Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Extension: ResearchStudyStudyAmendmentDetails - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the protocol-amendment-detail extension.

Guidance on how to interpret the contents of this table can be foundhere

0. Extension
Definition

Provides detail of a single amendment - repeats within the overal amendment report


Optional Extension Element - found in all resources.

ShortExtensionOptional Extensions Element
Control0..*
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2. Extension.extension
Definition

An Extension


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.

ShortExtensionAdditional content defined by implementations
Comments

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.

Control30..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. Extension.extension:detail
    Slice Namedetail
    Definition

    An Extension

    ShortExtensionAdditional content defined by implementations
    Control10..1*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. Extension.extension:detail.extension
    Definition

    An Extension


    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.

    ShortExtensionAdditional content defined by implementations
    Comments

    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.

    Control0..0*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 8. Extension.extension:detail.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      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.

      Control1..1
      Typeuri
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summarytrue
      Fixed Valuedetail
      10. Extension.extension:detail.value[x]
      Definition

      Statement regarding prior amendments.


      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      ShortStatement regarding prior amendmentsValue of extension
      Comments

      State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).

      Control0..1
      This element is affected by the following invariants: ext-1
      Typestring, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      12. Extension.extension:rationale
      Slice Namerationale
      Definition

      An Extension

      ShortExtensionAdditional content defined by implementations
      Control10..1*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. Extension.extension:rationale.extension
      Definition

      An Extension


      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.

      ShortExtensionAdditional content defined by implementations
      Comments

      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.

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 16. Extension.extension:rationale.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        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.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summarytrue
        Fixed Valuerationale
        18. Extension.extension:rationale.value[x]
        Definition

        Rationale.


        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortRationaleValue of extension
        Control0..1
        This element is affected by the following invariants: ext-1
        Typestring, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. Extension.extension:section
        Slice Namesection
        Definition

        An Extension

        ShortExtensionAdditional content defined by implementations
        Control10..1*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. Extension.extension:section.extension
        Definition

        An Extension


        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.

        ShortExtensionAdditional content defined by implementations
        Comments

        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.

        Control0..0*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 24. Extension.extension:section.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          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.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summarytrue
          Fixed Valuesection
          26. Extension.extension:section.value[x]
          Definition

          M11 Section where the amendment was made e.g. 1.2 Trial Schema.


          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

          ShortSection where the amendment was madeValue of extension
          Control0..1
          This element is affected by the following invariants: ext-1
          BindingThe codes SHALL be taken from For codes, see M11 Section Codes Value Set
          (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs)
          TypeCodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. Extension.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          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.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summarytrue
          Fixed Valuehttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
          30. Extension.value[x]
          Definition

          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

          ShortValue of extension
          Control0..01
          This element is affected by the following invariants: ext-1
          TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

          Guidance on how to interpret the contents of this table can be foundhere

          0. Extension
          Definition

          Provides detail of a single amendment - repeats within the overal amendment report

          2. Extension.extension
          Control3..?
          4. Extension.extension:detail
          Slice Namedetail
          Control1..1
          6. Extension.extension:detail.extension
          Control0..0
          8. Extension.extension:detail.url
          Fixed Valuedetail
          10. Extension.extension:detail.value[x]
          Definition

          Statement regarding prior amendments.

          ShortStatement regarding prior amendments
          Comments

          State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).

          Typestring
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          12. Extension.extension:rationale
          Slice Namerationale
          Control1..1
          14. Extension.extension:rationale.extension
          Control0..0
          16. Extension.extension:rationale.url
          Fixed Valuerationale
          18. Extension.extension:rationale.value[x]
          Definition

          Rationale.

          ShortRationale
          Typestring
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          20. Extension.extension:section
          Slice Namesection
          Control1..1
          22. Extension.extension:section.extension
          Control0..0
          24. Extension.extension:section.url
          Fixed Valuesection
          26. Extension.extension:section.value[x]
          Definition

          M11 Section where the amendment was made e.g. 1.2 Trial Schema.

          ShortSection where the amendment was made
          BindingThe codes SHALL be taken from M11 Section Codes Value Set
          (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs)
          TypeCodeableConcept
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          28. Extension.url
          Fixed Valuehttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
          30. Extension.value[x]
          Control0..0

          Guidance on how to interpret the contents of this table can be foundhere

          0. Extension
          Definition

          Provides detail of a single amendment - repeats within the overal amendment report

          ShortExtension
          Control0..*
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          2. Extension.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeid
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          4. Extension.extension
          Definition

          An Extension

          ShortExtension
          Control3..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 6. Extension.extension:detail
            Slice Namedetail
            Definition

            An Extension

            ShortExtension
            Control1..1
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            8. Extension.extension:detail.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            This element is affected by the following invariants: ele-1
            Typeid
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            10. Extension.extension:detail.extension
            Definition

            An Extension

            ShortExtension
            Control0..0
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 12. Extension.extension:detail.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              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.

              Control1..1
              Typeuri
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summarytrue
              Fixed Valuedetail
              14. Extension.extension:detail.value[x]
              Definition

              Statement regarding prior amendments.

              ShortStatement regarding prior amendments
              Comments

              State {Not applicable. This protocol has not been amended.} or state {This protocol has been amended previously. Details of prior amendments are presented in Prior Protocol Amendment(s).} or include Current Amendment details as appropriate (See instructions).

              Control0..1
              This element is affected by the following invariants: ext-1
              Typestring
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              16. Extension.extension:rationale
              Slice Namerationale
              Definition

              An Extension

              ShortExtension
              Control1..1
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              18. Extension.extension:rationale.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              20. Extension.extension:rationale.extension
              Definition

              An Extension

              ShortExtension
              Control0..0
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 22. Extension.extension:rationale.url
                Definition

                Source of the definition for the extension code - a logical name or a URL.

                Shortidentifies the meaning of the extension
                Comments

                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.

                Control1..1
                Typeuri
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summarytrue
                Fixed Valuerationale
                24. Extension.extension:rationale.value[x]
                Definition

                Rationale.

                ShortRationale
                Control0..1
                This element is affected by the following invariants: ext-1
                Typestring
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                26. Extension.extension:section
                Slice Namesection
                Definition

                An Extension

                ShortExtension
                Control1..1
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                28. Extension.extension:section.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typeid
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                30. Extension.extension:section.extension
                Definition

                An Extension

                ShortExtension
                Control0..0
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                SlicingThis element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 32. Extension.extension:section.url
                  Definition

                  Source of the definition for the extension code - a logical name or a URL.

                  Shortidentifies the meaning of the extension
                  Comments

                  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.

                  Control1..1
                  Typeuri
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summarytrue
                  Fixed Valuesection
                  34. Extension.extension:section.value[x]
                  Definition

                  M11 Section where the amendment was made e.g. 1.2 Trial Schema.

                  ShortSection where the amendment was made
                  Control0..1
                  This element is affected by the following invariants: ext-1
                  BindingThe codes SHALL be taken from M11 Section Codes Value Set
                  (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs)
                  TypeCodeableConcept
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  36. Extension.url
                  Definition

                  Source of the definition for the extension code - a logical name or a URL.

                  Shortidentifies the meaning of the extension
                  Comments

                  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.

                  Control1..1
                  Typeuri
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summarytrue
                  Fixed Valuehttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail
                  38. Extension.value[x]
                  Definition

                  Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                  ShortValue of extension
                  Control0..0
                  This element is affected by the following invariants: ext-1
                  TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))