@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@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 -------------------------------------------------------------------

<http://hl7.org/fhir/uv/ebm/Composition/568050> a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "568050"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "1" ] ;
     fhir:lastUpdated [ fhir:v "2026-05-30T15:21:18.691Z"^^xsd:dateTime ] ;
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-08"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-08>
     ] )
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  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "extensions" ] ;
     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Composition 568050</b></p><a name=\"568050\"> </a><a name=\"hc568050\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2026-05-30 15:21:18+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-section-08.html\">M11ReportSection08</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/568050\">https://fevir.net/resources/Composition/568050</a></p><p><b>identifier</b>: FEvIR Object Identifier/568050</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 35528-9}\">CeSHarP Report</span></p><p><b>category</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218590}\">section8-assessments</span></p><p><b>date</b>: 2026-05-30 15:21:18+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template</p><p><b>custodian</b>: <a href=\"Organization-118079.html\">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href=\"ResearchStudy-568025.html\">M11ResearchStudy Template</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568050. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568050. Computable resource at: https://fevir.net/resources/Composition/568050#json.</p>\n</div></blockquote></div>"^^rdf:XMLLiteral ]
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  fhir:extension ( [
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       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status>
     ] ;
     fhir:value [
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           fhir:l <http://terminology.hl7.org/CodeSystem/cited-artifact-status-type>
         ] ;
         fhir:code [ fhir:v "active" ] ;
         fhir:display [ fhir:v "Active" ]
       ] )
     ]
  ] ) ; # 
  fhir:url [
     fhir:v "https://fevir.net/resources/Composition/568050"^^xsd:anyURI ;
     fhir:l <https://fevir.net/resources/Composition/568050>
  ] ; # 
  fhir:identifier ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [
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           fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>
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       ] ) ;
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     fhir:assigner [
       fhir:display [ fhir:v "Computable Publishing LLC" ]
     ]
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  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
     fhir:coding ( [
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         fhir:l <http://loinc.org>
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       fhir:code [ fhir:v "35528-9" ] ;
       fhir:display [ fhir:v "Clinical trial protocol Clinical trial protocol" ]
     ] ) ;
     fhir:text [ fhir:v "CeSHarP Report" ]
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  fhir:category ( [
     fhir:coding ( [
       fhir:system [
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       fhir:display [ fhir:v "ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES" ]
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     fhir:text [ fhir:v "section8-assessments" ]
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  fhir:subject ( [
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     ] ;
     fhir:display [ fhir:v "M11ResearchStudy Template" ]
  ] ) ; # 
  fhir:date [ fhir:v "2026-05-30T15:21:18.691Z"^^xsd:dateTime] ; # 
  fhir:author ( [
     fhir:display [ fhir:v "Brian S. Alper, MD, MSPH" ]
  ] ) ; # 
  fhir:title [ fhir:v "M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template"] ; # 
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       fhir:l fhir:Organization
     ] ;
     fhir:display [ fhir:v "Computable Publishing LLC" ]
  ] ; # 
  fhir:relatesTo ( [
     fhir:type [ fhir:v "derived-from" ] ;
     fhir:target [
       a fhir:Reference ;
       fhir:l <http://hl7.org/fhir/uv/ebm/ResearchStudy/568025> ;
       fhir:reference [ fhir:v "ResearchStudy/568025" ] ;
       fhir:type [
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         fhir:l fhir:ResearchStudy
       ] ;
       fhir:display [ fhir:v "M11ResearchStudy Template" ]
     ]
  ] [
     fhir:type [ fhir:v "cite-as" ] ;
     fhir:target [
       a fhir:Markdown ;
       fhir:v "M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568050. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568050. Computable resource at: https://fevir.net/resources/Composition/568050#json."
     ]
  ] ) ; # 
  fhir:section ( [
     fhir:title [ fhir:v "Trial Assessments and Procedures" ] ;
     fhir:code [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
           fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
         ] ;
         fhir:code [ fhir:v "C218590" ] ;
         fhir:display [ fhir:v "ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES" ]
       ] ) ;
       fhir:text [ fhir:v "section8-assessments" ]
     ] ;
     fhir:text [
       fhir:status [ fhir:v "empty" ] ;
       fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"^^rdf:XMLLiteral ]
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       fhir:code [
         fhir:coding ( [
           fhir:system [
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       fhir:text [
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         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe general considerations applicable across trial assessments and procedures.]</div>"^^rdf:XMLLiteral ]
       ]
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       fhir:code [
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           ] ;
           fhir:code [ fhir:v "C218592" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures" ]
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         fhir:text [ fhir:v "section8.2-screening-baseline-assessments" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe any assessments and procedures that are unique to screening/baseline (e.g., collection of data on participant characteristics, assessments/procedures performed for the purpose of determining eligibility or for stratification) in this section. Describe screening and baseline assessments and procedures separately when screening and baseline are different or performed at different visits.]</div>"^^rdf:XMLLiteral ]
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       fhir:code [
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             fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
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         fhir:text [ fhir:v "section8.3-efficacy-assessments" ]
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       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe efficacy assessments and procedures in this section. Cross reference Section 8.7 Immunogenicity Assessments if immunogenicity assessments are used in efficacy determination.]</div>"^^rdf:XMLLiteral ]
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     ] [
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       fhir:code [
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       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe safety assessments and procedures utilizing the following subsections as applicable. Add level 3 headings as needed. • Identify any noninvestigator party responsible for evaluation of laboratory or other safety assessments (e.g., Sponsor or external Independent Data Monitoring Committee; cross refer to Section 11.4 Committees for details as applicable). • Include guidelines for the medical management of relevant laboratory or other safety assessment abnormalities.]</div>"^^rdf:XMLLiteral ]
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         fhir:code [
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             fhir:code [ fhir:v "C218595" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 8.4.1 Physical Examination" ]
           ] ) ;
           fhir:text [ fhir:v "section8.4.1-physical-examination" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "empty" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection and interpretation of physical examinations.]</div>"^^rdf:XMLLiteral ]
