{
  "description": "This is a set of terms for study design characteristics.",
  "compose": {
    "include": [ {
      "system": "http://hl7.org/fhir/study-design"
    } ]
  },
  "_filename": "ValueSet-study-design.json",
  "package_name": "hl7.fhir.r6.expansions",
  "date": "2022-08-24T12:40:00+00:00",
  "meta": {
    "profile": [ "http://hl7.org/fhir/StructureDefinition/shareablevalueset" ],
    "lastUpdated": "2024-08-12T08:52:12+00:00"
  },
  "publisher": "HL7 (FHIR Project)",
  "jurisdiction": [ {
    "coding": [ {
      "code": "001",
      "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "display": "World"
    } ]
  } ],
  "name": "StudyDesign",
  "type": null,
  "experimental": "true",
  "resourceType": "ValueSet",
  "expansion": {
    "total": 72,
    "offset": 0,
    "contains": [ {
      "code": "SEVCO:01001",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Interventional research",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Interventional study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Interventional study design"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "interventional primary research"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "international method of research"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "experimental research"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "experimental study"
      } ]
    }, {
      "code": "SEVCO:01003",
      "system": "http://hl7.org/fhir/study-design",
      "display": "randomized assignment",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Interventional research with randomized assignment"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Randomized trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Randomized controlled trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "RCT"
      } ]
    }, {
      "code": "SEVCO:01006",
      "system": "http://hl7.org/fhir/study-design",
      "display": "simple randomization",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Unrestricted Randomization"
      } ]
    }, {
      "code": "SEVCO:01007",
      "system": "http://hl7.org/fhir/study-design",
      "display": "stratified randomization"
    }, {
      "code": "SEVCO:01008",
      "system": "http://hl7.org/fhir/study-design",
      "display": "block randomization"
    }, {
      "code": "SEVCO:01009",
      "system": "http://hl7.org/fhir/study-design",
      "display": "adaptive randomization"
    }, {
      "code": "SEVCO:01005",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Non-randomized assignment",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Interventional research with non-randomized assignment"
      } ]
    }, {
      "code": "SEVCO:01004",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Quasi-Randomized assignment"
    }, {
      "code": "SEVCO:01029",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Clinical trial"
    }, {
      "code": "SEVCO:01041",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Pragmatic clinical trial",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Pragmatic trial"
      } ]
    }, {
      "code": "SEVCO:01038",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Expanded Access study",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Compassionate use trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Compassionate use study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Expanded access trial"
      } ]
    }, {
      "code": "SEVCO:01030",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Phase 1 trial",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase I trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 1 study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "phase I clinical trial"
      } ]
    }, {
      "code": "SEVCO:01031",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Exploratory investigational new drug study",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 0 study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Pre-clinical trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Exploratory IND study"
      } ]
    }, {
      "code": "SEVCO:01032",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Phase 1/Phase 2 trial",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase I/II trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 1-2 trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 1/2 trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Trial phase 1-2"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Trial phase 1/2"
      } ]
    }, {
      "code": "SEVCO:01033",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Phase 2 trial",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase II trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "phase 2 study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Exploratory clinical study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "phase II clinical trial"
      } ]
    }, {
      "code": "SEVCO:01034",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Phase 2/Phase 3 trial",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase II/III trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 2-3 trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 2/3 trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Trial phase 2-3"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Trial phase 2/3"
      } ]
    }, {
      "code": "SEVCO:01035",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Phase 3 Trial",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase III trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "phase 3 study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Confirmatory clinical study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "phase III clinical trial"
      } ]
    }, {
      "code": "SEVCO:01036",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Post-marketing study",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase IV trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 4 trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Phase 4 study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Trial phase 4"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Post-approval study"
      } ]
    }, {
      "code": "SEVCO:01002",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Observational research",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Observational Study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Observational Study Design"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Observational primary research"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "observational method of research"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Non-interventional research"
      } ]
    }, {
      "code": "SEVCO:01037",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Post-Marketing Surveillance study",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Postmarketing evaluation study"
      } ]
    }, {
      "code": "SEVCO:01010",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Comparative study design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Comparative research"
      } ]
    }, {
      "code": "SEVCO:01011",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Parallel cohort design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Concurrent cohort study"
      } ]
    }, {
      "code": "SEVCO:01012",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Crossover cohort design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Crossover study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Crossover trial"
      } ]
    }, {
      "code": "SEVCO:01024",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Controlled crossover cohort design"
    }, {
      "code": "SEVCO:01025",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Single-arm crossover design"
    }, {
      "code": "SEVCO:01013",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Case control design"
    }, {
      "code": "SEVCO:01014",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Matching for comparison",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Matched study design"
      } ]
    }, {
      "code": "SEVCO:01020",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Family study design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Familial study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Family study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Family based study"
