{
  "resourceType" : "CodeSystem",
  "id" : "research-study-document-types-code-system",
  "language" : "en",
  "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><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" : "trial-use"
  }],
  "url" : "http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.40.44.16.6"
  }],
  "version" : "1.0.0-ballot3",
  "name" : "ResearchStudyDocumentTypesCodeSystem",
  "title" : "Research Study Document Types Code System",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-03-27T09:54:14+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."
  }]
}