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             fhir:code [ fhir:v "C218596" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 8.4.2 Vital Signs" ]
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         fhir:text [
           fhir:status [ fhir:v "empty" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection and interpretation of vital signs.]</div>"^^rdf:XMLLiteral ]
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         fhir:title [ fhir:v "Electrocardiograms" ] ;
         fhir:code [
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             fhir:code [ fhir:v "C218597" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 8.4.3 Electrocardiograms" ]
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         fhir:text [
           fhir:status [ fhir:v "empty" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection, interpretation, and archiving of ECGs.]</div>"^^rdf:XMLLiteral ]
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       ] [
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           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Describe any specific instructions for the collection and interpretation of clinical laboratory assessments, including: • type of laboratory (central/local/hybrid) • acceptability of additional tests deemed necessary by the investigator or local regulations • instructions for situations in which central laboratory results are not available in time for trial intervention and/or response evaluation, or in the event of a severe disruption (e.g., a pandemic or natural disaster) • treatment algorithms for results out of normal range • cross reference Section 12.1 Clinical Laboratory Tests for laboratory assessment panels]</div>"^^rdf:XMLLiteral ]
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       ] [
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             fhir:display [ fhir:v "ICH M11 Protocol Section 8.4.5 Pregnancy Testing" ]
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         fhir:text [
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         fhir:title [ fhir:v "Suicidal Ideation and Behaviour Risk Monitoring" ] ;
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             fhir:display [ fhir:v "ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring" ]
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         fhir:text [
           fhir:status [ fhir:v "empty" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If the trial meets any of the criteria requiring suicidal ideation and behaviour risk monitoring by the guidance/guideline in each region, include justification for the need for suicidal ideation and behaviour risk monitoring in the study and add any specific instructions for the collection and interpretation of the assessment. In case this is an AESI in the study, justification should also be provided in Section 9.2.4 Adverse Events of Special Interest.]</div>"^^rdf:XMLLiteral ]
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       ] )
     ] [
       fhir:title [ fhir:v "Pharmacokinetics" ] ;
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         fhir:coding ( [
           fhir:system [
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         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection and assay of samples and interpretation of PK assessments. • Describe the biological samples collected, the handling of samples, and the assay method. o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of analyses for each sample. • Define the PK parameters to be calculated and the calculation methods.]</div>"^^rdf:XMLLiteral ]
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           fhir:display [ fhir:v "ICH M11 Protocol Section 8.6 Biomarkers" ]
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         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only). Include any specific instructions for the collection of samples and assessment of biomarkers, including pharmacodynamics. If biomarker or pharmacodynamic testing is not included in the study, state “Not Applicable.” •	Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o	Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. •	Describe the retention time for the samples (ensuring alignment with the ICF). •	Indicate the types of biomarkers that will be studied for each sample. •	Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div>"^^rdf:XMLLiteral ]
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       fhir:section ( [
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             ] ;
             fhir:code [ fhir:v "C218603" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics" ]
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           fhir:text [ fhir:v "section8.6.1-genetics-pharmacogenomics" ]
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         fhir:text [
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           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection and assay of samples for genetic, genomic, pharmacogenetic and/or pharmacogenomic analysis. • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.), handling of samples, and the assay method. o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of analyses that may be studied for each sample.]</div>"^^rdf:XMLLiteral ]
         ]
       ] [
         fhir:title [ fhir:v "Pharmacodynamic Biomarkers" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
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             ] ;
             fhir:code [ fhir:v "C218604" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers" ]
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         fhir:text [
           fhir:status [ fhir:v "empty" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection of samples and assessment of pharmacodynamic biomarkers. • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div>"^^rdf:XMLLiteral ]
         ]
       ] [
         fhir:title [ fhir:v "Other Biomarkers" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218605" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 8.6.3 Other Biomarkers" ]
           ] ) ;
           fhir:text [ fhir:v "section8.6.3-other" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "empty" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection of samples and assessment of other biomarkers. • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div>"^^rdf:XMLLiteral ]
         ]
       ] )
     ] [
       fhir:title [ fhir:v "Immunogenicity Assessments" ] ;
       fhir:code [
         fhir:coding ( [
           fhir:system [
             fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
             fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
           ] ;
           fhir:code [ fhir:v "C218606" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 8.7 Immunogenicity Assessments" ]
         ] ) ;
         fhir:text [ fhir:v "section8.7-immunogenicity-assessments" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Include any specific instructions for the collection of samples and interpretation of immunogenicity. If immunogenicity assessments are included within Efficacy Assessments or Safety Assessments, cross-reference to that section. •	Describe the biological samples that will be collected (e.g., tissue, serum, plasma). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div>"^^rdf:XMLLiteral ]
       ]
     ] [
       fhir:title [ fhir:v "Medical Resource Utilisation and Health Economics" ] ;
       fhir:code [
         fhir:coding ( [
           fhir:system [
             fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
             fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
           ] ;
           fhir:code [ fhir:v "C218607" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics" ]
         ] ) ;
         fhir:text [ fhir:v "section8.8-economics" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[This section does not apply to COAs. Include this section only for any value evidence and outcomes assessments not included in either the efficacy or safety sections. Describe the health outcome measures, collection method (e.g., diary, physician interview), and participant burden.]</div>"^^rdf:XMLLiteral ]
       ]
     ] )
  ] ) . # 

<http://hl7.org/fhir/uv/ebm/ResearchStudy/568025> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Organization/118079> a fhir:Uv .

# -------------------------------------------------------------------------------------