@prefix dcterms: .
@prefix evs: .
@prefix m11: .
@prefix ncit: .
@prefix obo: .
@prefix owl: .
@prefix rdfs: .
@prefix skos: .
@prefix vann: .
@prefix xsd: .
m11: a owl:Ontology ;
rdfs:label "m11-rdf"@en ;
dcterms:creator "Kerstin Forsberg" ;
dcterms:description "A derived rendering of the ICH M11 Technical Specification (Step 4, 2025-11-19), the ICH M11 code lists and OID Listing, and the ICH M11 Terminology published by NCI EVS (release 2025-12-19): one IRI per protocol element, section and code list; the headings and fields of the ICH M11 Template (Step 4, 2025-11-19), each linked to its section and to the element it realises. Mapping statements from the elements to USDM v4 attributes (usdm-rdf), as stated in the HL7 FHIR Clinical Study Protocol IG ballot mapping (May 2026) and the CDISC DDF-RA v4.0.0 M11 mapping, are published separately as an SSSOM mapping set (rdfs:seeAlso) that points at these identifiers. Draft, not normative. Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH."@en ;
dcterms:license ;
dcterms:rights "Contains information derived from the ICH M11 Technical Specification, the ICH M11 Template and the ICH M11 code lists and OID Listing, copyright ICH, used under the ICH Legal Mentions (https://www.ich.org/page/legal-mentions); changes made: rendered as RDF and joined with the EVS terminology; of the Template, headings and fields rendered as RDF and linked to the elements, instructional and universal text not carried. Contains terms and definitions from the ICH M11 Terminology, NCI Enterprise Vocabulary Services, CC BY 4.0."@en ;
dcterms:source ,
,
,
;
dcterms:title "ICH M11 protocol elements and sections as linked data"@en ;
vann:preferredNamespacePrefix "m11" ;
vann:preferredNamespaceUri "https://w3id.org/m11-rdf/" ;
rdfs:seeAlso ,
m11:m11-usdm.sssom.tsv ;
owl:versionIRI m11:0.4.0 ;
owl:versionInfo "v0.4.0" .
m11:C217272.C218528 a m11:Section ;
skos:broader m11:C217272.C218527 ;
skos:definition "Section 3.1.1 of the ICH M11 Protocol standard, Primary Objective."@en ;
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skos:inScheme m11:C217272 ;
skos:prefLabel "3.1.1 Primary Objective"@en ;
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m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Primary Objective" ;
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m11:templateOrder 100 ;
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m11:fieldLabel "Enter Population" ;
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m11:templateConditional true ;
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m11:C217272.C218530 a m11:Section ;
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skos:definition "Section 3.2.1 of the ICH M11 Protocol standard, Secondary Objective."@en ;
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skos:prefLabel "3.2.1 Secondary Objective"@en ;
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skos:definition "Section 3.3.1 of the ICH M11 Protocol standard, Exploratory Objective."@en ;
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skos:definition "Section 10.4.1.1 of the ICH M11 Protocol standard, Statistical Analysis Method."@en ;
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skos:definition "Section 10.4.1.2 of the ICH M11 Protocol standard, Handling of Data in Relation to Primary Estimand(s)."@en ;
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skos:definition "Section 10.4.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis."@en ;
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skos:definition "Section 10.5.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis."@en ;
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skos:definition "A description of alternative techniques by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority."@en ;
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m11:C217353.C218478 a m11:Element ;
skos:definition "The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment."@en ;
skos:exactMatch evs:C217353.C218478 ;
skos:inScheme m11:C217353 ;
skos:prefLabel "Approximately <#/%> enrolled"@en ;
m11:concept ncit:C218478,
obo:NCIT_C218478 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional: if Original Protocol =No" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C222770 ;
m11:repeatReuse "Yes, reuse from the title page or other previous amendment" ;
m11:tocReference "Amendment Details" ;
m11:tsBlock 557 ;
m11:tsTerm "Approximately <#/%> enrolled" ] ;
m11:ichConceptCode "C218478" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.12"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217356.C132352 a m11:Element ;
skos:definition "The date that the sponsor approved a version of the protocol."@en ;
skos:exactMatch evs:C217356.C132352 ;
skos:inScheme m11:C217356 ;
skos:prefLabel "Approval Date"@en ;
m11:concept ncit:C132352,
obo:NCIT_C132352 ;
m11:hasSpecification _:spec51 ;
m11:ichConceptCode "C132352" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.16"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217357.C17649 a m11:Element ;
skos:inScheme m11:C217357 ;
skos:prefLabel "Other description"@en ;
m11:concept ncit:C17649,
obo:NCIT_C17649 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional if Other is selected as a Valid Value" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C222770 ;
m11:repeatReuse "No" ;
m11:tocReference "Amendment Details" ;
m11:tsBlock 67 ;
m11:tsTerm "" ],
[ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional if Other is selected as a Valid Value" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C222770 ;
m11:repeatReuse "No" ;
m11:tocReference "Amendment Details" ;
m11:tsBlock 71 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C17649" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
m11:labelSource m11:TechnicalSpecification ;
m11:pairBasis m11:StatedInTS .
m11:C217357.C218478 a m11:Element ;
skos:definition "The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment."@en ;
skos:exactMatch evs:C217357.C218478 ;
skos:inScheme m11:C217357 ;
skos:prefLabel "Approximately <#/%> enrolled"@en ;
m11:concept ncit:C218478,
obo:NCIT_C218478 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to Amendment Number" ;
m11:conformance "Conditional if Original Protocol =No" ;
m11:dataType "Number" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C222770 ;
m11:repeatReuse "Yes, reuse to section 12.3" ;
m11:tocReference "Amendment Details" ;
m11:tsBlock 61 ;
m11:tsTerm "Approximately <#/%> enrolled" ] ;
m11:ichConceptCode "C218478" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.15"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:cardinality a owl:DatatypeProperty ;
rdfs:label "cardinality"@en ;
rdfs:comment "The Cardinality field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:concept a owl:ObjectProperty ;
rdfs:label "concept"@en ;
rdfs:comment "The NCIt concept, always as the pair EVS identifier and OBO PURL (usdm-rdf decision D4). Not skos:exactMatch: one concept can be the concept of several elements."@en .
m11:conditionPath a owl:AnnotationProperty ;
rdfs:label "condition path"@en ;
rdfs:comment "The row's Condition Path cell, line breaks replaced by a space."@en .
m11:conformance a owl:DatatypeProperty ;
rdfs:label "conformance"@en ;
rdfs:comment "The Conformance field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:dataType a owl:DatatypeProperty ;
rdfs:label "data type"@en ;
rdfs:comment "The Data Type field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:dvh a owl:DatatypeProperty ;
rdfs:label "data, value or heading"@en ;
rdfs:comment "The Data (D), Value (V) or Heading (H) field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:fieldKind a owl:ObjectProperty ;
rdfs:label "field kind"@en ;
rdfs:domain m11:TemplateField ;
rdfs:range m11:TemplateFieldKind .
m11:fieldLabel a owl:DatatypeProperty ;
rdfs:label "field label"@en ;
rdfs:comment "The text inside the field's brackets as printed, line breaks and runs of white space as one space."@en ;
rdfs:domain m11:TemplateField .
m11:forSection a owl:ObjectProperty ;
rdfs:label "for section"@en ;
rdfs:comment "The top-level section a namespace belongs to, from the code list name (ICH M11 Section N Terminology)."@en ;
rdfs:domain m11:Namespace ;
rdfs:range m11:Section .
