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: M11_ProtocolAmendment - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the protocol-amendment extension.

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

0. Extension
Definition

Representation of amendments to a study protocol.


Optional Extension Element - found in all resources.

ShortAmendment to a protocol - from EBMOptional Extensions Element
Comments

The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.

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.

Control10..*
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:scope
    Slice Namescope
    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:scope.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:scope.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 Valuescope
      10. Extension.extension:scope.value[x]
      Definition

      C218673 Global, Country, Region, or Site.


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

      ShortGlobal, Not GlobalValue of extension
      Comments

      If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).

      Control0..1
      This element is affected by the following invariants: ext-1
      BindingUnless not suitable, these codes SHALL be taken from For codes, see Study Amendment Scope Value Set
      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs)
      Typecode, 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, 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
      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:country
      Slice Namecountry
      Definition

      An Extension

      ShortExtensionAdditional content defined by implementations
      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. Extension.extension:country.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:country.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 Valuecountry
        18. Extension.extension:country.value[x]
        Definition

        C20108


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

        ShortValue of extension
        Control0..1
        This element is affected by the following invariants: ext-1
        BindingUnless not suitable, these codes SHALL be taken from For codes, see Study Amendment Country Value Set
        (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs)
        Typecode, 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, 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
        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:region
        Slice Nameregion
        Definition

        An Extension

        ShortExtensionAdditional content defined by implementations
        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. Extension.extension:region.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:region.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 Valueregion
          26. Extension.extension:region.value[x]
          Definition

          C218674


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

          ShortValue of extension
          Control0..1
          This element is affected by the following invariants: ext-1
          BindingUnless not suitable, these codes SHALL be taken from For codes, see Study Amendment Country Value Set
          (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs)
          Typecode, 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, 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
          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()))
          28. Extension.extension:site
          Slice Namesite
          Definition

          An Extension

          ShortExtensionAdditional content defined by implementations
          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. Extension.extension:site.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
          • 32. Extension.extension:site.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 Valuesite
            34. Extension.extension:site.value[x]
            Definition

            C83081


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

            ShortValue of extension
            Control0..1
            This element is affected by the following invariants: ext-1
            TypeIdentifier, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, 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()))
            36. Extension.extension:approvalDate
            Slice NameapprovalDate
            Definition

            An Extension

            ShortExtensionAdditional content defined by implementations
            Control0..1*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            38. Extension.extension:approvalDate.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
            • 40. Extension.extension:approvalDate.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 ValueapprovalDate
              42. Extension.extension:approvalDate.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..1
              This element is affected by the following invariants: ext-1
              Typedate, 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, 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
              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()))
              44. Extension.extension:signature
              Slice Namesignature
              Definition

              An Extension

              ShortExtensionAdditional content defined by implementations
              Control0..1*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              46. Extension.extension:signature.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
              • 48. Extension.extension:signature.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 Valuesignature
                50. Extension.extension:signature.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
                Comments

                //TODO Need to review the example

                Control0..1
                This element is affected by the following invariants: ext-1
                TypeSignature, 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, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, 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()))
                52. Extension.extension:signatureURL
                Slice NamesignatureURL
                Definition

                An Extension

                ShortExtensionAdditional content defined by implementations
                Control0..1*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                54. Extension.extension:signatureURL.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
                • 56. Extension.extension:signatureURL.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 ValuesignatureURL
                  58. Extension.extension:signatureURL.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..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()))
                  60. Extension.extension:signatureMethod
                  Slice NamesignatureMethod
                  Definition

                  An Extension

                  ShortExtensionAdditional content defined by implementations
                  Control0..1*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  62. Extension.extension:signatureMethod.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
                  • 64. Extension.extension:signatureMethod.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 ValuesignatureMethod
                    66. Extension.extension:signatureMethod.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..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()))
                    68. Extension.extension:scopeImpact
                    Slice NamescopeImpact
                    Definition

                    Provides number or percentage of each group affected by a single amendment

                    ShortExtension
                    Control0..3
                    TypeExtension(ResearchStudyStudyAmendmentScopeImpact) (Complex Extension)
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    70. Extension.extension:primaryReason
                    Slice NameprimaryReason
                    Definition

                    An Extension

                    ShortExtensionAdditional content defined by implementations
                    Control0..1*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    72. Extension.extension:primaryReason.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
                    • 74. Extension.extension:primaryReason.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 ValueprimaryReason
                      76. Extension.extension:primaryReason.value[x]
                      Definition

                      Reason for amendment, e.g. Safety.


