Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: Research Study Document Types Code System - TTL Representation

Page standards status: Trial-use Maturity Level: 1

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "research-study-document-types-code-system"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir: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>"^^rdf:XMLLiteral
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
fhir:value [
a fhir:integer ;
fhir:v 1     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "cds"     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "trial-use"     ]
  ] ) ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.44.16.5" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0.0-ballot2"] ; # 
  fhir:name [ fhir:v "ResearchStudyDocumentTypesCodeSystem"] ; # 
  fhir:title [ fhir:v "Research Study Document Types Code System"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2025-09-10T16:45:37+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Clinical Decision Support"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Clinical Decision Support" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/dss" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Codes for use in the DocumentReference.type element when referenced from ResearchStudy.relatesTo.targetReference."] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ]     ] )
  ] ) ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "19"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "adverse-event-monitoring-plan" ] ;
fhir:display [ fhir:v "Adverse event monitoring plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed." ]
  ] [
fhir:code [ fhir:v "ancillary-care-plan" ] ;
fhir:display [ fhir:v "Ancillary care plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for treatment and supportive care activities provided during and after the study." ]
  ] [
fhir:code [ fhir:v "auditing-plan" ] ;
fhir:display [ fhir:v "Auditing plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how research study integrity will be evaluated, monitored, and managed." ]
  ] [
fhir:code [ fhir:v "confidential-personal-data-management-plan" ] ;
fhir:display [ fhir:v "Confidential personal data management plan" ] ;
fhir:definition [ fhir:v "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." ]
  ] [
fhir:code [ fhir:v "consent-form" ] ;
fhir:display [ fhir:v "Consent form" ] ;
fhir:definition [ fhir:v "The document used to obtain and record consent or assent." ]
  ] [
fhir:code [ fhir:v "consent-plan" ] ;
fhir:display [ fhir:v "Consent plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how consent or assent will be obtained." ]
  ] [
fhir:code [ fhir:v "data-access-plan" ] ;
fhir:display [ fhir:v "Data access plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how all of some of the research study dataset will be made available." ]
  ] [
fhir:code [ fhir:v "data-management-plan" ] ;
fhir:display [ fhir:v "Data management plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how data from a study will be collected, preserved, and shared." ]
  ] [
fhir:code [ fhir:v "dataset" ] ;
fhir:display [ fhir:v "Dataset" ] ;
fhir:definition [ fhir:v "The collection of data generated by the research study." ]
  ] [
fhir:code [ fhir:v "dataset-access" ] ;
fhir:display [ fhir:v "Dataset access" ] ;
fhir:definition [ fhir:v "The information related to how to access the dataset." ]
  ] [
fhir:code [ fhir:v "declaration-of-interests" ] ;
fhir:display [ fhir:v "Declaration of interests" ] ;
fhir:definition [ fhir:v "The statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting." ]
  ] [
fhir:code [ fhir:v "dissemination-plan" ] ;
fhir:display [ fhir:v "Dissemination plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how research study results will be reported and advertised." ]
  ] [
fhir:code [ fhir:v "education" ] ;
fhir:display [ fhir:v "Education" ] ;
fhir:definition [ fhir:v "Instructional and orientational information." ]
  ] [
fhir:code [ fhir:v "interim-analysis-plan" ] ;
fhir:display [ fhir:v "Interim analysis plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection." ]
  ] [
fhir:code [ fhir:v "irb-approval" ] ;
fhir:display [ fhir:v "Institutional Review Board (IRB) approval" ] ;
fhir:definition [ fhir:v "The document that proposed or establishes Institutional Review Board (IRB) approval." ]
  ] [
fhir:code [ fhir:v "software" ] ;
fhir:display [ fhir:v "Software" ] ;
fhir:definition [ fhir:v "The executable tools used to support the conduct and reporting of the research study." ]
  ] [
fhir:code [ fhir:v "software-access" ] ;
fhir:display [ fhir:v "Software access" ] ;
fhir:definition [ fhir:v "The information related to how to access the research software." ]
  ] [
fhir:code [ fhir:v "specimen-plan" ] ;
fhir:display [ fhir:v "Specimen plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for how specimens collected during the study will be managed." ]
  ] [
fhir:code [ fhir:v "statistical-analysis-plan" ] ;
fhir:display [ fhir:v "Statistical analysis plan" ] ;
fhir:definition [ fhir:v "The detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study." ]
  ] ) . #