m11:hasConformanceCategory a owl:ObjectProperty ;
rdfs:label "has conformance category"@en ;
rdfs:domain m11:Specification ;
rdfs:range m11:ConformanceCategory .
m11:hasSpecification a owl:ObjectProperty ;
rdfs:label "has specification"@en ;
rdfs:domain m11:Element ;
rdfs:range m11:Specification .
m11:hasTemplateField a owl:ObjectProperty ;
rdfs:label "has Template field"@en ;
rdfs:comment "A field of the ICH M11 Template in this section. Fields under a repeating heading (12.X) are on the section they repeat under."@en ;
rdfs:domain m11:Section ;
rdfs:range m11:TemplateField .
m11:hasValueCodeList a owl:ObjectProperty ;
rdfs:label "has value code list"@en ;
rdfs:comment "The code list the Value field names, by its C-code."@en ;
rdfs:domain m11:Specification ;
rdfs:range m11:CodeList .
m11:headingElement a owl:ObjectProperty ;
rdfs:label "heading element"@en ;
rdfs:comment "The Template heading of this section is the Technical Specification term of this element (names normalised as in D2): the element is the text under the heading."@en ;
rdfs:domain m11:Section ;
rdfs:range m11:Element .
m11:ichConceptCode a owl:DatatypeProperty ;
rdfs:label "ICH concept code"@en ;
rdfs:domain m11:Element .
m11:ichNamespaceOid a owl:DatatypeProperty ;
rdfs:label "ICH namespace OID"@en ;
rdfs:comment "With m11:ichConceptCode, the pair by which ICH identifies the element. Taken from the OID Listing for the element's namespace."@en ;
rdfs:domain m11:Element ;
rdfs:range m11:ichOid .
m11:inSection a owl:ObjectProperty ;
rdfs:label "in section"@en ;
rdfs:comment "The section the ToC reference names, joined by section number to the C217272 term whose definition states that number. For a repeating section (3.1.X) the section it repeats under."@en ;
rdfs:domain m11:Specification ;
rdfs:range m11:Section .
m11:labelSource a owl:ObjectProperty ;
rdfs:label "label source"@en ;
rdfs:comment "EVS where EVS has the (namespace, concept) term; otherwise the Technical Specification term with its brackets removed."@en ;
rdfs:range m11:Basis .
m11:mappedTo a owl:AnnotationProperty ;
rdfs:label "mapped to"@en ;
rdfs:comment "A published mapping row states that values of this ICH M11 element are held at this USDM attribute (a usdm-rdf property), under the target path and condition the row gives. The link is the mapping publisher's; m11-rdf identifies the M11 side of the row. An annotation property, so that an element can point at an OWL property without punning."@en ;
rdfs:domain m11:Element .
m11:nameMatch a owl:DatatypeProperty ;
rdfs:label "name match"@en ;
rdfs:comment "exact (names equal after normalisation) or verb-dropped (equal after removing one leading verb: Enter, Select, Insert, Specify, Provide, Add, Describe, State, List)."@en .
m11:nameSource a owl:DatatypeProperty ;
rdfs:label "name source"@en ;
rdfs:comment "Which name of the element the field label was compared with: ts-term (the Technical Specification term), evs-label (the EVS preferred term), or ts-heading-context (the label matches several elements; the Technical Specification heading block before the element's block equals the first cell of the field's table row)."@en .
m11:objectResolution a owl:AnnotationProperty ;
rdfs:label "object resolution"@en ;
rdfs:comment "How the row's Class and Attribute resolved in usdm-rdf: by attribute name or by usdm:modelName (the relationship role name), and whether the attribute is inherited (the usdm-rdf property is declared on a superclass)."@en .
m11:pairBasis a owl:ObjectProperty ;
rdfs:label "pair basis"@en ;
rdfs:domain m11:Element ;
rdfs:range m11:Basis .
m11:placeScope a owl:DatatypeProperty ;
rdfs:label "place scope"@en ;
rdfs:comment "Where the element was looked for: section (an element block whose ToC reference is the field's or heading's section, X and # read as any number) or namespace (an element whose namespace is for the field's or heading's top-level section). On a section, the scope of its heading element."@en .
m11:realises a owl:ObjectProperty ;
rdfs:label "realises"@en ;
rdfs:comment "Content that realises an ICH M11 element. In this release only from a Template field to the element it is the field for (D5). Whether a USDM instance or a document section uses the same property is open (D4 skeleton)."@en ;
rdfs:range m11:Element .
m11:repeatPattern a owl:DatatypeProperty ;
rdfs:label "repeat pattern"@en ;
rdfs:comment "The ToC reference of a repeating section, verbatim (e.g. 3.2.X where X is a unique number for each Secondary Objective)."@en ;
rdfs:domain m11:Specification .
m11:repeatReuse a owl:DatatypeProperty ;
rdfs:label "repeating and reuse rules"@en ;
rdfs:comment "The Repeating and/or Reuse Rules field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:sectionNumber a owl:DatatypeProperty ;
rdfs:label "section number"@en ;
rdfs:comment "The section number stated in the C217272 term definition."@en ;
rdfs:domain m11:Section .
m11:sourceRow a owl:AnnotationProperty ;
rdfs:label "source row"@en ;
rdfs:comment "The spreadsheet row (1-based, as Excel numbers it) of the Mapping sheet the record comes from."@en .
m11:sourceSection a owl:AnnotationProperty ;
rdfs:label "source section"@en ;
rdfs:comment "The row's Section Number, or its Section Title when the number is empty, verbatim."@en .
m11:statedAttribute a owl:AnnotationProperty ;
rdfs:label "stated attribute"@en ;
rdfs:comment "The row's Attribute cell, verbatim."@en .
m11:statedClass a owl:AnnotationProperty ;
rdfs:label "stated class"@en ;
rdfs:comment "The row's Class cell, verbatim."@en .
m11:statedCodeListOid a owl:DatatypeProperty ;
rdfs:label "code list OID as stated"@en ;
rdfs:comment "The OID the Value field gives for the code list, verbatim. Where it differs from the OID Listing, both are kept; the reconciliation report lists the difference."@en ;
rdfs:domain m11:Specification ;
rdfs:range m11:ichOid .
m11:subjectIdentification a owl:AnnotationProperty ;
rdfs:label "subject identification"@en ;
rdfs:comment "How the M11 side of the row was identified: by-code (the row's NCIt Code is the concept of the element) or by-unique-name (the row's element name, normalised, equals the term of exactly one Technical Specification element block)."@en .
m11:targetPath a owl:AnnotationProperty ;
rdfs:label "target path"@en ;
rdfs:comment "The row's Target Path cell, line breaks replaced by a space."@en .
m11:templateConditional a owl:DatatypeProperty ;
rdfs:label "Template conditional"@en ;
rdfs:comment "True when the Template prints the field inside {braces}, or the heading title in braces, its convention for conditional text (section 0.3)."@en ;
rdfs:range xsd:boolean .
m11:templateHeading a owl:DatatypeProperty ;
rdfs:label "Template heading"@en ;
rdfs:comment "The title of the section's heading in the ICH M11 Template, as printed, without its number."@en ;
rdfs:domain m11:Section .
m11:templateOptional a owl:DatatypeProperty ;
rdfs:label "Template optional"@en ;
rdfs:comment "True when the Template prints the field (all its non-instructional characters) or the heading in blue, its convention for optional text (section 0.3)."@en ;
rdfs:range xsd:boolean .
m11:templateOrder a owl:DatatypeProperty ;
rdfs:label "Template order"@en ;
rdfs:comment "Position of the field in the pinned Template, in reading order. A sort key, not an identifier."@en ;
rdfs:domain m11:TemplateField .