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

                      ShortReason for amendment, e.g. SafetyValue of extension
                      Control0..1
                      This element is affected by the following invariants: ext-1
                      BindingUnless not suitable, these codes SHALL be taken from For codes, see Study Amendment Reason Value Set
                      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-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()))
                      78. Extension.extension:secondaryReason
                      Slice NamesecondaryReason
                      Definition

                      An Extension

                      ShortExtensionAdditional content defined by implementations
                      Control0..1*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      80. Extension.extension:secondaryReason.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
                      • 82. Extension.extension:secondaryReason.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 ValuesecondaryReason
                        84. Extension.extension:secondaryReason.value[x]
                        Definition

                        Reason for amendment, e.g. Manufacturing change.


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

                        ShortReason for amendment, e.g. Manufacturing changeValue of extension
                        Control0..1
                        This element is affected by the following invariants: ext-1
                        BindingUnless not suitable, these codes SHALL be taken from For codes, see Study Amendment Reason Value Set
                        (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-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()))
                        86. Extension.extension:summary
                        Slice Namesummary
                        Definition

                        An Extension

                        ShortExtensionAdditional content defined by implementations
                        Control0..1*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        88. Extension.extension:summary.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
                        • 90. Extension.extension:summary.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 Valuesummary
                          92. Extension.extension:summary.value[x]
                          Definition

                          Summary of amendmets.


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

                          Shortsummary of changesValue 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()))
                          94. Extension.extension:substantialImpactSafety
                          Slice NamesubstantialImpactSafety
                          Definition

                          An Extension

                          ShortExtensionAdditional content defined by implementations
                          Control0..1*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          96. Extension.extension:substantialImpactSafety.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
                          • 98. Extension.extension:substantialImpactSafety.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 ValuesubstantialImpactSafety
                            100. Extension.extension:substantialImpactSafety.value[x]
                            Definition

                            Substantial impact on safety.


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

                            ShortSubstantial impact on safetyValue of extension
                            Control0..1
                            This element is affected by the following invariants: ext-1
                            BindingThe codes SHALL be taken from For codes, see CDISC Yes No Unknown Not Applicable Value Set
                            (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs)
                            Typecode, 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, 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
                            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()))
                            102. Extension.extension:substantialImpactSafetyComment
                            Slice NamesubstantialImpactSafetyComment
                            Definition

                            An Extension

                            ShortExtensionAdditional content defined by implementations
                            Control0..1*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            104. Extension.extension:substantialImpactSafetyComment.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
                            • 106. Extension.extension:substantialImpactSafetyComment.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 ValuesubstantialImpactSafetyComment
                              108. Extension.extension:substantialImpactSafetyComment.value[x]
                              Definition

                              Comment on substantial impact on safety.


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

                              ShortComment on substantial impact on safetyValue 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()))
                              110. Extension.extension:substantialImpactReliability
                              Slice NamesubstantialImpactReliability
                              Definition

                              An Extension

                              ShortExtensionAdditional content defined by implementations
                              Control0..1*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              112. Extension.extension:substantialImpactReliability.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
                              • 114. Extension.extension:substantialImpactReliability.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 ValuesubstantialImpactReliability
                                116. Extension.extension:substantialImpactReliability.value[x]
                                Definition

                                Substantial impact on reliability.


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

                                ShortSubstantial impact on reliabilityValue of extension
                                Control0..1
                                This element is affected by the following invariants: ext-1
                                BindingThe codes SHALL be taken from For codes, see CDISC Yes No Unknown Not Applicable Value Set
                                (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs)
                                Typecode, 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, 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
                                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()))
                                118. Extension.extension:substantialImpactReliabilityComment
                                Slice NamesubstantialImpactReliabilityComment
                                Definition

                                An Extension

                                ShortExtensionAdditional content defined by implementations
                                Control0..1*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                120. Extension.extension:substantialImpactReliabilityComment.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
                                • 122. Extension.extension:substantialImpactReliabilityComment.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 ValuesubstantialImpactReliabilityComment
                                  124. Extension.extension:substantialImpactReliabilityComment.value[x]
                                  Definition

                                  Comment on substantial impact on reliability.


