M11 Report Section 11 (Trial Oversight) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example - TTL Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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 11 (Trial Oversight) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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@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#> .

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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Ethical Review The investigator must give assurance that the ethical review board (ERB) was properly constituted and convened as required by International Council for Harmonization (ICH) guidelines and other applicable laws and regulations. Documentation of ERB approval of the protocol and the ICF must be provided to Lilly before the study may begin at the investigative site(s). Lilly or its representatives must approve the ICF before it is used at the investigative site(s). All ICFs must be compliant with the ICH guideline on good clinical practice (GCP). The study site’s ERB(s) should be provided with the following: • the current Investigator’s Brochure or Package Insert and updates during the course of the study • ICF • relevant curricula vitae Protocol Signatures After reading the protocol, each principal investigator will sign the protocol signature page and send a copy of the signed page to a Lilly representative Final Report Signature The final report coordinating investigator or designee will sign the clinical study report for this study, indicating agreement that, to the best of his or her knowledge, the report accurately describes the conduct and results of the study. The investigator with the most enrolled patients will serve as the final report coordinating investigator. If this investigator is unable to fulfill this function, another investigator will be chosen by Lilly to serve as the final report coordinating investigator. The sponsor’s responsible medical officer and statistician will sign/approve the final clinical study report for this study, confirming that, to the best of his or her knowledge, the report accurately describes the conduct and results of the study.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Recruitment Lilly or its designee is responsible for the central recruitment strategy for patients. Individual investigators may have additional local requirements or processes. Study-specific recruitment material should be approved by Lilly. Protocol Signatures The sponsor’s responsible medical officer will approve the protocol, confirming that, to the best of his or her knowledge, the protocol accurately describes the planned design and conduct of the study. Final Report Signature The sponsor’s responsible medical officer and statistician will sign/approve the final clinical study report for this study, confirming that, to the best of his or her knowledge, the report accurately describes the conduct and results of the study.</p></div>"^^rdf:XMLLiteral ]         ]       ] )     ] [
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fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Data Quality Assurance To ensure accurate, complete, and reliable data, Lilly or its representatives will do the following: • provide instructional material to the study sites, as appropriate. • provide training to instruct the investigators and study coordinators. This training will give instruction on the protocol, the completion of the case report forms (CRFs), and study procedures. • make periodic visits to the study site. • be available for consultation and stay in contact with the study site personnel by mail, telephone, and/or fax. • review and evaluate CRF data and/or use standard computer edits to detect errors in data collection. • conduct a quality review of the database. In addition, Lilly or its representatives will periodically check a sample of the patient data recorded against source documents at the study site. The study may be audited by Lilly and/or regulatory agencies at any time. Investigators will be given notice before an audit occurs. The investigator will keep records of all original source data. This might include laboratory tests, medical records, and clinical notes. If requested, the investigator will provide the sponsor, applicable regulatory agencies, and applicable ERBs with direct access to the original source documents. Data Collection Tools/Source Data An electronic data capture system will be used in this study. The site must define and retain all source records and must maintain a record of any data where source data are directly entered into the data capture system. Data Protection Data systems used for the study will have controls and requirements in accordance with local data protection law. The purpose and use of patient personal information collected will be provided in a written document to the patient by the sponsor.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Protocol Deviations" ] ;
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 "C218663" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 11.10 Protocol Deviations" ]         ] ) ;
fhir:text [ fhir:v "section11.10-protocol-deviations" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Separate document.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "Early Site Closure" ] ;
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 "C218664" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 11.11 Early Site Closure" ]         ] ) ;
fhir:text [ fhir:v "section11.11-early-site-closure" ]       ] ;
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 "Decision Rights for Site Closure" ] ;
fhir:code [
fhir:text [ fhir:v "section11.11-early-site-closure#decisionRights" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Study site participation may be discontinued if Lilly or its designee, the investigator, or the ERB of the study site 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 "Crteria for Early Closure" ] ;
fhir:code [
fhir:text [ fhir:v "section11.11-early-site-closure#criteria" ]         ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[List the criteria for early closure of a site by the sponsor or investigator.]</div>"^^rdf:XMLLiteral ]         ]       ] [
fhir:title [ fhir:v "Responsibilities Following Early Site Closure" ] ;
fhir:code [
fhir:text [ fhir:v "section11.11-early-site-closure#responsibilities" ]         ] ;
fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[List the responsibilities of the sponsor and investigator following early site closure, such as informing the ethics committee(s), and prompt notification of the participant and their transition to appropriate therapy and/or follow-up.]</div>"^^rdf:XMLLiteral ]         ]       ] )     ] [
fhir:title [ fhir:v "Data Dissemination" ] ;
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 "C218665" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 11.12 Data Dissemination" ]         ] ) ;
fhir:text [ fhir:v "section11.12-data-dissemination" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Captured in separate documents</p></div>"^^rdf:XMLLiteral ]       ]     ] )
  ] ) . #