m11:templatePage a owl:DatatypeProperty ;
rdfs:label "Template page"@en ;
rdfs:comment "The page of the Template PDF (1-based) where the field or heading is printed."@en .
m11:templateSectionNumber a owl:DatatypeProperty ;
rdfs:label "Template section number"@en ;
rdfs:comment "The number of the Template heading the field is under, as printed (12.X), or Title Page, Amendment Details."@en ;
rdfs:domain m11:TemplateField .
m11:tocReference a owl:DatatypeProperty ;
rdfs:label "ToC reference"@en ;
rdfs:comment "The Relationship content from ToC field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:tsBlock a owl:DatatypeProperty ;
rdfs:label "TS block"@en ;
rdfs:comment "Number of the component block in Technical Specification Appendix 1, in document order, as counted by scripts/parse_ts.py."@en ;
rdfs:domain m11:Specification .
m11:tsTerm a owl:DatatypeProperty ;
rdfs:label "TS term"@en ;
rdfs:comment "The Term (Variable) field, verbatim."@en ;
rdfs:domain m11:Specification .
m11:C217045 a m11:ValueCodeList ;
skos:definition "Terminology associated with the trial phase value set codelist of the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217045 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.19"^^m11:ichOid ;
skos:prefLabel "Trial Phase Response Terminology"@en ;
m11:concept ncit:C217045,
obo:NCIT_C217045 .
m11:C217047 a m11:ValueCodeList ;
skos:definition "Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217047 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.3"^^m11:ichOid ;
skos:prefLabel "Amendment Scope Response Terminology"@en ;
m11:concept ncit:C217047,
obo:NCIT_C217047 .
m11:C217049 a m11:ValueCodeList ;
skos:definition "Terminology associated with the site distribution value set codelist of the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217049 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.20"^^m11:ichOid ;
skos:prefLabel "Trial Site Distribution Response Terminology"@en ;
m11:concept ncit:C217049,
obo:NCIT_C217049 .
m11:C217050 a m11:ValueCodeList ;
skos:definition "Terminology associated with the site geographic scope value set codelist of the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217050 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.21"^^m11:ichOid ;
skos:prefLabel "Trial Site Geographic Scope Response Terminology"@en ;
m11:concept ncit:C217050,
obo:NCIT_C217050 .
m11:C217051 a m11:ValueCodeList ;
skos:definition "Terminology associated with the trial blind schema value set codelist of the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217051 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.17"^^m11:ichOid ;
skos:prefLabel "Trial Blinding Schema Response Terminology"@en ;
m11:concept ncit:C217051,
obo:NCIT_C217051 .
m11:C217052 a m11:ValueCodeList ;
skos:definition "Terminology associated with the sourcing value set codelist of the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217052 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.9"^^m11:ichOid ;
skos:prefLabel "Investigational Intervention Sourcing Response Terminology"@en ;
m11:concept ncit:C217052,
obo:NCIT_C217052 .
m11:C217272.C218516 a m11:Section ;
skos:broader m11:C217272.C218515 ;
skos:definition "Section 1.1.1 of the ICH M11 Protocol standard, Primary and Secondary Objectives and Estimands."@en ;
skos:exactMatch evs:C217272.C218516 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "1.1.1 Primary and Secondary Objectives and Estimands"@en ;
m11:concept ncit:C218516,
obo:NCIT_C218516 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Primary and Secondary Objectives and Estimands" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217342.C218839 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 53 ;
m11:templatePage 22 ;
m11:templateSectionNumber "1.1.1" ] ;
m11:headingElement m11:C217342.C218839 ;
m11:placeScope "section" ;
m11:sectionNumber "1.1.1" ;
m11:templateConditional false ;
m11:templateHeading "Primary and Secondary Objectives and Estimands" ;
m11:templateOptional false ;
m11:templatePage 22 .
m11:C217272.C218519 a m11:Section ;
skos:broader m11:C217272.C218514 ;
skos:definition "Section 1.3 of the ICH M11 Protocol standard, Schedule of Activities."@en ;
skos:exactMatch evs:C217272.C218519 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "1.3 Schedule of Activities"@en ;
m11:concept ncit:C218519,
obo:NCIT_C218519 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Schedule of Activities" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217342.C132349 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 93 ;
m11:templatePage 25 ;
m11:templateSectionNumber "1.3" ] ;
m11:headingElement m11:C217342.C132349 ;
m11:placeScope "section" ;
m11:sectionNumber "1.3" ;
m11:templateConditional false ;
m11:templateHeading "Schedule of Activities" ;
m11:templateOptional false ;
m11:templatePage 25 .
m11:C217272.C218521 a m11:Section ;
skos:broader m11:C217272.C218520 ;
skos:definition "Section 2.1 of the ICH M11 Protocol standard, Purpose of Trial."@en ;
skos:exactMatch evs:C217272.C218521 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "2.1 Purpose of Trial"@en ;
m11:concept ncit:C218521,
obo:NCIT_C218521 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Purpose of Trial" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217343.C146997 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 94 ;
m11:templatePage 26 ;
m11:templateSectionNumber "2.1" ] ;
m11:headingElement m11:C217343.C146997 ;
m11:placeScope "section" ;
m11:sectionNumber "2.1" ;
m11:templateConditional false ;
m11:templateHeading "Purpose of Trial" ;
m11:templateOptional false ;
m11:templatePage 26 .
m11:C217272.C218523 a m11:Section ;
skos:broader m11:C217272.C218522 ;
skos:definition "Section 2.2.2 of the ICH M11 Protocol standard, Risk Summary and Mitigation Strategy."@en ;
skos:exactMatch evs:C217272.C218523 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "2.2.1 Risk Summary and Mitigation Strategy"@en ;
m11:concept ncit:C218523,
obo:NCIT_C218523 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Benefit Summary" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217343.C218724 ;
m11:templateConditional false ;
m11:templateOptional true ;
m11:templateOrder 98 ;
m11:templatePage 27 ;
m11:templateSectionNumber "2.2.2" ] ;
m11:headingElement m11:C217343.C218724 ;
m11:placeScope "section" ;
m11:sectionNumber "2.2.2" ;
m11:templateConditional false ;
m11:templateHeading "Benefit Summary" ;
m11:templateOptional true ;
m11:templatePage 26 .
m11:C217272.C218525 a m11:Section ;
skos:broader m11:C217272.C218522 ;
skos:definition "Section 2.2.3 of the ICH M11 Protocol standard, Overall Risk-Benefit Assessment."@en ;
skos:exactMatch evs:C217272.C218525 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "2.2.3 Overall Risk-Benefit Assessment"@en ;
m11:concept ncit:C218525,
obo:NCIT_C218525 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Overall Risk-Benefit Assessment" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217343.C218725 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 99 ;
m11:templatePage 27 ;
m11:templateSectionNumber "2.2.3" ] ;
m11:headingElement m11:C217343.C218725 ;
m11:placeScope "section" ;
m11:sectionNumber "2.2.3" ;
m11:templateConditional false ;
m11:templateHeading "Overall Risk-Benefit Assessment" ;
m11:templateOptional true ;
m11:templatePage 27 .