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

                                  ShortComment on substantial impact on reliabilityValue 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()))
                                  126. Extension.extension:details
                                  Slice Namedetails
                                  Definition

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

                                  ShortExtension
                                  Control0..*
                                  TypeExtension(ResearchStudyStudyAmendmentDetails) (Complex Extension)
                                  Is Modifierfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  128. Extension.extension:rationale
                                  Slice Namerationale
                                  Definition

                                  An Extension

                                  ShortExtensionAdditional content defined by implementations
                                  Control0..1*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  130. 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
                                  • 132. 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
                                    134. Extension.extension:rationale.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..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()))
                                    136. Extension.extension:description
                                    Slice Namedescription
                                    Definition

                                    An Extension

                                    ShortExtensionAdditional content defined by implementations
                                    Control0..1*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    138. Extension.extension:description.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
                                    • 140. Extension.extension:description.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 Valuedescription
                                      142. Extension.extension:description.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..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()))
                                      144. 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
                                      146. 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

                                      Representation of amendments to a study protocol.

                                      ShortAmendment to a protocol - from EBM
                                      Comments

                                      The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.

                                      2. Extension.extension
                                      Control1..?
                                      4. Extension.extension:scope
                                      Slice Namescope
                                      Control1..1
                                      6. Extension.extension:scope.extension
                                      Control0..0
                                      8. Extension.extension:scope.url
                                      Fixed Valuescope
                                      10. Extension.extension:scope.value[x]
                                      Definition

                                      C218673 Global, Country, Region, or Site.

                                      ShortGlobal, Not Global
                                      Comments

                                      If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).

                                      BindingUnless not suitable, these codes SHALL be taken from Study Amendment Scope Value Set
                                      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs)
                                      Typecode
                                      [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:country
                                      Slice Namecountry
                                      Control0..*
                                      14. Extension.extension:country.extension
                                      Control0..0
                                      16. Extension.extension:country.url
                                      Fixed Valuecountry
                                      18. Extension.extension:country.value[x]
                                      Definition

                                      C20108

                                      BindingUnless not suitable, these codes SHALL be taken from Study Amendment Country Value Set
                                      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs)
                                      Typecode
                                      [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:region
                                      Slice Nameregion
                                      Control0..*
                                      22. Extension.extension:region.extension
                                      Control0..0
                                      24. Extension.extension:region.url
                                      Fixed Valueregion
                                      26. Extension.extension:region.value[x]
                                      Definition

                                      C218674

                                      BindingUnless not suitable, these codes SHALL be taken from Study Amendment Country Value Set
                                      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs)
                                      Typecode
                                      [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
                                      28. Extension.extension:site
                                      Slice Namesite
                                      Control0..*
                                      30. Extension.extension:site.extension
                                      Control0..0
                                      32. Extension.extension:site.url
                                      Fixed Valuesite
                                      34. Extension.extension:site.value[x]
                                      Definition

                                      C83081

                                      TypeIdentifier
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      36. Extension.extension:approvalDate
                                      Slice NameapprovalDate
                                      Control0..1
                                      38. Extension.extension:approvalDate.extension
                                      Control0..0
                                      40. Extension.extension:approvalDate.url
                                      Fixed ValueapprovalDate
                                      42. Extension.extension:approvalDate.value[x]
                                      Typedate
                                      [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
                                      44. Extension.extension:signature
                                      Slice Namesignature
                                      Control0..1
                                      46. Extension.extension:signature.extension
                                      Control0..0
                                      48. Extension.extension:signature.url
                                      Fixed Valuesignature
                                      50. Extension.extension:signature.value[x]
                                      Comments

