FHIRsmith: StructureDefinition/StructureDefinition-m11-protocol-amendment.json

FHIR IG analytics

Package	hl7.fhir.uv.clinical-study-protocol
Resource Type	StructureDefinition
Id	StructureDefinition-m11-protocol-amendment.json
FHIR Version	R6
Source	https://build.fhir.org/ig/HL7/vulcan-udp-ig/StructureDefinition-m11-protocol-amendment.html
URL	http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
Version	1.0.0-ballot2
Status	active
Date	2026-06-22T17:54:57+00:00
Name	M11_ProtocolAmendment
Realm	uv
Authority	hl7
Description	Amendment to a protocol. This is originally from EBM.
Copyright	Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: [licenses.html](licenses.html)
Type	Extension
Kind	complex-type
Resources that use this resource

StructureDefinition
hl7.fhir.uv.clinical-study-protocol#current	m11-research-study-profile	M11 Research Study Profile
Resources that this resource uses

StructureDefinition
hl7.fhir.uv.clinical-study-protocol#current	m11-amendment-detail	M11_AmendmentDetails
hl7.fhir.uv.clinical-study-protocol#current	m11-amendment-scope-impact	M11_AmendmentScopeImpact
ValueSet
hl7.fhir.uv.clinical-study-protocol#current	m11-amendment-details-statement-vs	ICH M11 Amendment Details Statement Value Set Terminology
hl7.fhir.uv.clinical-study-protocol#current	m11-country-region-vs	ICH M11 Study Amendment Country Value Set
hl7.fhir.uv.clinical-study-protocol#current	m11-study-amendment-reason-vs	ICH M11 Reason for Amendment Value Set Terminology
hl7.fhir.uv.clinical-study-protocol#current	m11-study-amendment-scope-vs	ICH M11 Amendment Scope Value Set Terminology
hl7.fhir.uv.clinical-study-protocol#current	m11-yes-no-vs	ICH M11 No Yes Value Set Terminology
Examples of Use for Extension

Resource	Version
hl7.fhir.uv.clinical-study-protocol#current:ResearchStudy/Exemplar-ResearchStudy-Current-Amendment	R5
Narrative

Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition m11-protocol-amendment
Name	Flags	Card.	Type	Description & Constraints
Extension		0..*	Extension	Amendment to a protocol - from EBM
extension		2..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:identifier		1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"identifier"
value[x]		0..1	Identifier	Amendment identifier
extension:previous		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"previous"
value[x]		0..1	CodeableConcept	Value of extension Binding: ICH M11 Amendment Details Statement Value Set Terminology (required)
extension:scope	S	1..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"scope"
value[x]		0..1	CodeableConcept	Global, Not Global Binding: ICH M11 Amendment Scope Value Set Terminology (extensible)
extension:country		0..*	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"country"
value[x]		0..1	CodeableConcept	Value of extension Binding: ICH M11 Study Amendment Country Value Set (extensible)
extension:region		0..*	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"region"
value[x]		0..1	CodeableConcept	Value of extension Binding: ICH M11 Study Amendment Country Value Set (extensible)
extension:site		0..*	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"site"
value[x]		0..1		Value of extension
valueIdentifier			Identifier
valueReference			Reference(Any)
extension:approvalDate		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"approvalDate"
value[x]		0..1	date	Value of extension
extension:signature		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signature"
value[x]		0..1	Signature	Value of extension
extension:signatureUrl		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureUrl"
value[x]		0..1		Value of extension
valueString			string
valueUrl			url
extension:signatureMethod		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureMethod"
value[x]		0..1	string	Value of extension
extension:scopeImpact	S	0..3	(Complex)	Extension URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact
extension:primaryReason	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"primaryReason"
value[x]		0..1	CodeableConcept	Reason for amendment, e.g. Safety Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
extension:secondaryReason	S	0..*	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"secondaryReason"
value[x]		0..1	CodeableConcept	Reason for amendment, e.g. Manufacturing change Binding: ICH M11 Reason for Amendment Value Set Terminology (extensible)
extension:summary	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"summary"
value[x]		0..1	string	summary of changes
extension:substantialImpactSafety	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"substantialImpactSafety"
value[x]		0..1	CodeableConcept	Substantial impact on safety Binding: ICH M11 No Yes Value Set Terminology (required)
extension:substantialImpactSafetyComment	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"substantialImpactSafetyComment"
value[x]		0..1	string	Comment on substantial impact on safety
extension:substantialImpactReliability		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"substantialImpactReliability"
value[x]		0..1	CodeableConcept	Substantial impact on reliability Binding: ICH M11 No Yes Value Set Terminology (required)
extension:substantialImpactReliabilityComment		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"substantialImpactReliabilityComment"
value[x]		0..1	string	Comment on substantial impact on reliability
extension:details	S	0..*	(Complex)	Extension URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
extension:rationale		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"rationale"
value[x]		0..1	string	Value of extension
extension:description		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"description"
value[x]		0..1		Value of extension
valueMarkdown			markdown
valueString			string
url		1..1	uri	"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment"
value[x]		0..0		Value of extension
Documentation for this format
Source1