m11:C217272.C218535 a m11:Section ;
skos:broader m11:C217272.C218534 ;
skos:definition "Section 4.1.1 of the ICH M11 Protocol standard, Stakeholder Input into Design."@en ;
skos:exactMatch evs:C217272.C218535 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "4.1.1 Stakeholder Input into Design"@en ;
m11:concept ncit:C218535,
obo:NCIT_C218535 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Stakeholder Input into Design" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217345.C218729 ;
m11:templateConditional false ;
m11:templateOptional true ;
m11:templateOrder 116 ;
m11:templatePage 31 ;
m11:templateSectionNumber "4.1.1" ] ;
m11:headingElement m11:C217345.C218729 ;
m11:placeScope "section" ;
m11:sectionNumber "4.1.1" ;
m11:templateConditional false ;
m11:templateHeading "Stakeholder Input into Design" ;
m11:templateOptional true ;
m11:templatePage 31 .
m11:C217272.C218537 a m11:Section ;
skos:broader m11:C217272.C218536 ;
skos:definition "Section 4.2.1 of the ICH M11 Protocol standard, Rationale for Estimand(s)."@en ;
skos:exactMatch evs:C217272.C218537 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "4.2.1 Rationale for Estimand(s)"@en ;
m11:concept ncit:C218537,
obo:NCIT_C218537 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Rationale for Estimand(s)" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217345.C218730 ;
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skos:definition "Section 11.10 of the ICH M11 Protocol standard, Protocol Deviations."@en ;
skos:exactMatch evs:C217272.C218663 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "11.10 Protocol Deviations"@en ;
m11:concept ncit:C218663,
obo:NCIT_C218663 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Protocol Deviations" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217352.C218827 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 258 ;
m11:templatePage 62 ;
m11:templateSectionNumber "11.10" ] ;
m11:headingElement m11:C217352.C218827 ;
m11:placeScope "section" ;
m11:sectionNumber "11.10" ;
m11:templateConditional false ;
m11:templateHeading "Protocol Deviations" ;
m11:templateOptional false ;
m11:templatePage 62 .
m11:C217272.C218665 a m11:Section ;
skos:broader m11:C217272.C218649 ;
skos:definition "Section 11.12 of the ICH M11 Protocol standard, Data Dissemination."@en ;
skos:exactMatch evs:C217272.C218665 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "11.12 Data Dissemination"@en ;
m11:concept ncit:C218665,
obo:NCIT_C218665 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Data Dissemination" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217352.C218831 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 262 ;
m11:templatePage 63 ;
m11:templateSectionNumber "11.12" ] ;
m11:headingElement m11:C217352.C218831 ;
m11:placeScope "section" ;
m11:sectionNumber "11.12" ;
m11:templateConditional false ;
m11:templateHeading "Data Dissemination" ;
m11:templateOptional false ;
m11:templatePage 62 .
m11:C217272.C218667 a m11:Section ;
skos:broader m11:C217272.C218666 ;
skos:definition "Section 12.1 of the ICH M11 Protocol standard, Clinical Laboratory Tests."@en ;
skos:exactMatch evs:C217272.C218667 ;
skos:inScheme m11:C217272 ;
skos:prefLabel "12.1 Clinical Laboratory Tests"@en ;
m11:concept ncit:C218667,
obo:NCIT_C218667 ;
m11:hasTemplateField [ a m11:TemplateField ;
m11:fieldKind m11:TextInsertion ;
m11:fieldLabel "Enter Clinical Laboratory Tests" ;
m11:nameMatch "verb-dropped" ;
m11:nameSource "ts-term" ;
m11:placeScope "section" ;
m11:realises m11:C217353.C25294 ;
m11:templateConditional false ;
m11:templateOptional false ;
m11:templateOrder 263 ;
m11:templatePage 64 ;
m11:templateSectionNumber "12.1" ] ;
m11:headingElement m11:C217353.C25294 ;
m11:placeScope "section" ;
m11:sectionNumber "12.1" ;
m11:templateConditional false ;
m11:templateHeading "Clinical Laboratory Tests" ;
m11:templateOptional false ;
m11:templatePage 64 .
m11:C217277 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the intervention model responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217277 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.6"^^m11:ichOid ;
skos:prefLabel "Intervention Model Response Terminology"@en ;
m11:concept ncit:C217277,
obo:NCIT_C217277 .
m11:C217278 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the population type responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217278 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.12"^^m11:ichOid ;
skos:prefLabel "Population Type Response Terminology"@en ;
m11:concept ncit:C217278,
obo:NCIT_C217278 .
m11:C217279 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the control type responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217279 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.4"^^m11:ichOid ;
skos:prefLabel "Control Type Response Terminology"@en ;
m11:concept ncit:C217279,
obo:NCIT_C217279 .
m11:C217280 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the trial intervention assignment method responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217280 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.18"^^m11:ichOid ;
skos:prefLabel "Trial Intervention Assignment Method Response Terminology"@en ;
m11:concept ncit:C217280,
obo:NCIT_C217280 .
m11:C217281 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the trial blinding role responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217281 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.16"^^m11:ichOid ;
skos:prefLabel "Trial Blinding Role Response Terminology"@en ;
m11:concept ncit:C217281,
obo:NCIT_C217281 .
m11:C217282 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the independent committee name responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217282 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.5"^^m11:ichOid ;
skos:prefLabel "Independent Committee Name Response Terminology"@en ;
m11:concept ncit:C217282,
obo:NCIT_C217282 .
m11:C217283 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the trial arm type responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217283 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.15"^^m11:ichOid ;
skos:prefLabel "Trial Arm Type Response Terminology"@en ;
m11:concept ncit:C217283,
obo:NCIT_C217283 .
m11:C217284 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the intervention type responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217284 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.7"^^m11:ichOid ;
skos:prefLabel "Intervention Type Response Terminology"@en ;
m11:concept ncit:C217284,
obo:NCIT_C217284 .
m11:C217285 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the intervention use responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217285 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.8"^^m11:ichOid ;
skos:prefLabel "Intervention Use Response Terminology"@en ;
m11:concept ncit:C217285,
obo:NCIT_C217285 .
m11:C217286 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the investigational medicinal product indicator responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217286 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.10"^^m11:ichOid ;
skos:prefLabel "Investigational Medicinal Product Indicator Response Terminology"@en ;
m11:concept ncit:C217286,
obo:NCIT_C217286 .
m11:C217287 a m11:ValueCodeList ;
skos:definition "A valid value set relevant to the trial-related safety event type responses within the ICH M11 protocol template."@en ;
skos:exactMatch evs:C217287 ;
skos:notation "2.16.840.1.113883.3.989.2.3.1.22"^^m11:ichOid ;
skos:prefLabel "Trial-Related Safety Event Type Response Terminology"@en ;
m11:concept ncit:C217287,
obo:NCIT_C217287 .
