@medplum/definitions 3.2.17 → 3.2.18

package/dist/fhir/r4/profiles-resources.json

@@ -156192,14 +156192,14 @@
         {
           "id" : "EvidenceVariable.characteristic",
           "path" : "EvidenceVariable.characteristic",
-          "short" : "What defines the members of the evidence element",
-          "definition" : "A characteristic that defines the members of the evidence element. Multiple characteristics are applied with \"and\" semantics.",
+          "short" : "A defining factor of the EvidenceVariable",
+          "definition" : "A defining factor of the EvidenceVariable. Multiple characteristics are applied with \"and\" semantics.",
           "comment" : "Characteristics can be defined flexibly to accommodate different use cases for membership criteria, ranging from simple codes, all the way to using an expression language to express the criteria.",
-          "min" : 1,
+          "min" : 0,
           "max" : "*",
           "base" : {
             "path" : "EvidenceVariable.characteristic",
-            "min" : 1,
+            "min" : 0,
             "max" : "*"
           },
           "type" : [{
@@ -156210,9 +156210,16 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
+          },
+          {
+            "key" : "evv-1",
+            "severity" : "error",
+            "human" : "In a characteristic, at most one of these six elements shall be used: definitionReference or definitionCanonical or definitionCodeableConcept or definitionId or definitionByTypeAndValue or definitionByCombination",
+            "expression" : "(definitionReference.count() + definitionCanonical.count() + definitionCodeableConcept.count() + definitionId.count() + definitionByTypeAndValue.count() + definitionByCombination.count())  < 2",
+            "source" : "http://hl7.org/fhir/StructureDefinition/EvidenceVariable"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : true
         },
@@ -156236,6 +156243,7 @@
             }],
             "code" : "http://hl7.org/fhirpath/System.String"
           }],
+          "condition" : ["ele-1"],
           "isModifier" : false,
           "isSummary" : false,
           "mapping" : [{
@@ -156247,7 +156255,7 @@
           "id" : "EvidenceVariable.characteristic.extension",
           "path" : "EvidenceVariable.characteristic.extension",
           "short" : "Additional content defined by implementations",
-          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
           "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
           "alias" : ["extensions",
           "user content"],
@@ -156266,7 +156274,6 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           },
           {
@@ -156274,7 +156281,6 @@
             "severity" : "error",
             "human" : "Must have either extensions or value[x], not both",
             "expression" : "extension.exists() != value.exists()",
-            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
             "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
           }],
           "isModifier" : false,
@@ -156288,7 +156294,7 @@
           "id" : "EvidenceVariable.characteristic.modifierExtension",
           "path" : "EvidenceVariable.characteristic.modifierExtension",
           "short" : "Extensions that cannot be ignored even if unrecognized",
-          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
           "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
           "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
           "alias" : ["extensions",
@@ -156309,7 +156315,6 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           },
           {
@@ -156317,7 +156322,6 @@
             "severity" : "error",
             "human" : "Must have either extensions or value[x], not both",
             "expression" : "extension.exists() != value.exists()",
-            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
             "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
           }],
           "isModifier" : true,
@@ -156328,6 +156332,32 @@
             "map" : "N/A"
           }]
         },
+        {
+          "id" : "EvidenceVariable.characteristic.linkId",
+          "path" : "EvidenceVariable.characteristic.linkId",
+          "short" : "Label for internal linking",
+          "definition" : "Label used for when a characteristic refers to another characteristic.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.linkId",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "id"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
         {
           "id" : "EvidenceVariable.characteristic.description",
           "path" : "EvidenceVariable.characteristic.description",
@@ -156342,212 +156372,1079 @@
             "max" : "1"
           },
           "type" : [{
-            "code" : "string"
+            "code" : "markdown"
           }],
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false
         },
         {
-          "id" : "EvidenceVariable.characteristic.definition[x]",
-          "path" : "EvidenceVariable.characteristic.definition[x]",
-          "short" : "What code or expression defines members?",
-          "definition" : "Define members of the evidence element using Codes (such as condition, medication, or observation), Expressions ( using an expression language such as FHIRPath or CQL) or DataRequirements (such as Diabetes diagnosis onset in the last year).",
-          "requirements" : "Need to be able to define members in simple codes when the membership aligns well with terminology, with common criteria such as observations in a value set or lab tests within a year, or with expression language to support criteria that do not fit in the above.",
+          "id" : "EvidenceVariable.characteristic.note",
+          "path" : "EvidenceVariable.characteristic.note",
+          "short" : "Used for footnotes or explanatory notes",
+          "definition" : "A human-readable string to clarify or explain concepts about the characteristic.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.note",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "Annotation"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.exclude",
+          "path" : "EvidenceVariable.characteristic.exclude",
+          "short" : "Whether the characteristic is an inclusion criterion or exclusion criterion",
+          "definition" : "When true, this characteristic is an exclusion criterion. In other words, not matching this characteristic definition is equivalent to meeting this criterion.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.exclude",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "boolean"
+          }],
+          "meaningWhenMissing" : "False",
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionReference",
+          "path" : "EvidenceVariable.characteristic.definitionReference",
+          "short" : "Defines the characteristic (without using type and value) by a Reference",
+          "definition" : "Defines the characteristic using a Reference.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionReference",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable",
+            "http://hl7.org/fhir/StructureDefinition/Group",
+            "http://hl7.org/fhir/StructureDefinition/Evidence"]
+          }],
+          "condition" : ["evv-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"
+          }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : true
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionCanonical",
+          "path" : "EvidenceVariable.characteristic.definitionCanonical",