      } ]
    }, {
      "code": "SEVCO:01021",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Twin study design"
    }, {
      "code": "SEVCO:01015",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Cluster as unit of allocation",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Clustering for comparison"
      } ]
    }, {
      "code": "SEVCO:01023",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Non-comparative study design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Non-comparative research"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Descriptive study"
      } ]
    }, {
      "code": "SEVCO:01016",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Uncontrolled cohort design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Single cohort design"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Case series design"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Non-controlled cohort design"
      } ]
    }, {
      "code": "SEVCO:01017",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Case report",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Case study"
      } ]
    }, {
      "code": "SEVCO:01022",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Population-based design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Population study"
      } ]
    }, {
      "code": "SEVCO:01044",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Ecological design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Ecologic study"
      } ]
    }, {
      "code": "SEVCO:01027",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Cross sectional data collection ",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Cross-sectional study"
      } ]
    }, {
      "code": "SEVCO:01028",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Longitudinal data collection",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Longitudinal study"
      } ]
    }, {
      "code": "SEVCO:01018",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Time series design",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Multiple time point comparison"
      } ]
    }, {
      "code": "SEVCO:01019",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Before and after comparison",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Before and After design"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Pre-Post Design"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Before-After Comparison"
      } ]
    }, {
      "code": "SEVCO:01045",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Primary data collection",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Study-generated data collection"
      } ]
    }, {
      "code": "SEVCO:01026",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Real world data collection",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD collection"
      } ]
    }, {
      "code": "SEVCO:01039",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Real world data collection from healthcare records",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD collection from clinical care records"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD from health care records"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD from healthcare delivery records"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Real world data collection from medical records"
      } ]
    }, {
      "code": "SEVCO:01050",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Real world data collection from personal health records",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Real world data collection from personal care records"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD collection from personal medical records"
      } ]
    }, {
      "code": "SEVCO:01040",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Real world data collection from healthcare financing records",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD collection from healthcare financing records"
      } ]
    }, {
      "code": "SEVCO:01048",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Real world data collection from testing procedures",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD collection from testing procedures"
      } ]
    }, {
      "code": "SEVCO:01046",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Real world data collection from monitoring procedures",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "RWD collection from monitoring procedures"
      } ]
    }, {
      "code": "SEVCO:01049",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Secondary data collection from prior research"
    }, {
      "code": "SEVCO:01042",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Secondary data collection from a registry"
    }, {
      "code": "SEVCO:01051",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Multisite data collection"
    }, {
      "code": "SEVCO:01086",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Quantitative analysis"
    }, {
      "code": "SEVCO:01087",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Qualitative analysis"
    }, {
      "code": "SEVCO:01060",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Blinding of study participants",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Masking of study participants"
      } ]
    }, {
      "code": "SEVCO:01061",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Blinding of intervention providers",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Masking of intervention providers"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Blinding of intervention deliverers"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Masking of intervention deliverers"
      } ]
    }, {
      "code": "SEVCO:01062",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Blinding of outcome assessors",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Masking of outcome assessors"
      } ]
    }, {
      "code": "SEVCO:01063",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Blinding of data analysts",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Masking of data analysts"
      } ]
    }, {
      "code": "SEVCO:01064",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Allocation concealment",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Blinding of randomization assignment"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Masking of randomization assignment"
      } ]
    }, {
      "code": "SEVCO:01043",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Multicentric",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Multi-institutional study"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Multicenter trial"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Multicenter study"
      } ]
    }, {
      "code": "SEVCO:01052",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Includes patient-reported outcome",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "PRO"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes patient-reported outcomes"
      } ]
    }, {
      "code": "SEVCO:01053",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Includes patient-centered outcome",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes patient-oriented outcome"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes patient-important outcome"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes patient-relevant outcome"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes clinical outcome"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes patient-centered outcome measure"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes clinical outcome measure"
      } ]
    }, {
      "code": "SEVCO:01054",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Includes disease-oriented outcome",
      "designation": [ {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes disease-oriented outcome measure"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes surrogate outcome"
      }, {
        "use": {
          "display": "Alternative term"
        },
        "value": "Includes surrogate outcome measure"
      } ]
    }, {
      "code": "SEVCO:01085",
      "system": "http://hl7.org/fhir/study-design",
      "display": "Includes process measure",
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