StructureDefinition-m11-section-09

Sourcehl7.fhir.uv.ebm#current:null (v5.0.0)
resourceTypeStructureDefinition
idm11-section-09
canonicalhttps://hl7.org/fhir/uv/ebm/StructureDefinition/m11-section-09
version0.1.0
statusdraft
publisherHL7 International - Clinical Decision Support WG
nameM11Section09
date2023-08-31T13:08:31+00:00
descriptionProfile of Composition for Evidence Based Medicine IG. The M11Section09 Profile is used for summary of Section 9 Statistical Considerations for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.
jurisdictionsuv
fhirVersion5.0.0
kindresource
abstractfalse
sdTtypeComposition
derivationconstraint
basehttps://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-report
Usages(none)
Name Flags Card. Type Description & Constraints doco
. . Composition EvidenceReport
. . . Slices for category 1 .. Slice: Unordered, Open by pattern:text
. . . . category:section09 S 1..1
. . . . . text 1.. Required Pattern: Section 9 Statistical Considerations
. . . Slices for section 4 .. Slice: Unordered, Open by pattern:code
. . . . section:analysisSets S 1..1
. . . . . code
. . . . . . text Required Pattern: 9.1 Analysis Sets
. . . . . text 1..
. . . . section:analysisPrimaryObjective S 1..*
. . . . . code
. . . . . . text Required Pattern: 9.2 Analysis Supporting Primary Objective
. . . . . focus Reference (OutcomeDefinition)
. . . . . text 1..
. . . . . Slices for section 3 .. Slice: Unordered, Open by pattern:code
. . . . . . section:statisticalModel S 1..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.2.1 Statistical Model, Hypothesis, and Method of Analysis
. . . . . . . text 1..
. . . . . . . entry Reference (EndpointAnalysisPlan)
. . . . . . section:intercurrentEventHandling S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.2.2 Handling of Intercurrent Events of Primary Estimand
. . . . . . . text 1..
. . . . . . section:missingData S 1..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.2.3 Handling of Missing Data
. . . . . . . text 1..
. . . . . . section:sensitvityAnalysis S 1..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.2.4 Sensitivity Analysis
. . . . . . . text 1..
. . . . . . . entry Reference (EndpointAnalysisPlan)
. . . . . . section:supplementaryAnalysis S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.2.5 Supplementary Analysis
. . . . . . . text 1..
. . . . section:secondaryAnalysis S 0..*
. . . . . code
. . . . . . text Required Pattern: 9.3 Analysis Supporting Secondary Objective
. . . . . focus Reference (OutcomeDefinition)
. . . . . text 1..
. . . . . Slices for section Slice: Unordered, Open by pattern:code
. . . . . . section:statisticalModel S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.3.1 Statistical Model, Hypothesis, and Method of Analysis
. . . . . . . text 1..
. . . . . . . entry Reference (EndpointAnalysisPlan)
. . . . . . section:intercurrentEventHandling S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.3.2 Handling of Intercurrent Events of Secondary Estimand
. . . . . . . text 1..
. . . . . . section:missingData S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.3.3 Handling of Missing Data
. . . . . . . text 1..
. . . . . . section:sensitvityAnalysis S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.3.4 Sensitivity Analysis
. . . . . . . text 1..
. . . . . . . entry Reference (EndpointAnalysisPlan)
. . . . . . section:supplementaryAnalysis S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.3.5 Supplementary Analysis
. . . . . . . text 1..
. . . . section:exploratoryAnalysis S 0..*
. . . . . code
. . . . . . text Required Pattern: 9.4 Analysis of Exploratory Objective
. . . . . focus Reference (OutcomeDefinition)
. . . . . text 1..
. . . . . Slices for section Slice: Unordered, Open by pattern:code
. . . . . . section:statisticalModel S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.4.1 Statistical Model, Hypothesis, and Method of Analysis
. . . . . . . text 1..
. . . . . . . entry Reference (EndpointAnalysisPlan)
. . . . . . section:intercurrentEventHandling S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.4.2 Handling of Intercurrent Events of Exploratory Estimand
. . . . . . . text 1..
. . . . . . section:missingData S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.4.3 Handling of Missing Data
. . . . . . . text 1..
. . . . . . section:sensitvityAnalysis S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.4.4 Sensitivity Analysis
. . . . . . . text 1..
. . . . . . . entry Reference (EndpointAnalysisPlan)
. . . . . . section:supplementaryAnalysis S 0..1 BackboneElement
. . . . . . . code
. . . . . . . . text Required Pattern: 9.4.5 Supplementary Analysis
. . . . . . . text 1..
. . . . section:safetyAnalyses S 0..1
. . . . . code
. . . . . . text Required Pattern: 9.5 Safety Analyses
. . . . . text 1..
. . . . section:otherAnalyses S 0..1
. . . . . code
. . . . . . text Required Pattern: 9.6 Other Analyses
. . . . . text 1..
. . . . section:interimAnalyses S 0..1
. . . . . code
. . . . . . text Required Pattern: 9.7 Interim Analyses
. . . . . text 1..
. . . . section:sampleSize S 1..1
. . . . . code
. . . . . . text Required Pattern: 9.8 Sample Size Determination
. . . . . text 1..
. . . . section:protocolDeviations S 1..1
. . . . . code
. . . . . . text Required Pattern: 9.9 Protocol Deviations
. . . . . text 1..

doco Documentation for this format

Produced 08 Sep 2023