier": [
    {
      "use": "usual",
      "type": {
        "coding": [
          {
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code": "C132351",
            "display": "Sponsor Protocol Identifier"
          }
        ]
      },
      "system": "https://exemplarSponsor.com/sponsor-identifier",
      "value": "ABC-Exemplar"
    }
  ],
  "status": "active",
  "focus": [
    {
      "reference": {
        "reference": "MedicinalProductDefinition/Exemplar-MedicinalProduct"
      }
    }
  ],
  "condition": [
    {
      "coding": [
        {
          "system": "http://snomed.info/sct",
          "code": "32398004",
          "display": "Bronchitis (disorder)"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://snomed.info/sct",
          "code": "1137328006",
          "display": "Iatrogenic hypoglycaemia"
        }
      ]
    }
  ]
}