{
  "resourceType": "StructureDefinition",
  "id": "m11-protocol-amendment",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
      "valueCode": "can-bind"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 2
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment",
  "version": "1.0.0-ballot2",
  "name": "M11_ProtocolAmendment",
  "status": "active",
  "date": "2026-06-22T17:54:57+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system": "email",
          "value": "UDP@HL7Vulcan.org"
        }
      ]
    }
  ],
  "description": "Amendment to a protocol. This is originally from EBM.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "copyright": "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nCDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
  "fhirVersion": "6.0.0-ballot3",
  "mapping": [
    {
      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
    }
  ],
  "kind": "complex-type",
  "abstract": false,
  "context": [
    {
      "type": "element",
      "expression": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy"
    }
  ],
  "type": "Extension",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
  "derivation": "constraint",
  "snapshot": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
        "valueString": "6.0.0-ballot3"
      }
    ],
    "element": [
      {
        "id": "Extension",
        "path": "Extension",
        "short": "Amendment to a protocol - from EBM",
        "definition": "Representation of amendments to a study protocol.",
        "comment": "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.",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Extension",
          "min": 0,
          "max": "*"
        },
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          },
          {
            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
            "expression": "extension.exists() != value.exists()",
            "source": "http://hl7.org/fhir/StructureDefinition/Extension"
          }
        ],
        "isModifier": false
      },
      {
        "id": "Extension.id",
        "path": "Extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension",
        "path": "Extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 2,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:identifier",
        "path": "Extension.extension",
        "sliceName": "identifier",
        "short": "Extension",
        "definition": "An Extension",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
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        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:identifier.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:identifier.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:identifier.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "identifier",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:identifier.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Amendment identifier",
        "definition": "Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:previous",
        "path": "Extension.extension",
        "sliceName": "previous",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:previous.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:previous.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:previous.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "previous",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:previous.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:scope",
        "path": "Extension.extension",
        "sliceName": "scope",
        "short": "Extension",
        "definition": "An Extension",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:scope.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:scope.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:scope.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "scope",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:scope.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Global, Not Global",
        "definition": "C218673 Global, Country, Region, or Site.",
        "comment": "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n  If amending a single-country study, enter global. \n  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. \n  Use the ISO-3166 region or country identifier (for example, DE or EU).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:country",
        "path": "Extension.extension",
        "sliceName": "country",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:country.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:country.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:country.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "country",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:country.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "C20108",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:region",
        "path": "Extension.extension",
        "sliceName": "region",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:region.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:region.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:region.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "region",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:region.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "C218674",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:site",
        "path": "Extension.extension",
        "sliceName": "site",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:site.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:site.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:site.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "site",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:site.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "C83081",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Identifier"
          },
          {
            "code": "Reference"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:approvalDate",
        "path": "Extension.extension",
        "sliceName": "approvalDate",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:approvalDate.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:approvalDate.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:approvalDate.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "approvalDate",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:approvalDate.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "date"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:signature",
        "path": "Extension.extension",
        "sliceName": "signature",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:signature.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:signature.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:signature.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "signature",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:signature.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Signature"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:signatureUrl",
        "path": "Extension.extension",
        "sliceName": "signatureUrl",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:signatureUrl.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:signatureUrl.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:signatureUrl.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "signatureUrl",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:signatureUrl.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "string"
