Generated Narrative: StructureDefinition m11-protocol-summary Name Flags Card. Type Description & Constraints Extension 0..* Extension Summary of a protocol #xD; extension 36..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:objectiveAndEstimandSummary S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "objectiveAndEstimandSummary" #xD; value[x] 0..1 C218839 Primary and Secondary Objectives and Estimands #xD; valueMarkdown markdown #xD; valueString string #xD; extension:interventionModel S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "interventionModel" #xD; value[x] 0..1 CodeableConcept C217277 Intervention Model Binding: ICH M11 Intervention Model Value Set Terminology (required) #xD; extension:populationType S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "populationType" #xD; value[x] 0..1 CodeableConcept C217278 Population Type Binding: ICH M11 ... (required) #xD; extension:controlType S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "controlType" #xD; value[x] 0..1 CodeableConcept C217279 Control Type Binding: ICH M11 ... (required) #xD; extension:populationDiagnosisOrCondition S 1..* Extension Extension #xD; url 1..1 uri "populationDiagnosisOrCondition" #xD; extension:comparator 1..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "comparator" #xD; value[x] 0..1 Reference(MedicinalProductDefinition) Comparator #xD; extension:minimumAge S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "minimumAge" #xD; value[x] 0..1 Quantity C49693/C25301 Minimum Age value/units #xD; extension:unitsOfMinimumAge S 1..1 Extension Extension #xD; url 1..1 uri "unitsOfMinimumAge" #xD; extension:maximumAge S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "maximumAge" #xD; value[x] 0..1 Quantity C49694/C25301 Minimum Age value/units #xD; extension:unitsOfMaximumAge S 1..1 Extension Extension #xD; url 1..1 uri "unitsOfMaximumAge" #xD; extension:interventionAssignmentMethod S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "interventionAssignmentMethod" #xD; value[x] 0..1 CodeableConcept C217280 Intervention Assignment Method Binding: ICH M11 ... (required) #xD; extension:randomisationType S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "randomisationType" #xD; value[x] 0..1 C223137 Randomisation Type #xD; valueString string #xD; valueCodeableConcept CodeableConcept #xD; extension:otherInterventionAssignmentMethod S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "otherInterventionAssignmentMethod" #xD; value[x] 0..1 string C223138 Other Intervention Assignment Method} #xD; extension:stratificationIndicator S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "stratificationIndicator" #xD; value[x] 0..1 CodeableConcept C223136 Stratification Indicator Binding: ICH M11 No Yes Value Set Terminology (required) #xD; extension:siteDistribution S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "siteDistribution" #xD; value[x] 0..1 CodeableConcept C217049 Site Distribution Binding: ICH M11 ... (required) #xD; extension:siteGeographicScope S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "siteGeographicScope" #xD; value[x] 0..1 CodeableConcept C217050: Site geographic scope Binding: ICH M11 ... (required) #xD; extension:masterProtocolIndicator S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "masterProtocolIndicator" #xD; value[x] 0..1 CodeableConcept C217046 Master Protocol Indicator Binding: ICH M11 No Yes Value Set Terminology (required) #xD; extension:drug-DeviceCombinationProductIndicator S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "drug-DeviceCombinationProductIndicator" #xD; value[x] 0..1 CodeableConcept C217046 Drug-Device Combination Product Indicator Binding: ICH M11 No Yes Value Set Terminology (required) #xD; extension:adaptiveTrialDesignIndicator S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "adaptiveTrialDesignIndicator" #xD; value[x] 0..1 CodeableConcept C217046 Adaptive Trial Design Indicator Binding: ICH M11 No Yes Value Set Terminology (required) #xD; extension:numberOfArms S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "numberOfArms" #xD; value[x] 0..1 integer C98771 Number of Arms #xD; extension:trialBlindSchema S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "trialBlindSchema" #xD; value[x] 0..1 CodeableConcept C217051 Trial Blind Schema Binding: ICH M11 ... (required) #xD; extension:blindedRoles S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "blindedRoles" #xD; value[x] 0..1 CodeableConcept C217281: Blinded Roles Binding: ICH M11 ... (required) #xD; extension:targetOrMaximum S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "targetOrMaximum" #xD; value[x] 0..1 CodeableConcept Target-Maximum Binding: UDP ... (required) #xD; extension:numberOfParticipants S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "numberOfParticipants" #xD; value[x] 0..1 integer C49692 Number of Participants #xD; extension:totalPlannedDurationOfTrialIntervention 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "totalPlannedDurationOfTrialIntervention" #xD; value[x] 0..1 time C218712/C218713 total planned duration of trial intervention value/units #xD; extension:totalPlannedDurationOfTrialInterventionUnitOfTime 1..1 Extension Extension #xD; url 1..1 uri "totalPlannedDurationOfTrialInterventionUnitOfTime" #xD; extension:alternateDescriptionOfPlannedDurationOfTrialIntervention 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialIntervention" #xD; value[x] 0..1 