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Codesystem-research-study-classifiers.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw JSON (canonical form + also see JSON Format Specification)

Definition for Code SystemResearchStudyClassifiers

{
  "resourceType" : "CodeSystem",
  "id" : "research-study-classifiers",
  "meta" : {
    "lastUpdated" : "2022-08-09T15:51:58.790+11:00",
    "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div>!-- Snipped for Brevity --></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  },
  {
    "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/research-study-classifiers",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.1.1686"
  }],
  "version" : "4.6.0",
  "name" : "ResearchStudyClassifiers",
  "title" : "ResearchStudy Classifiers Code System",
  "status" : "draft",
  "experimental" : false,
  "date" : "2022-05-15T16:55:11.085+11:00",
  "publisher" : "HL7 (FHIR Project)",
  "contact" : [{
    "telecom" : [{
      "system" : "url",
      "value" : "http://hl7.org/fhir"
    },
    {
      "system" : "email",
      "value" : "fhir@lists.hl7.org"
    }]
  }],
  "description" : "Codes for use in ResearchStudy Resource. This resource (this entire set of content) is being used for active development of a ResearchStudyClassifiers CodeSystem for use for supporting multiple value sets in the FHIR ResearchStudy StructureDefinition.",
  "caseSensitive" : true,
  "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-classifiers",
  "content" : "complete",
  "concept" : [{
    "code" : "research-study-label-type",
    "display" : "Research Study Label Type",
    "concept" : [{
      "code" : "short",
      "display" : "Short",
      "definition" : "A short form of the name - what is used in everyday conversation."
    },
    {
      "code" : "public",
      "display" : "Public",
      "definition" : "A name that is understandable to non-technical readers."
    },
    {
      "code" : "scientific",
      "display" : "Scientific",
      "definition" : "A full name that is suitable for use in an academic or technical setting."
    }]
  },
  {
    "code" : "research-study-classifier",
    "display" : "Research Study Classifier",
    "concept" : [{
      "code" : "research-study-prim-purp-type",
      "display" : "Research Study Primary Purpose Type",
      "concept" : [{
        "code" : "treatment",
        "display" : "Treatment",
        "definition" : "One or more interventions are being evaluated for treating a disease, syndrome, or condition."
      },
      {
        "code" : "prevention",
        "display" : "Prevention",
        "definition" : "One or more interventions are being assessed for preventing the development of a specific disease or health condition."
      },
      {
        "code" : "diagnostic",
        "display" : "Diagnostic",
        "definition" : "One or more interventions are being evaluated for identifying a disease or health condition."
      },
      {
        "code" : "supportive-care",
        "display" : "Supportive Care",
        "definition" : "One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function."
      },
      {
        "code" : "screening",
        "display" : "Screening",
        "definition" : "One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor."
      },
      {
        "code" : "health-services-research",
        "display" : "Health Services Research",
        "definition" : "One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare."
      },
      {
        "code" : "basic-science",
        "display" : "Basic Science",
        "definition" : "One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention)."
      },
      {
        "code" : "device-feasibility",
        "display" : "Device Feasibility",
        "definition" : "An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial."
      }]
    },
    {
      "code" : "research-study-phase",
      "display" : "Research Study Phase",
      "concept" : [{
        "code" : "n-a",
        "display" : "N/A",
        "definition" : "Trials without phases (for example, studies of devices or behavioral interventions)."
      },
      {
        "code" : "early-phase-1",
        "display" : "Early Phase 1",
        "definition" : "Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0."
      },
      {
        "code" : "phase-1",
        "display" : "Phase 1",
        "definition" : "Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients."
      },
      {
        "code" : "phase-1-phase-2",
        "display" : "Phase 1/Phase 2",
        "definition" : "Trials that are a combination of phases 1 and 2."
      },
      {
        "code" : "phase-2",
        "display" : "Phase 2",
        "definition" : "Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks."
      },
      {
        "code" : "phase-2-phase-3",
        "display" : "Phase 2/Phase 3",
        "definition" : "Trials that are a combination of phases 2 and 3."
