Resource CodeSystem/FHIR Server from package hl7.fhir.uv.ebm#current (47 ms)

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ValueSet
research-study-document-types	Research Study Document Types Value Set

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Narrative

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Source

{
  "resourceType" : "CodeSystem",
  "id" : "research-study-document-types-code-system",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem research-study-document-types-code-system</b></p><a name=\"research-study-document-types-code-system\"> </a><a name=\"hcresearch-study-document-types-code-system\"> </a><a name=\"research-study-document-types-code-system-en-US\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">adverse-event-monitoring-plan<a name=\"research-study-document-types-code-system-adverse-event-monitoring-plan\"> </a></td><td>Adverse event monitoring plan</td><td>The detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed.</td></tr><tr><td style=\"white-space:nowrap\">ancillary-care-plan<a name=\"research-study-document-types-code-system-ancillary-care-plan\"> </a></td><td>Ancillary care plan</td><td>The detailed protocol for treatment and supportive care activities provided during and after the study.</td></tr><tr><td style=\"white-space:nowrap\">auditing-plan<a name=\"research-study-document-types-code-system-auditing-plan\"> </a></td><td>Auditing plan</td><td>The detailed protocol for how research study integrity will be evaluated, monitored, and managed.</td></tr><tr><td style=\"white-space:nowrap\">confidential-personal-data-management-plan<a name=\"research-study-document-types-code-system-confidential-personal-data-management-plan\"> </a></td><td>Confidential personal data management plan</td><td>The detailed protocol for how personally identifiable data from a research study will be shared and preserved, and how such data will be protected from inappropriate sharing.</td></tr><tr><td style=\"white-space:nowrap\">consent-form<a name=\"research-study-document-types-code-system-consent-form\"> </a></td><td>Consent form</td><td>The document used to obtain and record consent or assent.</td></tr><tr><td style=\"white-space:nowrap\">consent-plan<a name=\"research-study-document-types-code-system-consent-plan\"> </a></td><td>Consent plan</td><td>The detailed protocol for how consent or assent will be obtained.</td></tr><tr><td style=\"white-space:nowrap\">data-access-plan<a name=\"research-study-document-types-code-system-data-access-plan\"> </a></td><td>Data access plan</td><td>The detailed protocol for how all of some of the research study dataset will be made available.</td></tr><tr><td style=\"white-space:nowrap\">data-management-plan<a name=\"research-study-document-types-code-system-data-management-plan\"> </a></td><td>Data management plan</td><td>The detailed protocol for how data from a study will be collected, preserved, and shared.</td></tr><tr><td style=\"white-space:nowrap\">dataset<a name=\"research-study-document-types-code-system-dataset\"> </a></td><td>Dataset</td><td>The collection of data generated by the research study.</td></tr><tr><td style=\"white-space:nowrap\">dataset-access<a name=\"research-study-document-types-code-system-dataset-access\"> </a></td><td>Dataset access</td><td>The information related to how to access the dataset.</td></tr><tr><td style=\"white-space:nowrap\">declaration-of-interests<a name=\"research-study-document-types-code-system-declaration-of-interests\"> </a></td><td>Declaration of interests</td><td>The statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting.</td></tr><tr><td style=\"white-space:nowrap\">dissemination-plan<a name=\"research-study-document-types-code-system-dissemination-plan\"> </a></td><td>Dissemination plan</td><td>The detailed protocol for how research study results will be reported and advertised.</td></tr><tr><td style=\"white-space:nowrap\">education<a name=\"research-study-document-types-code-system-education\"> </a></td><td>Education</td><td>Instructional and orientational information.</td></tr><tr><td style=\"white-space:nowrap\">interim-analysis-plan<a name=\"research-study-document-types-code-system-interim-analysis-plan\"> </a></td><td>Interim analysis plan</td><td>The detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection.</td></tr><tr><td style=\"white-space:nowrap\">irb-approval<a name=\"research-study-document-types-code-system-irb-approval\"> </a></td><td>Institutional Review Board (IRB) approval</td><td>The document that proposed or establishes Institutional Review Board (IRB) approval.</td></tr><tr><td style=\"white-space:nowrap\">software<a name=\"research-study-document-types-code-system-software\"> </a></td><td>Software</td><td>The executable tools used to support the conduct and reporting of the research study.</td></tr><tr><td style=\"white-space:nowrap\">software-access<a name=\"research-study-document-types-code-system-software-access\"> </a></td><td>Software access</td><td>The information related to how to access the research software.</td></tr><tr><td style=\"white-space:nowrap\">specimen-plan<a name=\"research-study-document-types-code-system-specimen-plan\"> </a></td><td>Specimen plan</td><td>The detailed protocol for how specimens collected during the study will be managed.</td></tr><tr><td style=\"white-space:nowrap\">statistical-analysis-plan<a name=\"research-study-document-types-code-system-statistical-analysis-plan\"> </a></td><td>Statistical analysis plan</td><td>The detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study.</td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 1