                                      //TODO Need to review the example

                                      TypeSignature
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      52. Extension.extension:signatureURL
                                      Slice NamesignatureURL
                                      Control0..1
                                      54. Extension.extension:signatureURL.extension
                                      Control0..0
                                      56. Extension.extension:signatureURL.url
                                      Fixed ValuesignatureURL
                                      58. Extension.extension:signatureURL.value[x]
                                      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
                                      60. Extension.extension:signatureMethod
                                      Slice NamesignatureMethod
                                      Control0..1
                                      62. Extension.extension:signatureMethod.extension
                                      Control0..0
                                      64. Extension.extension:signatureMethod.url
                                      Fixed ValuesignatureMethod
                                      66. Extension.extension:signatureMethod.value[x]
                                      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
                                      68. Extension.extension:scopeImpact
                                      Slice NamescopeImpact
                                      Control0..3
                                      TypeExtension(ResearchStudyStudyAmendmentScopeImpact) (Complex Extension)
                                      70. Extension.extension:primaryReason
                                      Slice NameprimaryReason
                                      Control0..1
                                      72. Extension.extension:primaryReason.extension
                                      Control0..0
                                      74. Extension.extension:primaryReason.url
                                      Fixed ValueprimaryReason
                                      76. Extension.extension:primaryReason.value[x]
                                      Definition

                                      Reason for amendment, e.g. Safety.

                                      ShortReason for amendment, e.g. Safety
                                      BindingUnless not suitable, these codes SHALL be taken from Study Amendment Reason Value Set
                                      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs)
                                      TypeCodeableConcept
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      78. Extension.extension:secondaryReason
                                      Slice NamesecondaryReason
                                      Control0..1
                                      80. Extension.extension:secondaryReason.extension
                                      Control0..0
                                      82. Extension.extension:secondaryReason.url
                                      Fixed ValuesecondaryReason
                                      84. Extension.extension:secondaryReason.value[x]
                                      Definition

                                      Reason for amendment, e.g. Manufacturing change.

                                      ShortReason for amendment, e.g. Manufacturing change
                                      BindingUnless not suitable, these codes SHALL be taken from Study Amendment Reason Value Set
                                      (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs)
                                      TypeCodeableConcept
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      86. Extension.extension:summary
                                      Slice Namesummary
                                      Control0..1
                                      88. Extension.extension:summary.extension
                                      Control0..0
                                      90. Extension.extension:summary.url
                                      Fixed Valuesummary
                                      92. Extension.extension:summary.value[x]
                                      Definition

                                      Summary of amendmets.

                                      Shortsummary of changes
                                      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
                                      94. Extension.extension:substantialImpactSafety
                                      Slice NamesubstantialImpactSafety
                                      Control0..1
                                      96. Extension.extension:substantialImpactSafety.extension
                                      Control0..0
                                      98. Extension.extension:substantialImpactSafety.url
                                      Fixed ValuesubstantialImpactSafety
                                      100. Extension.extension:substantialImpactSafety.value[x]
                                      Definition

                                      Substantial impact on safety.

                                      ShortSubstantial impact on safety
                                      BindingThe codes SHALL be taken from CDISC Yes No Unknown Not Applicable Value Set
                                      (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs)
                                      Typecode
                                      [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
                                      102. Extension.extension:substantialImpactSafetyComment
                                      Slice NamesubstantialImpactSafetyComment
                                      Control0..1
                                      104. Extension.extension:substantialImpactSafetyComment.extension
                                      Control0..0
                                      106. Extension.extension:substantialImpactSafetyComment.url
                                      Fixed ValuesubstantialImpactSafetyComment
                                      108. Extension.extension:substantialImpactSafetyComment.value[x]
                                      Definition

                                      Comment on substantial impact on safety.

                                      ShortComment on substantial impact on safety
                                      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
                                      110. Extension.extension:substantialImpactReliability
                                      Slice NamesubstantialImpactReliability
                                      Control0..1
                                      112. Extension.extension:substantialImpactReliability.extension
                                      Control0..0
                                      114. Extension.extension:substantialImpactReliability.url
                                      Fixed ValuesubstantialImpactReliability
                                      116. Extension.extension:substantialImpactReliability.value[x]
                                      Definition

                                      Substantial impact on reliability.

                                      ShortSubstantial impact on reliability
                                      BindingThe codes SHALL be taken from CDISC Yes No Unknown Not Applicable Value Set
                                      (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs)
                                      Typecode
                                      [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
                                      118. Extension.extension:substantialImpactReliabilityComment
                                      Slice NamesubstantialImpactReliabilityComment
                                      Control0..1
                                      120. Extension.extension:substantialImpactReliabilityComment.extension
                                      Control0..0
                                      122. Extension.extension:substantialImpactReliabilityComment.url
                                      Fixed ValuesubstantialImpactReliabilityComment
                                      124. Extension.extension:substantialImpactReliabilityComment.value[x]
                                      Definition

                                      Comment on substantial impact on reliability.