m11:C217342.C112038 a m11:Element ;
skos:definition "A description of the condition, disease or disorder that the clinical trial is intended to investigate or address."@en ;
skos:exactMatch evs:C217342.C112038 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Population Diagnosis or Condition"@en ;
m11:concept ncit:C112038,
obo:NCIT_C112038 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Heading; One to Sponsor Protocol Identifier" ;
m11:conformance "Required" ;
m11:dataType "Valid Value or Text" ;
m11:dvh "V or D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "Yes, repeatable for each population diagnosis or condition" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 105 ;
m11:tsTerm "[Population Diagnosis or Condition]" ] ;
m11:ichConceptCode "C112038" ;
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m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C142585 a m11:Element ;
skos:definition "A unique name that is globally recognised and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients."@en ;
skos:exactMatch evs:C217342.C142585 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "INN"@en ;
m11:concept ncit:C142585,
obo:NCIT_C142585 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to many" ;
m11:conformance "Conditional: if there is an INN" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "Yes, repeatable for each INN used as control" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 109 ;
m11:tsTerm "or [INN] or" ] ;
m11:ichConceptCode "C142585" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218475 a m11:Element ;
skos:definition "The technique used to assign trial participants to a trial intervention or trial arm."@en ;
skos:exactMatch evs:C217342.C218475 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Intervention Assignment Method"@en ;
m11:concept ncit:C218475,
obo:NCIT_C218475 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217280 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.18"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 119 ;
m11:tsTerm "[Intervention Assignment Method]" ] ;
m11:ichConceptCode "C218475" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218675 a m11:Element ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Sponsor’s Investigational Product Code(s)"@en ;
m11:concept ncit:C218675,
obo:NCIT_C218675 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Heading; One to Protocol Identifier" ;
m11:conformance "Required Either Sponsor Investigational Product Code or Nonproprietary Name" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "Yes, repeatable from Title Page Sponsor Investigational Product Code(s) yes, reuse for each Investigational Product" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 96 ;
m11:tsTerm "[Sponsor’s Investigational Product Code(s)]" ] ;
m11:ichConceptCode "C218675" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:TechnicalSpecification ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218703 a m11:Element ;
skos:definition "A characterisation or classification of the trial population."@en ;
skos:exactMatch evs:C217342.C218703 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Population Type"@en ;
m11:concept ncit:C218703,
obo:NCIT_C218703 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Heading; One to Sponsor Protocol Identifier" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217278 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.12"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 101 ;
m11:tsTerm "[Population Type]" ] ;
m11:ichConceptCode "C218703" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218704 a m11:Element ;
skos:definition "An indication as to whether the occurrence applies to a single or multiple trial sites."@en ;
skos:exactMatch evs:C217342.C218704 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Site Distribution"@en ;
m11:concept ncit:C218704,
obo:NCIT_C218704 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217049 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.20"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 125 ;
m11:tsTerm "[Site Distribution]" ] ;
m11:ichConceptCode "C218704" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218705 a m11:Element ;
skos:definition "An indication as to whether the trial is taking place in one or more countries."@en ;
skos:exactMatch evs:C217342.C218705 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Site Geographic Scope"@en ;
m11:concept ncit:C218705,
obo:NCIT_C218705 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217050 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.21"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 126 ;
m11:tsTerm "[Site Geographic Scope]" ] ;
m11:ichConceptCode "C218705" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218706 a m11:Element ;
skos:definition "An indication as to whether the clinical trial uses an adaptive trial design."@en ;
skos:exactMatch evs:C217342.C218706 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Adaptive Trial Design Indicator"@en ;
m11:concept ncit:C218706,
obo:NCIT_C218706 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217046 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 132 ;
m11:tsTerm "[Adaptive Trial Design Indicator]" ] ;
m11:ichConceptCode "C218706" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218707 a m11:Element ;
skos:definition "An indication as to whether the protocol is a master protocol."@en ;
skos:exactMatch evs:C217342.C218707 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Master Protocol Indicator"@en ;
m11:concept ncit:C218707,
obo:NCIT_C218707 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217046 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 128 ;
m11:tsTerm "[Master Protocol Indicator]" ] ;
m11:ichConceptCode "C218707" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218708 a m11:Element ;
skos:definition "An indication as to whether the clinical trial is testing a drug-device combination product."@en ;
skos:exactMatch evs:C217342.C218708 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Drug/Device Combination Product Indicator"@en ;
m11:concept ncit:C218708,
obo:NCIT_C218708 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217046 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 130 ;
m11:tsTerm "[Drug/Device Combination Product Indicator]" ] ;
m11:ichConceptCode "C218708" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218709 a m11:Element ;
skos:definition "An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function."@en ;
skos:exactMatch evs:C217342.C218709 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Blinded Roles"@en ;
m11:concept ncit:C218709,
obo:NCIT_C218709 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to many" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217281 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.16"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 138 ;
m11:tsTerm "[Blinded Roles]" ] ;
m11:ichConceptCode "C218709" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218710 a m11:Element ;
skos:definition "A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum."@en ;
skos:exactMatch evs:C217342.C218710 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Target/Maximum"@en ;
m11:concept ncit:C218710,
obo:NCIT_C218710 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 140 ;
m11:tsTerm "[Target/Maximum]" ] ;
m11:ichConceptCode "C218710" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218711 a m11:Element ;
skos:definition "The target or maximum number of participants who have been randomly assigned to the trial intervention or enrolled in the trial."@en ;
skos:exactMatch evs:C217342.C218711 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "randomly assigned to trial intervention/enrolled"@en ;
m11:concept ncit:C218711,
obo:NCIT_C218711 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 142 ;
m11:tsTerm "[randomly assigned to trial intervention/enrolled]" ] ;
m11:ichConceptCode "C218711" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218712 a m11:Element ;
skos:definition "The numeric value for the planned duration of trial intervention."@en ;
skos:exactMatch evs:C217342.C218712 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "total planned duration of trial intervention"@en ;
m11:concept ncit:C218712,
obo:NCIT_C218712 ;
m11:hasSpecification _:spec145 ;
m11:ichConceptCode "C218712" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218713 a m11:Element ;
skos:definition "The unit of time associated with the numeric value for the planned duration of trial intervention."@en ;
skos:exactMatch evs:C217342.C218713 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "total planned duration of trial intervention unit of time"@en ;
m11:concept ncit:C218713,
obo:NCIT_C218713 ;
m11:hasSpecification _:spec145 ;
m11:ichConceptCode "C218713" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218714 a m11:Element ;
skos:definition "An alternative textual narrative for the planned duration of trial intervention."@en ;
skos:exactMatch evs:C217342.C218714 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Alternate Description of Planned Duration of Trial Intervention"@en ;
m11:concept ncit:C218714,
obo:NCIT_C218714 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: when an alternate description for planned duration of trial Intervention if the duration varies" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 146 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C218714" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218715 a m11:Element ;
skos:definition "The numeric value for the planned duration of trial participation."@en ;
skos:exactMatch evs:C217342.C218715 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "total planned duration of trial participation"@en ;
m11:concept ncit:C218715,
obo:NCIT_C218715 ;
m11:hasSpecification _:spec148 ;
m11:ichConceptCode "C218715" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218716 a m11:Element ;
skos:definition "The unit of time associated with the numeric value for the planned duration of trial participation."@en ;
skos:exactMatch evs:C217342.C218716 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "total planned duration of trial participation unit of time"@en ;
m11:concept ncit:C218716,
obo:NCIT_C218716 ;
m11:hasSpecification _:spec148 ;