      },
      {
        "code" : "phase-3",
        "display" : "Phase 3",
        "definition" : "Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug."
      },
      {
        "code" : "phase-4",
        "display" : "Phase 4",
        "definition" : "Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use."
      }]
    },
    {
      "code" : "research-study-focus-type",
      "display" : "Research Study Focus Type",
      "concept" : [{
        "code" : "medication",
        "display" : "Medication"
      },
      {
        "code" : "device",
        "display" : "Device"
      },
      {
        "code" : "intervention",
        "display" : "Intervention"
      },
      {
        "code" : "factor",
        "display" : "Factor"
      }]
    }]
  },
  {
    "code" : "research-study-classification-type",
    "display" : "Research Study Classification Type",
    "concept" : [{
      "code" : "phase",
      "display" : "Phase"
    },
    {
      "code" : "category",
      "display" : "Category"
    },
    {
      "code" : "keyword",
      "display" : "Keyword"
    }]
  },
  {
    "code" : "research-study-party-organization-type",
    "display" : "Research Study Party Organization Type",
    "concept" : [{
      "code" : "nih",
      "display" : "NIH"
    },
    {
      "code" : "fda",
      "display" : "FDA"
    }]
  },
  {
    "code" : "research-study-party-role",
    "display" : "Research Study Party Role",
    "concept" : [{
      "code" : "sponsor",
      "display" : "Sponsor"
    },
    {
      "code" : "lead-sponsor",
      "display" : "Lead Sponsor"
    },
    {
      "code" : "sponsor-investigator",
      "display" : "Sponsor-Investigator"
    },
    {
      "code" : "primary-investigator",
      "display" : "Primary Investigator"
    },
    {
      "code" : "collaborator",
      "display" : "Collaborator"
    },
    {
      "code" : "funding-source",
      "display" : "Funding Source"
    },
    {
      "code" : "recruitment-contact",
      "display" : "Recruitment Contact"
    },
    {
      "code" : "sub-investigator",
      "display" : "Sub-investigator"
    },
    {
      "code" : "study-director",
      "display" : "Study Director"
    },
    {
      "code" : "study-chair",
      "display" : "Study Chair"
    }]
  },
  {
    "code" : "research-study-status",
    "display" : "Research Study Status",
    "concept" : [{
      "code" : "overall-study",
      "display" : "Overall study",
      "definition" : "Used for documenting the start and end of the overall study, distinct from progress states."
    },
    {
      "code" : "active",
      "display" : "Active",
      "definition" : "Study is opened for accrual."
    },
    {
      "code" : "active-but-not-recruiting",
      "display" : "Active, not recruiting",
      "definition" : "The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled."
    },
    {
      "code" : "administratively-completed",
      "display" : "Administratively Completed",
      "definition" : "Study is completed prematurely and will not resume; patients are no longer examined nor treated."
    },
    {
      "code" : "approved",
      "display" : "Approved",
      "definition" : "Protocol is approved by the review board."
    },
    {
      "code" : "closed-to-accrual",
      "display" : "Closed to Accrual",
      "definition" : "Study is closed for accrual; patients can be examined and treated."
    },
    {
      "code" : "closed-to-accrual-and-intervention",
      "display" : "Closed to Accrual and Intervention",
      "definition" : "Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study."
    },
    {
      "code" : "completed",
      "display" : "Completed",
      "definition" : "The study closed according to the study plan. There will be no further treatments, interventions or data collection."
    },
    {
      "code" : "disapproved",
      "display" : "Disapproved",
      "definition" : "Protocol was disapproved by the review board."
    },
    {
      "code" : "enrolling-by-invitation",
      "display" : "Enrolling by invitation",
      "definition" : "The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate."
    },
    {
      "code" : "in-review",
      "display" : "In Review",
      "definition" : "Protocol is submitted to the review board for approval."
    },
    {
      "code" : "not-yet-recruiting",
      "display" : "Not yet recruiting",
      "definition" : "The study has not started recruiting participants."
    },
    {
      "code" : "recruiting",
      "display" : "Recruiting",
      "definition" : "The study is currently recruiting participants."