                                      ShortComment on substantial impact on reliability
                                      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
                                      126. Extension.extension:details
                                      Slice Namedetails
                                      Control0..*
                                      TypeExtension(ResearchStudyStudyAmendmentDetails) (Complex Extension)
                                      128. Extension.extension:rationale
                                      Slice Namerationale
                                      Control0..1
                                      130. Extension.extension:rationale.extension
                                      Control0..0
                                      132. Extension.extension:rationale.url
                                      Fixed Valuerationale
                                      134. Extension.extension:rationale.value[x]
                                      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
                                      136. Extension.extension:description
                                      Slice Namedescription
                                      Control0..1
                                      138. Extension.extension:description.extension
                                      Control0..0
                                      140. Extension.extension:description.url
                                      Fixed Valuedescription
                                      142. Extension.extension:description.value[x]
                                      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
                                      144. Extension.url
                                      Fixed Valuehttp://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment
                                      146. Extension.value[x]
                                      Control0..0

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

                                      0. Extension
                                      Definition

                                      Representation of amendments to a study protocol.

                                      ShortAmendment to a protocol - from EBM
                                      Comments

                                      The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.

                                      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
                                      Control1..*
                                      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:scope
                                        Slice Namescope
                                        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:scope.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:scope.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:scope.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 Valuescope
                                          14. Extension.extension:scope.value[x]
                                          Definition

                                          C218673 Global, Country, Region, or Site.

                                          ShortGlobal, Not Global
                                          Comments

                                          If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).

                                          Control0..1
                                          This element is affected by the following invariants: ext-1
                                          BindingUnless not suitable, these codes SHALL be taken from Study Amendment Scope Value Set
                                          (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-scope-vs)
                                          Typecode
                                          [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:country
                                          Slice Namecountry
                                          Definition

                                          An Extension

                                          ShortExtension
                                          Control0..*
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          18. Extension.extension:country.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:country.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:country.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 Valuecountry
                                            24. Extension.extension:country.value[x]
                                            Definition

                                            C20108

                                            ShortValue of extension
                                            Control0..1
                                            This element is affected by the following invariants: ext-1
                                            BindingUnless not suitable, these codes SHALL be taken from Study Amendment Country Value Set
                                            (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs)
                                            Typecode
                                            [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:region
                                            Slice Nameregion
                                            Definition

                                            An Extension

                                            ShortExtension
                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            28. Extension.extension:region.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:region.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:region.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 Valueregion
                                              34. Extension.extension:region.value[x]
                                              Definition

                                              C218674

                                              ShortValue of extension
                                              Control0..1
                                              This element is affected by the following invariants: ext-1
                                              BindingUnless not suitable, these codes SHALL be taken from Study Amendment Country Value Set
                                              (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-country-region-vs)
                                              Typecode
                                              [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()))
                                              36. Extension.extension:site
                                              Slice Namesite
                                              Definition

                                              An Extension

                                              ShortExtension
                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              38. Extension.extension:site.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
                                              40. Extension.extension:site.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
                                              • 42. Extension.extension:site.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 Valuesite
                                                44. Extension.extension:site.value[x]
                                                Definition

                                                C83081

                                                ShortValue of extension
                                                Control0..1
                                                This element is affected by the following invariants: ext-1
                                                TypeIdentifier
                                                [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()))
                                                46. Extension.extension:approvalDate
                                                Slice NameapprovalDate
                                                Definition

                                                An Extension

                                                ShortExtension
                                                Control0..1
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                48. Extension.extension:approvalDate.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
                                                50. Extension.extension:approvalDate.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
                                                • 52. Extension.extension:approvalDate.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 ValueapprovalDate
                                                  54. Extension.extension:approvalDate.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..1
                                                  This element is affected by the following invariants: ext-1
                                                  Typedate
                                                  [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()))
                                                  56. Extension.extension:signature
                                                  Slice Namesignature
                                                  Definition

                                                  An Extension

                                                  ShortExtension
                                                  Control0..1
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  58. Extension.extension:signature.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
                                                  60. Extension.extension:signature.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
                                                  • 62. Extension.extension:signature.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 Valuesignature
                                                    64. Extension.extension:signature.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
                                                    Comments