m11:ichConceptCode "C218716" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218717 a m11:Element ;
skos:definition "An alternative narrative for the planned duration of trial participation."@en ;
skos:exactMatch evs:C217342.C218717 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Alternate Description of Planned Duration of Trial Participation"@en ;
m11:concept ncit:C218717,
obo:NCIT_C218717 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: when an alternate description for planned duration of trial participation if duration will vary" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 149 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C218717" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218718 a m11:Element ;
skos:definition "An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities."@en ;
skos:exactMatch evs:C217342.C218718 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Independent Committees"@en ;
m11:concept ncit:C218718,
obo:NCIT_C218718 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to many" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217282 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.5"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 153 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218718" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218719 a m11:Element ;
skos:definition "A committee that is different than the one(s) previously specified or mentioned."@en ;
skos:exactMatch evs:C217342.C218719 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Other Committees"@en ;
m11:concept ncit:C218719,
obo:NCIT_C218719 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 155 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218719" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218720 a m11:Element ;
skos:definition "A brief written record describing the trial schematic."@en ;
skos:exactMatch evs:C217342.C218720 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Schema Notes"@en ;
m11:concept ncit:C218720,
obo:NCIT_C218720 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218518 ;
m11:repeatReuse "Yes, repeatable and aligned with appropriate schema" ;
m11:tocReference "1.2" ;
m11:tsBlock 158 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218720" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C218838 a m11:Element ;
skos:definition "A narrative providing additional details about the duration of a participant's use of a trial intervention or their planned participation time in the trial."@en ;
skos:exactMatch evs:C217342.C218838 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Additional Description of Duration"@en ;
m11:concept ncit:C218838,
obo:NCIT_C218838 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 150 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218838" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C223136 a m11:Element ;
skos:definition "An indication as to whether stratification is used as part of the randomisation process."@en ;
skos:exactMatch evs:C217342.C223136 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Stratification Indicator"@en ;
m11:concept ncit:C223136,
obo:NCIT_C223136 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Sponsor Protocol Identifier" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217046 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.11"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 123 ;
m11:tsTerm "[Stratification Indicator]" ] ;
m11:ichConceptCode "C223136" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C223137 a m11:Element ;
skos:definition "A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups."@en ;
skos:exactMatch evs:C217342.C223137 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Randomisation Type"@en ;
m11:concept ncit:C223137,
obo:NCIT_C223137 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Sponsor Protocol Identifier; One to Randomisation" ;
m11:conformance "Conditional if Randomisation is selected as Valid Value" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 120 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C223137" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C223138 a m11:Element ;
skos:definition "Description of any intervention assignment method that is different than the one(s) previously specified or mentioned."@en ;
skos:exactMatch evs:C217342.C223138 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Other Intervention Assignment Method"@en ;
m11:concept ncit:C223138,
obo:NCIT_C223138 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Sponsor Protocol Identifier; One to Other" ;
m11:conformance "Conditional if Other is selected as a Valid Value" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C222770 ;
m11:repeatReuse "No" ;
m11:tocReference "Amendment Details" ;
m11:tsBlock 121 ;
m11:tsTerm "{" ] ;
m11:ichConceptCode "C49692" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C49693 a m11:Element ;
skos:definition "The anticipated minimum age of the participants to be entered in a clinical trial."@en ;
skos:exactMatch evs:C217342.C49693 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Minimum Age"@en ;
m11:concept ncit:C49693,
obo:NCIT_C49693 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Number" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 113 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C49693" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C49694 a m11:Element ;
skos:definition "The anticipated maximum age of the participants to be entered in a clinical trial."@en ;
skos:exactMatch evs:C217342.C49694 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Maximum Age"@en ;
m11:concept ncit:C49694,
obo:NCIT_C49694 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Number" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 116 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C49694" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C98746 a m11:Element ;
skos:definition "The overall design configuration for assigning intervention to participants."@en ;
skos:exactMatch evs:C217342.C98746 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Intervention Model"@en ;
m11:concept ncit:C98746,
obo:NCIT_C98746 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one; One to Heading; One to Sponsor Protocol Identifier" ;
m11:conformance "Required" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Required ;
m11:hasValueCodeList m11:C217277 ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.6"^^m11:ichOid ;
m11:tocReference "1.1.2" ;
m11:tsBlock 99 ;
m11:tsTerm "[Intervention Model]" ] ;
m11:ichConceptCode "C98746" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217342.C98771 a m11:Element ;
skos:definition "The planned number of intervention groups."@en ;
skos:exactMatch evs:C217342.C98771 ;
skos:inScheme m11:C217342 ;
skos:prefLabel "Number of Arms"@en ;
m11:concept ncit:C98771,
obo:NCIT_C98771 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Number" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218517 ;
m11:repeatReuse "No" ;
m11:tocReference "1.1.2" ;
m11:tsBlock 134 ;
m11:tsTerm "[Number of Arms]" ] ;
m11:ichConceptCode "C98771" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.1"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217343.C218721 a m11:Element ;
skos:definition "A description of the potential risks associated with the trial interventions and mitigation strategies to be employed within the trial."@en ;
skos:exactMatch evs:C217343.C218721 ;
skos:inScheme m11:C217343 ;
skos:prefLabel "Trial-specific Intervention Risks and Mitigations"@en ;
m11:concept ncit:C218721,
obo:NCIT_C218721 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218524 ;
m11:repeatReuse "No" ;
m11:tocReference "2.2.1" ;
m11:tsBlock 166 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218721" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217343.C218722 a m11:Element ;
skos:definition "A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial."@en ;
skos:exactMatch evs:C217343.C218722 ;
skos:inScheme m11:C217343 ;
skos:prefLabel "Trial-specific Procedure Risks and Mitigations"@en ;
m11:concept ncit:C218722,
obo:NCIT_C218722 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218524 ;
m11:repeatReuse "No" ;
m11:tocReference "2.2.1" ;
m11:tsBlock 167 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218722" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217343.C218723 a m11:Element ;
skos:definition "A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial that are different than the one(s) previously specified or mentioned."@en ;
skos:exactMatch evs:C217343.C218723 ;
skos:inScheme m11:C217343 ;
skos:prefLabel "Trial-specific Other Risks and Mitigations"@en ;
m11:concept ncit:C218723,
obo:NCIT_C218723 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218524 ;
m11:repeatReuse "No" ;
m11:tocReference "2.2.1" ;
m11:tsBlock 168 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218723" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.2"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217344.C188853 a m11:Element ;
skos:definition "Population level summary for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions."@en ;
skos:exactMatch evs:C217344.C188853 ;
skos:inScheme m11:C217344 ;
skos:prefLabel "Population-level Summary"@en ;
m11:concept ncit:C188853,
obo:NCIT_C188853 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Primary Objective Table; Project Identifier" ;
m11:conformance "Conditional: If there is a population-level summary as estimand" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218527 ;
m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Primary Objective" ;
m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
m11:tsBlock 186 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Secondary Objective Table; Project Identifier" ;
m11:conformance "Conditional: If there is a population for Secondary" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218529 ;
m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Secondary Objective." ;
m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
m11:tsBlock 204 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Exploratory Objective Table, Project Identifier" ;
m11:conformance "Conditional: If there is a population-level summary" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218531 ;