    },
    {
      "code" : "temporarily-closed-to-accrual",
      "display" : "Temporarily Closed to Accrual",
      "definition" : "Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated."
    },
    {
      "code" : "temporarily-closed-to-accrual-and-intervention",
      "display" : "Temporarily Closed to Accrual and Intervention",
      "definition" : "Study is temporarily closed for accrual and intervention and potentially can be resumed in the future."
    },
    {
      "code" : "terminated",
      "display" : "Terminated",
      "definition" : "The study has stopped early and will not start again. Participants are no longer being examined or treated."
    },
    {
      "code" : "withdrawn",
      "display" : "Withdrawn",
      "definition" : "Protocol was withdrawn by the lead organization."
    }]
  },
  {
    "code" : "research-study-registration-activity",
    "display" : "Research Study Registration Activity",
    "concept" : [{
      "code" : "record-verification",
      "display" : "Record Verification",
      "definition" : "Record has been verified."
    },
    {
      "code" : "primary-outcome-data-collection",
      "display" : "Primary outcome data collection"
    },
    {
      "code" : "registration-submission",
      "display" : "Registration submission"
    },
    {
      "code" : "registration-submission-qc",
      "display" : "Registration submission Quality Check"
    },
    {
      "code" : "registration-posting",
      "display" : "Registration posting"
    },
    {
      "code" : "results-submission",
      "display" : "Results submission"
    },
    {
      "code" : "results-submission-qc",
      "display" : "Results submission Quality Check"
    },
    {
      "code" : "results-posting",
      "display" : "Results posting"
    },
    {
      "code" : "disposition-submission",
      "display" : "Disposition submission"
    },
    {
      "code" : "disposition-submission-qc",
      "display" : "Disposition submission Quality Check"
    },
    {
      "code" : "disposition-posting",
      "display" : "Disposition posting"
    },
    {
      "code" : "update-submission",
      "display" : "Update submission "
    },
    {
      "code" : "update-posting",
      "display" : "Update posting"
    }]
  },
  {
    "code" : "research-study-reason-stopped",
    "display" : "Research Study Reason Stopped",
    "concept" : [{
      "code" : "accrual-goal-met",
      "display" : "Accrual Goal Met",
      "definition" : "The study prematurely ended because the accrual goal was met."
    },
    {
      "code" : "closed-due-to-toxicity",
      "display" : "Closed due to toxicity",
      "definition" : "The study prematurely ended due to toxicity."
    },
    {
      "code" : "closed-due-to-lack-of-study-progress",
      "display" : "Closed due to lack of study progress",
      "definition" : "The study prematurely ended due to lack of study progress."
    },
    {
      "code" : "temporarily-closed-per-study-design",
      "display" : "Temporarily closed per study design",
      "definition" : "The study prematurely ended temporarily per study design."
    }]
  },
  {
    "code" : "research-study-objective-type",
    "display" : "Research Study Objective Type",
    "concept" : [{
      "code" : "primary",
      "display" : "Primary",
      "definition" : "The main question to be answered, and the one that drives any statistical planning for the study—e.g., calculation of the sample size to provide the appropriate power for statistical testing."
    },
    {
      "code" : "secondary",
      "display" : "Secondary",
      "definition" : "Question to be answered in the study that is of lesser importance than the primary objective."
    },
    {
      "code" : "exploratory",
      "display" : "Exploratory",
      "definition" : "Exploratory questions to be answered in the study."
    }]
  },
  {
    "code" : "research-study-arm-type",
    "display" : "Research Study Arm Type",
    "concept" : [{
      "code" : "active-comparator",
      "display" : "Active Comparator"
    },
    {
      "code" : "placebo-comparator",
      "display" : "Placebo Comparator"
    },
    {
      "code" : "sham-comparator",
      "display" : "Sham Comparator"
    },
    {
      "code" : "no-intervention",
      "display" : "No Intervention"
    },
    {
      "code" : "experimental",
      "display" : "Experimental"
    },
    {
      "code" : "other-arm-type",
      "display" : "Other Arm Type"
    }]
  }]
}

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.