Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - 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-ballot3 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

: M11 Report Section 7 (Participant Discontinuation) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

Page standards status: Informative

Raw ttl | Download


@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 -------------------------------------------------------------------

 a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "568064"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "2" ] ;
fhir:lastUpdated [ fhir:v "2026-05-30T22:59:15.010Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-07"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-07>     ] )
  ] ; # 
  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 568064</b></p><a name=\"568064\"> </a><a name=\"hc568064\"> </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: 2; Last updated: 2026-05-30 22:59:15+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-section-07.html\">M11ReportSection07</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/568064\">https://fevir.net/resources/Composition/568064</a></p><p><b>identifier</b>: FEvIR Object Identifier/568064</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 C218583}\">section7-participant-discontinuation</span></p><p><b>date</b>: 2026-05-30 22:59:15+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 7 (Participant Discontinuation) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example</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-267245.html\">A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example</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 7 (Participant Discontinuation) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568064. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568064. Computable resource at: https://fevir.net/resources/Composition/568064#json.</p>\n</div></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status>     ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ;
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/568064"^^xsd:anyURI ;
fhir:l <https://fevir.net/resources/Composition/568064>
  ] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>         ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ]       ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ]     ] ;
fhir:system [
fhir:v "https://fevir.net/FOI"^^xsd:anyURI ;
fhir:l <https://fevir.net/FOI>     ] ;
fhir:value [ fhir:v "568064" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
a loinc:35528-9 ;
fhir:system [
fhir:v "http://loinc.org"^^xsd:anyURI ;
fhir:l <http://loinc.org>       ] ;
fhir:code [ fhir:v "35528-9" ] ;
fhir:display [ fhir:v "Clinical trial protocol Clinical trial protocol" ]     ] ) ;
fhir:text [ fhir:v "CeSHarP Report" ]
  ] ; # 
  fhir:category ( [
    ( 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 "C218583" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL" ]     ] ) ;
fhir:text [ fhir:v "section7-participant-discontinuation" ]
  ] ) ; # 
  fhir:subject ( [
fhir:l fhir:ResearchStudy/267245 ;
fhir:reference [ fhir:v "ResearchStudy/267245" ] ;
fhir:type [
fhir:v "ResearchStudy"^^xsd:anyURI ;
fhir:l fhir:ResearchStudy     ] ;
fhir:display [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example" ]
  ] ) ; # 
  fhir:date [ fhir:v "2026-05-30T22:59:15.010Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:display [ fhir:v "Brian S. Alper, MD, MSPH" ]
  ] ) ; # 
  fhir:title [ fhir:v "M11 Report Section 7 (Participant Discontinuation) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"] ; # 
  fhir:custodian [
fhir:l fhir:Organization/118079 ;
fhir:reference [ fhir:v "Organization/118079" ] ;
fhir:type [
fhir:v "Organization"^^xsd:anyURI ;
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 fhir:ResearchStudy/267245 ;
fhir:reference [ fhir:v "ResearchStudy/267245" ] ;
fhir:type [
fhir:v "ResearchStudy"^^xsd:anyURI ;
fhir:l fhir:ResearchStudy       ] ;
fhir:display [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example" ]     ]
  ] [
fhir:type [ fhir:v "cite-as" ] ;
fhir:target [
a fhir:Markdown ;
fhir:v "M11 Report Section 7 (Participant Discontinuation) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568064. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568064. Computable resource at: https://fevir.net/resources/Composition/568064#json."     ]
  ] ) ; # 
  fhir:section ( [
fhir:title [ fhir:v "Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial" ] ;
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 "C218583" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL" ]       ] ) ;
fhir:text [ fhir:v "section7-participant-discontinuation" ]     ] ;
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 ]     ] ;
    ( fhir:section [
fhir:title [ fhir:v "Discontinuation of Trial Intervention for Individual Participants" ] ;
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 "C218584" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants" ]         ] ) ;
fhir:text [ fhir:v "section7.1-discontinuation-of-trial-intervention" ]       ] ;
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 ]       ] ;
      ( fhir:section [
fhir:title [ fhir:v "Permanent Discontinuation of Trial Intervention" ] ;
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 "C218585" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention" ]           ] ) ;
fhir:text [ fhir:v "section7.1.1-permanent-discontinuation-of-trial-intervention" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>See Section 7.2</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Temporary Discontinuation of Trial Intervention" ] ;
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 "C218586" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention" ]           ] ) ;
fhir:text [ fhir:v "section7.1.2-temporary-discontinuation-of-trial-intervention" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not Applicable.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Rechallenge" ] ;
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 "C218587" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7.1.3 Rechallenge" ]           ] ) ;
fhir:text [ fhir:v "section7.1.3-rechallenge" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not Applicable.</p></div>"^^rdf:XMLLiteral ]         ]       ] )     ] [
fhir:title [ fhir:v "Participant Discontinuation or Withdrawal from the Trial" ] ;
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 "C218588" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial" ]         ] ) ;
fhir:text [ fhir:v "section7.2-participant-withdrawal" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Patients will be discontinued in the following circumstances: • enrollment in any other clinical study involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study • participation in the study needs to be stopped for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and good clinical practice • investigator decision o the investigator decides that the patient should be discontinued from the study for any reason. If this decision is made because of an AE, SAE, or a severe hypoglycemia event, appropriate measures are to be taken. Lilly or its designee is to be alerted. • patient decision o the patient, or legal representative, requests to be withdrawn from the study Patients discontinuing from the study prematurely for any reason must complete AE and follow-up procedures as shown in the Schedule of Activities (Section 1.3) 7.2.1 Discontinuation of the Study Following the review of the safety data from the first 6 patients to complete Period 2 Day 1, the study will be stopped if deemed necessary for patient safety in the opinion of the Investigator and sponsor (Section 10.3.7). The study will be discontinued if Lilly or its designee judges it necessary for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and GCP</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Management of Loss to Follow-Up" ] ;
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 "C218589" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up" ]         ] ) ;
fhir:text [ fhir:v "section7.3-lost-to-follow-up" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>A patient will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact patients who fail to return for a scheduled visit or were otherwise unable to be followed up by the site.</p></div>"^^rdf:XMLLiteral ]       ]     ] )
  ] ) . #