                                                    //TODO Need to review the example

                                                    Control0..1
                                                    This element is affected by the following invariants: ext-1
                                                    TypeSignature
                                                    [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()))
                                                    66. Extension.extension:signatureURL
                                                    Slice NamesignatureURL
                                                    Definition

                                                    An Extension

                                                    ShortExtension
                                                    Control0..1
                                                    TypeExtension
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    68. Extension.extension:signatureURL.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
                                                    70. Extension.extension:signatureURL.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
                                                    • 72. Extension.extension:signatureURL.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 ValuesignatureURL
                                                      74. Extension.extension:signatureURL.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..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()))
                                                      76. Extension.extension:signatureMethod
                                                      Slice NamesignatureMethod
                                                      Definition

                                                      An Extension

                                                      ShortExtension
                                                      Control0..1
                                                      TypeExtension
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      78. Extension.extension:signatureMethod.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
                                                      80. Extension.extension:signatureMethod.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
                                                      • 82. Extension.extension:signatureMethod.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 ValuesignatureMethod
                                                        84. Extension.extension:signatureMethod.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..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()))
                                                        86. Extension.extension:scopeImpact
                                                        Slice NamescopeImpact
                                                        Definition

                                                        Provides number or percentage of each group affected by a single amendment

                                                        ShortExtension
                                                        Control0..3
                                                        TypeExtension(ResearchStudyStudyAmendmentScopeImpact) (Complex Extension)
                                                        Is Modifierfalse
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        88. Extension.extension:primaryReason
                                                        Slice NameprimaryReason
                                                        Definition

                                                        An Extension

                                                        ShortExtension
                                                        Control0..1
                                                        TypeExtension
                                                        Is Modifierfalse
                                                        Summaryfalse
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        90. Extension.extension:primaryReason.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
                                                        92. Extension.extension:primaryReason.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
                                                        • 94. Extension.extension:primaryReason.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 ValueprimaryReason
                                                          96. Extension.extension:primaryReason.value[x]
                                                          Definition

                                                          Reason for amendment, e.g. Safety.

                                                          ShortReason for amendment, e.g. Safety
                                                          Control0..1
                                                          This element is affected by the following invariants: ext-1
                                                          BindingUnless not suitable, these codes SHALL be taken from Study Amendment Reason Value Set
                                                          (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-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()))
                                                          98. Extension.extension:secondaryReason
                                                          Slice NamesecondaryReason
                                                          Definition

                                                          An Extension

                                                          ShortExtension
                                                          Control0..1
                                                          TypeExtension
                                                          Is Modifierfalse
                                                          Summaryfalse
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          100. Extension.extension:secondaryReason.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
                                                          102. Extension.extension:secondaryReason.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
                                                          • 104. Extension.extension:secondaryReason.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 ValuesecondaryReason
                                                            106. Extension.extension:secondaryReason.value[x]
                                                            Definition

                                                            Reason for amendment, e.g. Manufacturing change.

                                                            ShortReason for amendment, e.g. Manufacturing change
                                                            Control0..1
                                                            This element is affected by the following invariants: ext-1
                                                            BindingUnless not suitable, these codes SHALL be taken from Study Amendment Reason Value Set
                                                            (extensible to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-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()))
                                                            108. Extension.extension:summary
                                                            Slice Namesummary
                                                            Definition

                                                            An Extension

                                                            ShortExtension
                                                            Control0..1
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            110. Extension.extension:summary.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
                                                            112. Extension.extension:summary.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
                                                            • 114. Extension.extension:summary.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 Valuesummary
                                                              116. Extension.extension:summary.value[x]
                                                              Definition

                                                              Summary of amendmets.

                                                              Shortsummary of changes
                                                              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()))
                                                              118. Extension.extension:substantialImpactSafety
                                                              Slice NamesubstantialImpactSafety
                                                              Definition

                                                              An Extension

                                                              ShortExtension
                                                              Control0..1
                                                              TypeExtension
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              120. Extension.extension:substantialImpactSafety.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
                                                              122. Extension.extension:substantialImpactSafety.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
                                                              • 124. Extension.extension:substantialImpactSafety.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 ValuesubstantialImpactSafety
                                                                126. Extension.extension:substantialImpactSafety.value[x]
                                                                Definition

                                                                Substantial impact on safety.