          },
          {
            "code": "url"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:signatureMethod",
        "path": "Extension.extension",
        "sliceName": "signatureMethod",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:signatureMethod.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:signatureMethod.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:signatureMethod.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "signatureMethod",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:signatureMethod.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "string"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:scopeImpact",
        "path": "Extension.extension",
        "sliceName": "scopeImpact",
        "short": "Extension",
        "definition": "Provides number or percentage of each group affected by a single amendment",
        "min": 0,
        "max": "3",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"
            ]
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:primaryReason",
        "path": "Extension.extension",
        "sliceName": "primaryReason",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:primaryReason.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:primaryReason.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:primaryReason.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "primaryReason",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:primaryReason.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Reason for amendment, e.g. Safety",
        "definition": "Reason for amendment, e.g. Safety.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:secondaryReason",
        "path": "Extension.extension",
        "sliceName": "secondaryReason",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:secondaryReason.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:secondaryReason.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:secondaryReason.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "secondaryReason",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:secondaryReason.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Reason for amendment, e.g. Manufacturing change",
        "definition": "Reason for amendment, e.g. Manufacturing change.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:summary",
        "path": "Extension.extension",
        "sliceName": "summary",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:summary.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:summary.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:summary.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "summary",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:summary.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "summary of changes",
        "definition": "Summary of amendmets.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "string"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactSafety",
        "path": "Extension.extension",
        "sliceName": "substantialImpactSafety",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactSafety.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactSafety.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactSafety.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "substantialImpactSafety",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactSafety.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Substantial impact on safety",
        "definition": "Substantial impact on safety.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactSafetyComment",
        "path": "Extension.extension",
        "sliceName": "substantialImpactSafetyComment",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactSafetyComment.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactSafetyComment.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactSafetyComment.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "substantialImpactSafetyComment",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactSafetyComment.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Comment on substantial impact on safety",
        "definition": "Comment on substantial impact on safety.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "string"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactReliability",
        "path": "Extension.extension",
        "sliceName": "substantialImpactReliability",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactReliability.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactReliability.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactReliability.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "substantialImpactReliability",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactReliability.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Substantial impact on reliability",
        "definition": "Substantial impact on reliability.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactReliabilityComment",
        "path": "Extension.extension",
        "sliceName": "substantialImpactReliabilityComment",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactReliabilityComment.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactReliabilityComment.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:substantialImpactReliabilityComment.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "substantialImpactReliabilityComment",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:substantialImpactReliabilityComment.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Comment on substantial impact on reliability",
        "definition": "Comment on substantial impact on reliability.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "string"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:details",
        "path": "Extension.extension",
        "sliceName": "details",
        "short": "Extension",
        "definition": "Provides detail of a single amendment - repeats within the overal amendment report",
        "min": 0,
        "max": "*",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"
            ]
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:rationale",
        "path": "Extension.extension",
        "sliceName": "rationale",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:rationale.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:rationale.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:rationale.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "rationale",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:rationale.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "string"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:description",
        "path": "Extension.extension",
        "sliceName": "description",
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:description.id",
        "path": "Extension.extension.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.id",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "id"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "condition": [
          "ele-1"
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Extension.extension:description.extension",
        "path": "Extension.extension.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension"
          }
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:description.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "description",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:description.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "markdown"