m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:tsBlock 222 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C188853" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217344.C188856 a m11:Element ;
skos:definition "A description of the intercurrent event."@en ;
skos:exactMatch evs:C217344.C188856 ;
skos:inScheme m11:C217344 ;
skos:prefLabel "Description of Intercurrent Event"@en ;
m11:concept ncit:C188856,
obo:NCIT_C188856 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: If there is one or more other intercurrent events as estimand characteristic." ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218527 ;
m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
m11:repeatReuse "Yes, repeatable for each intercurrent event" ;
m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
m11:tsBlock 189 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to one or as many intercurrent event as available" ;
m11:conformance "Conditional: If there is one or more other intercurrent events." ;
m11:dataType "Text" ;
m11:dvh "H" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218529 ;
m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
m11:repeatReuse "Yes, repeatable for each intercurrent event" ;
m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
m11:tsBlock 207 ;
m11:tsTerm "{Description of Intercurrent Event}" ],
[ a m11:Specification ;
m11:cardinality "One to one or as many intercurrent event as available" ;
m11:conformance "Conditional: If there is one or more other intercurrent events as estimand characteristic." ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218531 ;
m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:repeatReuse "Yes, repeatable for each intercurrent event" ;
m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:tsBlock 225 ;
m11:tsTerm "{Description of Intercurrent Event}" ] ;
m11:ichConceptCode "C188856" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217344.C188857 a m11:Element ;
skos:definition "A description of the planned strategy to address intercurrent events."@en ;
skos:exactMatch evs:C217344.C188857 ;
skos:inScheme m11:C217344 ;
skos:prefLabel "Intercurrent Event Strategy"@en ;
m11:concept ncit:C188857,
obo:NCIT_C188857 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: If there is one or more other intercurrent events as estimand characteristic." ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218527 ;
m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
m11:repeatReuse "Yes, repeatable for each intercurrent event relationship" ;
m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
m11:tsBlock 190 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: If there is one or more other intercurrent events." ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218529 ;
m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
m11:repeatReuse "Yes, repeatable for each intercurrent event relationship" ;
m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
m11:tsBlock 208 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: If there is one or more other intercurrent events as estimand characteristic." ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218531 ;
m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:repeatReuse "Yes, repeatable for each intercurrent event relationship" ;
m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:tsBlock 226 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C188857" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217344.C25212 a m11:Element ;
skos:definition "The variable to be obtained for each patient that is required to address the clinical question. The specification of the variable might include whether the patient experiences an intercurrent event."@en ;
skos:exactMatch evs:C217344.C25212 ;
skos:inScheme m11:C217344 ;
skos:prefLabel "Endpoint"@en ;
m11:concept ncit:C25212,
obo:NCIT_C25212 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Primary Objective Table; Project Identifier" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218527 ;
m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Primary Objective" ;
m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
m11:tsBlock 184 ;
m11:tsTerm "{< Endpoint >}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading, One to Secondary Objective Table, Project Identifier" ;
m11:conformance "Conditional: if there is a Secondary Objective" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218529 ;
m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Secondary Objective." ;
m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
m11:tsBlock 202 ;
m11:tsTerm "{< Endpoint >}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Exploratory Objective Table, Project Identifier" ;
m11:conformance "Conditional: if there is exploratory endpoint(s)." ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218531 ;
m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:tsBlock 220 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C25212" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217344.C49236 a m11:Element ;
skos:definition "The treatment condition of interest and, as appropriate, the alternative treatment condition to which comparison will be made (referred to as \"treatment\" through the remainder of this document). These might be individual interventions, combinations of interventions administered concurrently, e.g. as add-on to standard of care, or might consist of an overall regimen involving a complex sequence of interventions."@en ;
skos:exactMatch evs:C217344.C49236 ;
skos:inScheme m11:C217344 ;
skos:prefLabel "Treatment"@en ;
m11:concept ncit:C49236,
obo:NCIT_C49236 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Primary Objective Table; Project Identifier" ;
m11:conformance "Conditional: If there is a treatment as estimand characteristic" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218527 ;
m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Primary Objective" ;
m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
m11:tsBlock 182 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading, One to Secondary Objective Table, Project Identifier" ;
m11:conformance "Conditional: If there is a population for Secondary" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218529 ;
m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Secondary Objective." ;
m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
m11:tsBlock 200 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Exploratory Objective Table; Project Identifier" ;
m11:conformance "Conditional: If there is a treatment as estimand" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218531 ;
m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:tsBlock 218 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C49236" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217344.C70833 a m11:Element ;
skos:definition "The population of patients targeted by the clinical question. This will be represented by the entire trial population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event."@en ;
skos:exactMatch evs:C217344.C70833 ;
skos:inScheme m11:C217344 ;
skos:prefLabel "Population"@en ;
m11:concept ncit:C70833,
obo:NCIT_C70833 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Primary Objective Table; Primary Objective <#>; Protocol Identifier" ;
m11:conformance "Conditional: If there is a population as estimand characteristic" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218527 ;
m11:repeatPattern "3.1.X where X is a unique number for each Primary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Primary Objective" ;
m11:tocReference "3.1.X where X is a unique number for each Primary Objective" ;
m11:tsBlock 180 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Secondary Objective Table; Secondary Objective <#>; Protocol Identifier" ;
m11:conformance "Conditional: If there is a population for Secondary" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218529 ;
m11:repeatPattern "3.2.X where X is a unique number for each Secondary Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Secondary Objective." ;
m11:tocReference "3.2.X where X is a unique number for each Secondary Objective" ;
m11:tsBlock 198 ;
m11:tsTerm "{}" ],
[ a m11:Specification ;
m11:cardinality "One to Row Heading; One to Exploratory Objective Table, Exploratory Objective <#>, Protocol Identifier" ;
m11:conformance "Conditional: If there is a population as estimand characteristic" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218531 ;
m11:repeatPattern "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:repeatReuse "Yes, repeatable for each numbered Exploratory Objective." ;
m11:tocReference "3.3.X where X is a unique number for each Exploratory Objective" ;
m11:tsBlock 216 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C70833" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.3"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C142705 a m11:Element ;
skos:definition "An explanation as to the scientific reasons for the choice of the trial design."@en ;
skos:exactMatch evs:C217345.C142705 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Overall Rationale for Trial Design"@en ;
m11:concept ncit:C142705,
obo:NCIT_C142705 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Conditional: If Level 3 subheadings are not used" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Conditional ;
m11:inSection m11:C217272.C218536 ;
m11:repeatReuse "No" ;
m11:tocReference "4.2" ;
m11:tsBlock 237 ;
m11:tsTerm "{}" ] ;
m11:ichConceptCode "C142705" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C147139 a m11:Element ;
skos:definition "A description summarizing the overall trial design and intervention model."@en ;
skos:exactMatch evs:C217345.C147139 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Overall Description of Trial Design and Description of Intervention Model"@en ;
m11:concept ncit:C147139,
obo:NCIT_C147139 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218534 ;
m11:repeatReuse "No" ;
m11:tocReference "4.1" ;
m11:tsBlock 229 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C147139" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C218726 a m11:Element ;
skos:definition "A description of the trial duration."@en ;
skos:exactMatch evs:C217345.C218726 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Description of Trial Duration"@en ;
m11:concept ncit:C218726,