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "cds"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "draft"
    }
  ],
  "url" : "http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.44.16.3"
    }
  ],
  "version" : "1.0.0-ballot2",
  "name" : "ResearchStudyDocumentTypesCodeSystem",
  "title" : "Research Study Document Types Code System",
  "status" : "draft",
  "experimental" : false,
  "date" : "2025-05-15T13:52:28+00:00",
  "publisher" : "HL7 International / Clinical Decision Support",
  "contact" : [
    {
      "name" : "HL7 International / Clinical Decision Support",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/dss"
        }
      ]
    }
  ],
  "description" : "Codes for use in the DocumentReference.type element when referenced from ResearchStudy.relatesTo.targetReference.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 19,
  "concept" : [
    {
      "code" : "adverse-event-monitoring-plan",
      "display" : "Adverse event monitoring plan",
      "definition" : "The detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed."
    },
    {
      "code" : "ancillary-care-plan",
      "display" : "Ancillary care plan",
      "definition" : "The detailed protocol for treatment and supportive care activities provided during and after the study."
    },
    {
      "code" : "auditing-plan",
      "display" : "Auditing plan",
      "definition" : "The detailed protocol for how research study integrity will be evaluated, monitored, and managed."
    },
    {
      "code" : "confidential-personal-data-management-plan",
      "display" : "Confidential personal data management plan",
      "definition" : "The detailed protocol for how personally identifiable data from a research study will be shared and preserved, and how such data will be protected from inappropriate sharing."
    },
    {
      "code" : "consent-form",
      "display" : "Consent form",
      "definition" : "The document used to obtain and record consent or assent."
    },
    {
      "code" : "consent-plan",
      "display" : "Consent plan",
      "definition" : "The detailed protocol for how consent or assent will be obtained."
    },
    {
      "code" : "data-access-plan",
      "display" : "Data access plan",
      "definition" : "The detailed protocol for how all of some of the research study dataset will be made available."
    },
    {
      "code" : "data-management-plan",
      "display" : "Data management plan",
      "definition" : "The detailed protocol for how data from a study will be collected, preserved, and shared."
    },
    {
      "code" : "dataset",
      "display" : "Dataset",
      "definition" : "The collection of data generated by the research study."
    },
    {
      "code" : "dataset-access",
      "display" : "Dataset access",
      "definition" : "The information related to how to access the dataset."
    },
    {
      "code" : "declaration-of-interests",
      "display" : "Declaration of interests",
      "definition" : "The statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting."
    },
    {
      "code" : "dissemination-plan",
      "display" : "Dissemination plan",
      "definition" : "The detailed protocol for how research study results will be reported and advertised."
    },
    {
      "code" : "education",
      "display" : "Education",
      "definition" : "Instructional and orientational information."
    },
    {
      "code" : "interim-analysis-plan",
      "display" : "Interim analysis plan",
      "definition" : "The detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection."
    },
    {
      "code" : "irb-approval",
      "display" : "Institutional Review Board (IRB) approval",
      "definition" : "The document that proposed or establishes Institutional Review Board (IRB) approval."
    },
    {
      "code" : "software",
      "display" : "Software",
      "definition" : "The executable tools used to support the conduct and reporting of the research study."
    },
    {
      "code" : "software-access",
      "display" : "Software access",
      "definition" : "The information related to how to access the research software."
    },
    {
      "code" : "specimen-plan",
      "display" : "Specimen plan",
      "definition" : "The detailed protocol for how specimens collected during the study will be managed."
    },
    {
      "code" : "statistical-analysis-plan",
      "display" : "Statistical analysis plan",
      "definition" : "The detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study."
    }
  ]
}

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