          },
          {
            "code": "string"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.url",
        "path": "Extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "uri"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.String"
          }
        ],
        "fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment",
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.value[x]",
        "path": "Extension.value[x]",
        "short": "Value of extension",
        "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
        "min": 0,
        "max": "0",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "base64Binary"
          },
          {
            "code": "boolean"
          },
          {
            "code": "canonical"
          },
          {
            "code": "code"
          },
          {
            "code": "date"
          },
          {
            "code": "dateTime"
          },
          {
            "code": "decimal"
          },
          {
            "code": "id"
          },
          {
            "code": "instant"
          },
          {
            "code": "integer"
          },
          {
            "code": "integer64"
          },
          {
            "code": "markdown"
          },
          {
            "code": "oid"
          },
          {
            "code": "positiveInt"
          },
          {
            "code": "string"
          },
          {
            "code": "time"
          },
          {
            "code": "unsignedInt"
          },
          {
            "code": "uri"
          },
          {
            "code": "url"
          },
          {
            "code": "uuid"
          },
          {
            "code": "Address"
          },
          {
            "code": "Age"
          },
          {
            "code": "Annotation"
          },
          {
            "code": "Attachment"
          },
          {
            "code": "CodeableConcept"
          },
          {
            "code": "CodeableReference"
          },
          {
            "code": "Coding"
          },
          {
            "code": "ContactPoint"
          },
          {
            "code": "Count"
          },
          {
            "code": "Distance"
          },
          {
            "code": "Duration"
          },
          {
            "code": "HumanName"
          },
          {
            "code": "Identifier"
          },
          {
            "code": "Money"
          },
          {
            "code": "Period"
          },
          {
            "code": "Quantity"
          },
          {
            "code": "Range"
          },
          {
            "code": "Ratio"
          },
          {
            "code": "RatioRange"
          },
          {
            "code": "Reference"
          },
          {
            "code": "SampledData"
          },
          {
            "code": "Signature"
          },
          {
            "code": "Timing"
          },
          {
            "code": "ContactDetail"
          },
          {
            "code": "DataRequirement"
          },
          {
            "code": "Expression"
          },
          {
            "code": "ParameterDefinition"
          },
          {
            "code": "RelatedArtifact"
          },
          {
            "code": "TriggerDefinition"
          },
          {
            "code": "UsageContext"
          },
          {
            "code": "Availability"
          },
          {
            "code": "ExtendedContactDetail"
          },
          {
            "code": "Dosage"
          },
          {
            "code": "Meta"
          }
        ],
        "condition": [
          "ext-1"
        ],
        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      }
    ]
  },
  "differential": {
    "element": [
      {
        "id": "Extension",
        "path": "Extension",
        "short": "Amendment to a protocol - from EBM",
        "definition": "Representation of amendments to a study protocol.",
        "comment": "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."
      },
      {
        "id": "Extension.extension",
        "path": "Extension.extension",
        "min": 2
      },
      {
        "id": "Extension.extension:identifier",
        "path": "Extension.extension",
        "sliceName": "identifier",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Extension.extension:identifier.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:identifier.url",
        "path": "Extension.extension.url",
        "fixedUri": "identifier"
      },
      {
        "id": "Extension.extension:identifier.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Amendment identifier",
        "definition": "Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page",
        "type": [
          {
            "code": "Identifier"
          }
        ]
      },
      {
        "id": "Extension.extension:previous",
        "path": "Extension.extension",
        "sliceName": "previous",
        "min": 0,
        "max": "1"
      },
      {
        "id": "Extension.extension:previous.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:previous.url",
        "path": "Extension.extension.url",
        "fixedUri": "previous"
      },
      {
        "id": "Extension.extension:previous.value[x]",
        "path": "Extension.extension.value[x]",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"
        }
      },
      {
        "id": "Extension.extension:scope",
        "path": "Extension.extension",
        "sliceName": "scope",
        "min": 1,
        "max": "1",
        "mustSupport": true
      },
      {
        "id": "Extension.extension:scope.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:scope.url",
        "path": "Extension.extension.url",
        "fixedUri": "scope"
      },
      {
        "id": "Extension.extension:scope.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Global, Not Global",
        "definition": "C218673 Global, Country, Region, or Site.",
        "comment": "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n  If amending a single-country study, enter global. \n  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. \n  Use the ISO-3166 region or country identifier (for example, DE or EU).",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs"
        }
      },
      {
        "id": "Extension.extension:country",
        "path": "Extension.extension",
        "sliceName": "country",
        "min": 0,
        "max": "*"
      },
      {
        "id": "Extension.extension:country.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:country.url",
        "path": "Extension.extension.url",
        "fixedUri": "country"
      },
      {
        "id": "Extension.extension:country.value[x]",
        "path": "Extension.extension.value[x]",
        "definition": "C20108",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "strength": "extensible",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"
        }
      },
      {
        "id": "Extension.extension:region",
        "path": "Extension.extension",
        "sliceName": "region",
        "min": 0,
        "max": "*"
      },
      {
        "id": "Extension.extension:region.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:region.url",
        "path": "Extension.extension.url",
        "fixedUri": "region"
      },
      {
        "id": "Extension.extension:region.value[x]",
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