obo:NCIT_C218726 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218534 ;
m11:repeatReuse "No" ;
m11:tocReference "4.1" ;
m11:tsBlock 230 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218726" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C218727 a m11:Element ;
skos:definition "A description of the level of awareness of the study participants and/or personnel to the respective intervention(s) or assessments being observed, received or administered, and the methodology by which study participants or personnel are blinded."@en ;
skos:exactMatch evs:C217345.C218727 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Description of Level and Method of Blinding"@en ;
m11:concept ncit:C218727,
obo:NCIT_C218727 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218534 ;
m11:repeatReuse "No" ;
m11:tocReference "4.1" ;
m11:tsBlock 232 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218727" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C218728 a m11:Element ;
skos:definition "An extra or further textual description of the trial design."@en ;
skos:exactMatch evs:C217345.C218728 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Additional Description of Trial Design"@en ;
m11:concept ncit:C218728,
obo:NCIT_C218728 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218534 ;
m11:repeatReuse "No" ;
m11:tocReference "4.1" ;
m11:tsBlock 233 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218728" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C218736 a m11:Element ;
skos:definition "A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial start."@en ;
skos:exactMatch evs:C217345.C218736 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Start of Trial"@en ;
m11:concept ncit:C218736,
obo:NCIT_C218736 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218545 ;
m11:repeatReuse "No" ;
m11:tocReference "4.4" ;
m11:tsBlock 255 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218736" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C218737 a m11:Element ;
skos:definition "A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial end."@en ;
skos:exactMatch evs:C217345.C218737 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "End of Trial"@en ;
m11:concept ncit:C218737,
obo:NCIT_C218737 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218545 ;
m11:repeatReuse "No" ;
m11:tocReference "4.4" ;
m11:tsBlock 256 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218737" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217345.C219658 a m11:Element ;
skos:definition "A description of the methodology used to assign trial participants to a trial intervention or trial arm."@en ;
skos:exactMatch evs:C217345.C219658 ;
skos:inScheme m11:C217345 ;
skos:prefLabel "Description of Method of Assignment to Trial Intervention"@en ;
m11:concept ncit:C219658,
obo:NCIT_C219658 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Optional" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218534 ;
m11:repeatReuse "No" ;
m11:tocReference "4.1" ;
m11:tsBlock 231 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C219658" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.4"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217346.C179373 a m11:Element ;
skos:definition "The process of active consideration of participants for enrollment in a trial, for those potential participants who have failed a prior screening attempt."@en ;
skos:exactMatch evs:C217346.C179373 ;
skos:inScheme m11:C217346 ;
skos:prefLabel "Rescreening"@en ;
m11:concept ncit:C179373,
obo:NCIT_C179373 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218559 ;
m11:repeatReuse "No" ;
m11:tocReference "5.6" ;
m11:tsBlock 288 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C179373" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217346.C25370 a m11:Element ;
skos:definition "List of characteristics in a protocol, any one of which excludes a potential participant from participation in a study. (CDISC glossary)"@en ;
skos:exactMatch evs:C217346.C25370 ;
skos:inScheme m11:C217346 ;
skos:prefLabel "Exclusion Criterion"@en ;
m11:concept ncit:C25370,
obo:NCIT_C25370 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218550 ;
m11:repeatReuse "Yes, repeatable for each Exclusion Criterion, if deleted do not replace, do not duplicate" ;
m11:tocReference "5.3" ;
m11:tsBlock 270 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C25370" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217346.C25532 a m11:Element ;
skos:definition "The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary)"@en ;
skos:exactMatch evs:C217346.C25532 ;
skos:inScheme m11:C217346 ;
skos:prefLabel "Inclusion Criterion"@en ;
m11:concept ncit:C25532,
obo:NCIT_C25532 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218549 ;
m11:repeatReuse "Yes, number consecutively, repeatable for each Inclusion Criterion. If deleted for an amendment, do not replace and do not duplicate" ;
m11:tocReference "5.2" ;
m11:tsBlock 266 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C25532" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217346.C49628 a m11:Element ;
skos:definition "The potential participant who does not meet eligibility (inclusion/exclusion) criteria during the screening period."@en ;
skos:exactMatch evs:C217346.C49628 ;
skos:inScheme m11:C217346 ;
skos:prefLabel "Screen Failure"@en ;
m11:concept ncit:C49628,
obo:NCIT_C49628 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218559 ;
m11:repeatReuse "No" ;
m11:tocReference "5.6" ;
m11:tsBlock 287 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C49628" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.5"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217347.C142517 a m11:Element ;
skos:definition "The strength of a drug product, which indicates the amount of each active ingredient in a given dosage form, measured in units of volume or concentration."@en ;
skos:exactMatch evs:C217347.C142517 ;
skos:inScheme m11:C217347 ;
skos:prefLabel "Dosage Strength(s)"@en ;
m11:concept ncit:C142517,
obo:NCIT_C142517 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to each Pharmaceutical Dose Form" ;
m11:conformance "Optional: if the table used" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218560 ;
m11:repeatReuse "Yes, repeatable for each Intervention Name and Pharmaceutical Dose Form per Arm Name and Arm Type" ;
m11:tocReference "6" ;
m11:tsBlock 308 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C142517" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217347.C15697 a m11:Element ;
skos:definition "A description of the schedule and periodicity of a treatment or vaccination regimen."@en ;
skos:exactMatch evs:C217347.C15697 ;
skos:inScheme m11:C217347 ;
skos:prefLabel "Regimen/Treatment Period/Vaccination Regimen"@en ;
m11:concept ncit:C15697,
obo:NCIT_C15697 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to each Intervention Name, Pharmaceutical Dose Form, Dosage Strength per Arm Name" ;
m11:conformance "Optional: if the table used" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218560 ;
m11:repeatReuse "Yes, repeatable for each arm name" ;
m11:tocReference "6" ;
m11:tsBlock 311 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C15697" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217347.C172457 a m11:Element ;
skos:definition "A characterisation or classification of the study arm."@en ;
skos:exactMatch evs:C217347.C172457 ;
skos:inScheme m11:C217347 ;
skos:prefLabel "Arm Type"@en ;
m11:concept ncit:C172457,
obo:NCIT_C172457 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to each Arm Name" ;
m11:conformance "Optional: if the table used" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Optional ;
m11:hasValueCodeList m11:C217283 ;
m11:inSection m11:C217272.C218560 ;
m11:repeatReuse "Yes, repeatable for each Arm Name" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.15"^^m11:ichOid ;
m11:tocReference "6" ;
m11:tsBlock 304 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C172457" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217347.C177930 a m11:Element ;
skos:definition "The literal identifier (i.e. distinctive designation) for the study intervention."@en ;
skos:exactMatch evs:C217347.C177930 ;
skos:inScheme m11:C217347 ;
skos:prefLabel "Intervention Name"@en ;
m11:concept ncit:C177930,
obo:NCIT_C177930 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to Arm Name and Arm Type" ;
m11:conformance "Optional: if the table used" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Optional ;
m11:inSection m11:C217272.C218560 ;
m11:repeatReuse "Yes, repeatable for each Arm Name and Arm Type" ;
m11:tocReference "6" ;
m11:tsBlock 305 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C177930" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217347.C218747 a m11:Element ;
skos:definition "A free text description of the trial intervention; alternatively can be used as a heading for a table containing information about the trial intervention."@en ;
skos:exactMatch evs:C217347.C218747 ;
skos:inScheme m11:C217347 ;
skos:prefLabel "description of the overview of trial interventions or a heading for the optional table"@en ;
m11:concept ncit:C218747,
obo:NCIT_C218747 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to one" ;
m11:conformance "Required" ;
m11:dataType "Text" ;
m11:dvh "D" ;
m11:hasConformanceCategory m11:Required ;
m11:inSection m11:C217272.C218560 ;
m11:repeatReuse "No" ;
m11:tocReference "6" ;
m11:tsBlock 290 ;
m11:tsTerm "" ] ;
m11:ichConceptCode "C218747" ;
m11:ichNamespaceOid "2.16.840.1.113883.3.989.2.3.3.6"^^m11:ichOid ;
m11:labelSource m11:EVSTerminology ;
m11:pairBasis m11:StatedInTS .
m11:C217347.C218748 a m11:Element ;
skos:definition "The reason or intention for the use of the trial intervention within the trial arm."@en ;
skos:exactMatch evs:C217347.C218748 ;
skos:inScheme m11:C217347 ;
skos:prefLabel "Use"@en ;
m11:concept ncit:C218748,
obo:NCIT_C218748 ;
m11:hasSpecification [ a m11:Specification ;
m11:cardinality "One to each Intervention Name" ;
m11:conformance "Optional: if the table used" ;
m11:dataType "Valid Value" ;
m11:dvh "V" ;
m11:hasConformanceCategory m11:Optional ;
m11:hasValueCodeList m11:C217285 ;
m11:inSection m11:C217272.C218560 ;
m11:repeatReuse "Yes, repeatable for each Intervention Name per Arm Name" ;
m11:statedCodeListOid "2.16.840.1.113883.3.989.2.3.1.8"^^m11:ichOid ;
m11:tocReference "6" ;
m11:tsBlock 312 ;
m11:tsTerm "