A set of healthcare-related information that is assembled together into a single logical package that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. A Composition defines the structure and narrative content necessary for a document. However, a Composition alone does not constitute a document. Rather, the Composition must be the first entry in a Bundle where Bundle.type=document, and any other resources referenced from Composition must be included as subsequent entries in the Bundle (for example Patient, Practitioner, Encounter, etc.).

While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.

Indicates the mechanism used to compare versions to determine which is more current.

If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.

A Boolean value to indicate that this artifact is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.

A free text natural language description of the artifact from a consumer's perspective.

This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the artifact as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the artifact is presumed to be the predominant language in the place the artifact was created).

Explanation of why this artifact is needed and why it has been designed as it has.

This element does not describe the usage of the artifact. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this artifact.

A copyright statement relating to the artifact and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the artifact.

The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.

A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').

Defines the content expected to be rendered in all representations of the artifact. The (c) symbol should NOT be included in this string. It is expected to be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.

The date on which the asset content was approved by the publisher. Approval happens once when the content is officially approved for usage.

The date may be more recent than the approval date because of minor changes / editorial corrections.

The date on which the asset content was last reviewed. Review happens periodically after that, but doesn't change the original approval date.

If specified, this is usually after the approval date.

The period during which the resource content was or is planned to be effective.

The effective period for a resource determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 would be published in 2015.

The Resource contains content in a language additional to the one in the language element.

Contact details to assist a user in finding and communicating with the publisher.

May be a web site, an email address, a physical address, a telephone number, etc.

Specifies the publication date of the Resource.

The status of the processing for making the artifact publicly available, not necessarily the same as artifact status (Resource.status).

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document.

If a composition is marked as withdrawn, the compositions/documents in the series, or data from the composition or document series, should never be displayed to a user without being clearly marked as untrustworthy. The flag "entered-in-error" is why this element is labeled as a modifier of other elements.

Some reporting work flows require that the original narrative of a final document never be altered; instead, only new narrative can be added. The composition resource has no explicit status for explicitly noting whether this business rule is in effect. This would be handled by an extension if required.

The workflow/clinical status of the composition.

Need to be able to mark interim, amended, or withdrawn compositions or documents.

Specifies the particular kind of composition (e.g. History and Physical, Discharge Summary, Progress Note). This usually equates to the purpose of making the composition.

For Composition type, LOINC is ubiquitous and strongly endorsed by HL7. Most implementation guides will require a specific LOINC code, or use LOINC as an extensible binding.

Type of a composition.

Key metadata element describing the composition, used in searching/filtering.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type.

High-level kind of a clinical document at a macro level.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type.

High-level kind of a clinical document at a macro level.

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

The composition editing time, when the composition was last logically changed by the author.

The Last Modified Date on the composition may be after the date of the document was attested without being changed. This means that the date on an amended document is the date of the amendment, not the date of original authorship.

dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, Bundle.timestamp is the date of packaging.

Identifies who is responsible for the information in the composition, not necessarily who typed it in.

Identifies who is responsible for the content.

Official human-readable label for the composition.

For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a "consultation" or "progress note"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.

To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.
When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource.
Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier:

"relatesTo": [{
  "type": "replaces",
  "targetReference": {
    "identifier": { 
      "system": "...", 
      "value": "..."
    }
  } 
}]

Provides additional classifiers of the related artifact.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The type of relationship to the related artifact.

The type of relationship to the related artifact.

The artifact that is related to this Composition Resource.

The root of the sections that make up the composition.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

The root of the sections that make up the composition.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

No text is intended here (heading only).

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

Describe the overall trial design and intervention model (e.g., single group, parallel group, cross-over, factorial, sequential), the expected number of participants, and the control method (e.g., placebo, active comparator, low dose, external, standard of care, sham procedure, or none [uncontrolled]). If there are any key aspects of the investigational trial intervention that inform the selection of the intervention model, this should be described. If applicable, indicate other design characteristics (e.g., superiority, noninferiority, dose escalation, or equivalence). If the trial will have an adaptive or novel design (e.g., the trial will be conducted under a master protocol), provide a summary of these design aspects. If applicable, describe within-trial transition rules, e.g., transitions involving cohorts or trial parts. Dose escalation or dose-ranging details should also be described. Describe the trial duration with reference to Section 1.2 Trial Schema. Explain what the overall duration for an individual participant is anticipated to be and why, including the sequence and duration of trial periods (e.g., screening, run-in, randomisation, treatment [fixed dose/titration], follow-up/washout periods). Where applicable, include discussion of sentinel dosing (or lack thereof), dose escalation, and cohort expansion. If dose modification decisions are dependent upon review by a committee, include details in Section 11.4 Committees. State the method of assignment to trial intervention the level and method of blinding that will be used with reference to Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding. Describe any other important aspects of the design, e.g.: • geographic scope of trial (e.g., single-centre, multi-centre, or multi-centre and multi-national) • use of decentralised processes, tools, or features in the trial • planned use of a Data Monitoring Committee, or similar review group and cross reference Section 11.4 Committees, for details • whether an interim analysis is planned; if so, refer to details in Section 10.9 Interim Analyses • any planned extension trial, long-term follow-up/registry, planned future use of samples or data, or post-trial sample analysis or other data-related activities

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

If applicable, describe any stakeholder (for example, patient, healthcare professional and patient advocacy groups) involvement in the design of the trial and any suggestions implemented.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

Enter Overall Rationale for Trial Design if not using below optional subheadings.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

When estimands are associated with the Primary and Secondary Objectives described in Section 3 Trial Objectives and Associated Estimands, provide a rationale for the estimand(s) not described elsewhere in the document. This should include a rationale that the selected endpoint(s) are clinically relevant and provide a reliable and valid measurement of the intended intervention effect. It should also include a rationale for the selected strategies for handling intercurrent events.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

Provide a rationale for the trial intervention model described in Section 4.1 Description of Trial Design with a cross reference to Section 6.2 Rationale for Investigational Intervention Dose and Regimen. Rationale for choice of comparator, if applicable, should be described separately in Section 4.2.5 Rationale for Control Type. A rationale for the choice of trial population should be described separately in Section 5.1 Description of Trial Population and Rationale.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

If applicable, provide a rationale for the type and choice of control selected for the trial (e.g., placebo, active drug, combination, external). Describe any known or potential problems associated with the control group selected in light of the specific disease and intervention(s) being studied. If comparators will differ by region, describe. The rationale for dose/dose regimen is explained in Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

Provide a rationale that the trial duration is appropriate for a reliable and relevant evaluation of the trial intervention per the trial objective(s).

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

If applicable, provide a rationale for the use of an adaptive or novel design.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.

A nested sub-section within this section.

Nested sections are primarily used to help human readers navigate to particular portions of the document.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

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.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.

The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

If applicable, provide a rationale for any interim analysis planned with respect to its purpose (for example, stopping the trial early for efficacy or futility) and timing.

A reference to the actual resource from which the narrative in the section is derived.

If there are no entries in the list, an emptyReason SHOULD be provided.