                                                                ShortSubstantial impact on safety
                                                                Control0..1
                                                                This element is affected by the following invariants: ext-1
                                                                BindingThe codes SHALL be taken from CDISC Yes No Unknown Not Applicable Value Set
                                                                (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs)
                                                                Typecode
                                                                [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()))
                                                                128. Extension.extension:substantialImpactSafetyComment
                                                                Slice NamesubstantialImpactSafetyComment
                                                                Definition

                                                                An Extension

                                                                ShortExtension
                                                                Control0..1
                                                                TypeExtension
                                                                Is Modifierfalse
                                                                Summaryfalse
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                130. Extension.extension:substantialImpactSafetyComment.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
                                                                132. Extension.extension:substantialImpactSafetyComment.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
                                                                • 134. Extension.extension:substantialImpactSafetyComment.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 ValuesubstantialImpactSafetyComment
                                                                  136. Extension.extension:substantialImpactSafetyComment.value[x]
                                                                  Definition

                                                                  Comment on substantial impact on safety.

                                                                  ShortComment on substantial impact on safety
                                                                  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()))
                                                                  138. Extension.extension:substantialImpactReliability
                                                                  Slice NamesubstantialImpactReliability
                                                                  Definition

                                                                  An Extension

                                                                  ShortExtension
                                                                  Control0..1
                                                                  TypeExtension
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  140. Extension.extension:substantialImpactReliability.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
                                                                  142. Extension.extension:substantialImpactReliability.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
                                                                  • 144. Extension.extension:substantialImpactReliability.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 ValuesubstantialImpactReliability
                                                                    146. Extension.extension:substantialImpactReliability.value[x]
                                                                    Definition

                                                                    Substantial impact on reliability.

                                                                    ShortSubstantial impact on reliability
                                                                    Control0..1
                                                                    This element is affected by the following invariants: ext-1
                                                                    BindingThe codes SHALL be taken from CDISC Yes No Unknown Not Applicable Value Set
                                                                    (required to http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/cdisc-yes-no-vs)
                                                                    Typecode
                                                                    [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()))
                                                                    148. Extension.extension:substantialImpactReliabilityComment
                                                                    Slice NamesubstantialImpactReliabilityComment
                                                                    Definition

                                                                    An Extension

                                                                    ShortExtension
                                                                    Control0..1
                                                                    TypeExtension
                                                                    Is Modifierfalse
                                                                    Summaryfalse
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    150. Extension.extension:substantialImpactReliabilityComment.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
                                                                    152. Extension.extension:substantialImpactReliabilityComment.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
                                                                    • 154. Extension.extension:substantialImpactReliabilityComment.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 ValuesubstantialImpactReliabilityComment
                                                                      156. Extension.extension:substantialImpactReliabilityComment.value[x]
                                                                      Definition

                                                                      Comment on substantial impact on reliability.

                                                                      ShortComment on substantial impact on reliability
                                                                      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()))
                                                                      158. Extension.extension:details
                                                                      Slice Namedetails
                                                                      Definition

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

                                                                      ShortExtension
                                                                      Control0..*
                                                                      TypeExtension(ResearchStudyStudyAmendmentDetails) (Complex Extension)
                                                                      Is Modifierfalse
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      160. Extension.extension:rationale
                                                                      Slice Namerationale
                                                                      Definition

                                                                      An Extension

                                                                      ShortExtension
                                                                      Control0..1
                                                                      TypeExtension
                                                                      Is Modifierfalse
                                                                      Summaryfalse
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      162. 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
                                                                      164. 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
                                                                      • 166. 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
                                                                        168. Extension.extension:rationale.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..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()))
                                                                        170. Extension.extension:description
                                                                        Slice Namedescription
                                                                        Definition

                                                                        An Extension

                                                                        ShortExtension
                                                                        Control0..1
                                                                        TypeExtension
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        172. Extension.extension:description.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
                                                                        174. Extension.extension:description.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
                                                                        • 176. Extension.extension:description.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 Valuedescription
                                                                          178. Extension.extension:description.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..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()))
                                                                          180. 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
                                                                          182. 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()))