Generated Narrative: StructureDefinition m11-protocol-summary

Name	Flags	Card.	Type	Description & Constraints
Extension		0..*	Extension	Summary of a protocol
extension		36..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:objectiveAndEstimandSummary	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"objectiveAndEstimandSummary"
value[x]		0..1		C218839 Primary and Secondary Objectives and Estimands
valueMarkdown			markdown
valueString			string
extension:interventionModel	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"interventionModel"
value[x]		0..1	CodeableConcept	C217277 Intervention Model Binding: ICH M11 Intervention Model Value Set Terminology (required)
extension:populationType	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"populationType"
value[x]		0..1	CodeableConcept	C217278 Population Type Binding: ICH M11 ... (required)
extension:controlType	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"controlType"
value[x]		0..1	CodeableConcept	C217279 Control Type Binding: ICH M11 ... (required)
extension:populationDiagnosisOrCondition	S	1..*	Extension	Extension
url		1..1	uri	"populationDiagnosisOrCondition"
extension:comparator		1..*	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"comparator"
value[x]		0..1	Reference(MedicinalProductDefinition)	Comparator
extension:minimumAge	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"minimumAge"
value[x]		0..1	Quantity	C49693/C25301 Minimum Age value/units
extension:unitsOfMinimumAge	S	1..1	Extension	Extension
url		1..1	uri	"unitsOfMinimumAge"
extension:maximumAge	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"maximumAge"
value[x]		0..1	Quantity	C49694/C25301 Minimum Age value/units
extension:unitsOfMaximumAge	S	1..1	Extension	Extension
url		1..1	uri	"unitsOfMaximumAge"
extension:interventionAssignmentMethod	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"interventionAssignmentMethod"
value[x]		0..1	CodeableConcept	C217280 Intervention Assignment Method Binding: ICH M11 ... (required)
extension:randomisationType	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"randomisationType"
value[x]		0..1		C223137 Randomisation Type
valueString			string
valueCodeableConcept			CodeableConcept
extension:otherInterventionAssignmentMethod	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"otherInterventionAssignmentMethod"
value[x]		0..1	string	C223138 Other Intervention Assignment Method}
extension:stratificationIndicator	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"stratificationIndicator"
value[x]		0..1	CodeableConcept	C223136 Stratification Indicator Binding: ICH M11 No Yes Value Set Terminology (required)
extension:siteDistribution	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"siteDistribution"
value[x]		0..1	CodeableConcept	C217049 Site Distribution Binding: ICH M11 ... (required)
extension:siteGeographicScope	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"siteGeographicScope"
value[x]		0..1	CodeableConcept	C217050: Site geographic scope Binding: ICH M11 ... (required)
extension:masterProtocolIndicator	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"masterProtocolIndicator"
value[x]		0..1	CodeableConcept	C217046 Master Protocol Indicator Binding: ICH M11 No Yes Value Set Terminology (required)
extension:drug-DeviceCombinationProductIndicator	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"drug-DeviceCombinationProductIndicator"
value[x]		0..1	CodeableConcept	C217046 Drug-Device Combination Product Indicator Binding: ICH M11 No Yes Value Set Terminology (required)
extension:adaptiveTrialDesignIndicator	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"adaptiveTrialDesignIndicator"
value[x]		0..1	CodeableConcept	C217046 Adaptive Trial Design Indicator Binding: ICH M11 No Yes Value Set Terminology (required)
extension:numberOfArms	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"numberOfArms"
value[x]		0..1	integer	C98771 Number of Arms
extension:trialBlindSchema	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"trialBlindSchema"
value[x]		0..1	CodeableConcept	C217051 Trial Blind Schema Binding: ICH M11 ... (required)
extension:blindedRoles	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"blindedRoles"
value[x]		0..1	CodeableConcept	C217281: Blinded Roles Binding: ICH M11 ... (required)
extension:targetOrMaximum	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"targetOrMaximum"
value[x]		0..1	CodeableConcept	Target-Maximum Binding: UDP ... (required)
extension:numberOfParticipants	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"numberOfParticipants"
value[x]		0..1	integer	C49692 Number of Participants
extension:totalPlannedDurationOfTrialIntervention		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"totalPlannedDurationOfTrialIntervention"
value[x]		0..1	time	C218712/C218713 total planned duration of trial intervention value/units
extension:totalPlannedDurationOfTrialInterventionUnitOfTime		1..1	Extension	Extension
url		1..1	uri	"totalPlannedDurationOfTrialInterventionUnitOfTime"
extension:alternateDescriptionOfPlannedDurationOfTrialIntervention		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"alternateDescriptionOfPlannedDurationOfTrialIntervention"
value[x]		0..1	string	C218714 alternate description of planned duration of trial intervention if duration will vary
extension:totalPlannedDurationOfTrialParticipation		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"totalPlannedDurationOfTrialParticipation"
value[x]		0..1	time	C218715/C218716 total planned duration of trial participation value/units
extension:totalPlannedDurationOfTrialParticipationUnitOfTime		1..1	Extension	Extension
url		1..1	uri	"totalPlannedDurationOfTrialParticipationUnitOfTime"
extension:alternateDescriptionOfPlannedDurationOfTrialParticipation		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"alternateDescriptionOfPlannedDurationOfTrialParticipation"
value[x]		0..1	string	C218717 alternate description of planned duration of trial participation if duration will vary
extension:additionalDescriptionofDuration		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"additionalDescriptionofDuration"
value[x]		0..1	string	C218838 Additional Description of Duration
extension:independentCommittees	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"independentCommittees"
value[x]		0..1	CodeableConcept	C217282 Independent Committees Binding: ICH M11 ... (required)
extension:otherCommittees		1..*	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"otherCommittees"
value[x]		0..1	string	C218719 Other Committees
extension:trialSchema	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"trialSchema"
value[x]		0..1	string	C93682 Trial Schema
extension:schemaNotes		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"schemaNotes"
value[x]		0..1	string	C218720 Schema Notes
extension:scheduleofActivities	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"scheduleofActivities"
value[x]		0..1	string	C132349 Schedule of Activities
url		1..1	uri	"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"
value[x]		0..0		Value of extension
Documentation for this format