string C218714 alternate description of planned duration of trial intervention if duration will vary #xD; extension:totalPlannedDurationOfTrialParticipation 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "totalPlannedDurationOfTrialParticipation" #xD; value[x] 0..1 time C218715/C218716 total planned duration of trial participation value/units #xD; extension:totalPlannedDurationOfTrialParticipationUnitOfTime 1..1 Extension Extension #xD; url 1..1 uri "totalPlannedDurationOfTrialParticipationUnitOfTime" #xD; extension:alternateDescriptionOfPlannedDurationOfTrialParticipation 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "alternateDescriptionOfPlannedDurationOfTrialParticipation" #xD; value[x] 0..1 string C218717 alternate description of planned duration of trial participation if duration will vary #xD; extension:additionalDescriptionofDuration 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "additionalDescriptionofDuration" #xD; value[x] 0..1 string C218838 Additional Description of Duration #xD; extension:independentCommittees S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "independentCommittees" #xD; value[x] 0..1 CodeableConcept C217282 Independent Committees Binding: ICH M11 ... (required) #xD; extension:otherCommittees 1..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "otherCommittees" #xD; value[x] 0..1 string C218719 Other Committees #xD; extension:trialSchema S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "trialSchema" #xD; value[x] 0..1 string C93682 Trial Schema #xD; extension:schemaNotes 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "schemaNotes" #xD; value[x] 0..1 string C218720 Schema Notes #xD; extension:scheduleofActivities S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "scheduleofActivities" #xD; value[x] 0..1 string C132349 Schedule of Activities #xD; url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary" #xD; value[x] 0..0 Value of extension #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: [licenses.html](licenses.html)
Representation of summary of a study protocol.
This is Section 1 of the ICH Technical Summary and Guideline.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Must have either extensions or value[x], not both
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
C218839 Primary and Secondary Objectives and Estimands
A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.
The overall design configuration for assigning intervention to participants.
A characterisation or classification of the trial population.
A characterization or classification of the comparator against which the study intervention is evaluated.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).
The comparator against which the study intervention is evaluated.
M11 CC97054 requires on a narrative representation of the comparator - the name.
The anticipated minimum age of the participants to be entered in a clinical trial.
The anticipated maximum age of the participants to be entered in a clinical trial.
The process used to assign trial participants to a trial intervention or trial arm.
The type of randomisation to be used (e.g., simple randomisation, block randomisation)
this is just a text description - implementers may want to provide a value set that tehe text can be drawn from.
C223138 Other Intervention Assignment Method}
If applicable, describe the other intervention assignment method.
An indication as to whether the occurrence applies to a single or multiple trial sites.
An indication as to whether the trial is taking place in one or more countries.
An indication as to whether the protocol is a master protocol.
C217046 Drug-Device Combination Product Indicator
An indication as to whether the clinical trial is testing a drug-device combination product.
An indication as to whether the clinical trial uses an adaptive trial design.
The planned number of intervention groups.
The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.
An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function
A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.
The ICH spec has this as optional boilerplate text but it has to be a variable to be processable
The planned number of participant be entered in a clinical trial.
C218712/C218713 total planned duration of trial intervention value/units
The total planned duration of trial intervention
C218714 alternate description of planned duration of trial intervention if duration will vary
An alternative textual narrative for the planned duration of trial intervention.
C218715/C218716 total planned duration of trial participation value/units
The total planned duration of trial participation
C218717 alternate description of planned duration of trial participation if duration will vary
An alternative narrative for the planned duration of trial participation.
C218838 Additional Description of Duration
A narrative providing additional details about the duration of an participant's use of a trial intervention or their planned participation time in the trial.
An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.
A committee that is different than the one(s) previously specified or mentioned.
A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.
A brief written record describing the trial schematic.
The schedule of activities captures the procedures that will be accomplished at each trial visit, contact with participants. A tabular format is recommended.