+          "short" : "Defines the characteristic (without using type and value) by a Canonical",
+          "definition" : "Defines the characteristic using Canonical.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionCanonical",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "canonical",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable",
+            "http://hl7.org/fhir/StructureDefinition/Evidence"]
+          }],
+          "condition" : ["evv-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"
+          }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : true
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionCodeableConcept",
+          "path" : "EvidenceVariable.characteristic.definitionCodeableConcept",
+          "short" : "Defines the characteristic (without using type and value) by a CodeableConcept",
+          "definition" : "Defines the characteristic using CodeableConcept.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionCodeableConcept",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "condition" : ["evv-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"
+          }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : true
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionExpression",
+          "path" : "EvidenceVariable.characteristic.definitionExpression",
+          "short" : "Defines the characteristic (without using type and value) by an expression",
+          "definition" : "Defines the characteristic using Expression.",
+          "comment" : "When another element provides a definition of the characteristic, the definitionExpression content SHALL match the definition (only adding technical concepts necessary for implementation) without changing the meaning.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionExpression",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Expression"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionId",
+          "path" : "EvidenceVariable.characteristic.definitionId",
+          "short" : "Defines the characteristic (without using type and value) by an id",
+          "definition" : "Defines the characteristic using id.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionId",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "id"
+          }],
+          "condition" : ["evv-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"
+          }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : true
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue",
+          "short" : "Defines the characteristic using type and value",
+          "definition" : "Defines the characteristic using both a type and value[x] elements.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "condition" : ["evv-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"
+          }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : true
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.id",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.extension",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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"
+          },
+          {
+            "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.modifierExtension",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.type",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.type",
+          "short" : "Expresses the type of characteristic",
+          "definition" : "Used to express the type of characteristic.",
           "min" : 1,
           "max" : "1",
           "base" : {
-            "path" : "EvidenceVariable.characteristic.definition[x]",
+            "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.type",
             "min" : 1,
             "max" : "1"
           },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "UsageContextType"
+            }],
+            "strength" : "example",
+            "valueSet" : "http://terminology.hl7.org/ValueSet/usage-context-type"
+          }
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.method",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.method",
+          "short" : "Method for how the characteristic value was determined",
+          "definition" : "Method for how the characteristic value was determined.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.method",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "DefinitionMethod"
+            }],
+            "strength" : "example",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/definition-method"
+          }
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.device",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.device",
+          "short" : "Device used for determining characteristic",
+          "definition" : "Device used for determining characteristic.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.device",
+            "min" : 0,
+            "max" : "1"
+          },
           "type" : [{
             "code" : "Reference",
-            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Device",
+            "http://hl7.org/fhir/StructureDefinition/DeviceMetric"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.value[x]",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.value[x]",
+          "short" : "Defines the characteristic when coupled with characteristic.type",
+          "definition" : "Defines the characteristic when paired with characteristic.type.",
+          "min" : 1,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.value[x]",
+            "min" : 1,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
           },
           {
-            "code" : "canonical",
-            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ActivityDefinition"]
+            "code" : "boolean"
           },
           {
-            "code" : "CodeableConcept"
+            "code" : "Quantity"
           },
           {
-            "code" : "Expression"
+            "code" : "Range"
           },
           {
-            "code" : "DataRequirement"
+            "code" : "Reference"
           },
           {
-            "code" : "TriggerDefinition"
+            "code" : "id"
           }],
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : true
         },
         {
-          "id" : "EvidenceVariable.characteristic.usageContext",
-          "path" : "EvidenceVariable.characteristic.usageContext",
-          "short" : "What code/value pairs define members?",
-          "definition" : "Use UsageContext to define the members of the population, such as Age Ranges, Genders, Settings.",
-          "requirements" : "Need to be able to define members more structurally when more information can be communicated such as age range.",
+          "id" : "EvidenceVariable.characteristic.definitionByTypeAndValue.offset",
+          "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.offset",
+          "short" : "Reference point for valueQuantity or valueRange",
+          "definition" : "Defines the reference point for comparison when valueQuantity or valueRange is not compared to zero.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByTypeAndValue.offset",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "CharacteristicOffset"
+            }],
+            "strength" : "example",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/characteristic-offset"
+          }
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByCombination",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination",
+          "short" : "Used to specify how two or more characteristics are combined",
+          "definition" : "Defines the characteristic as a combination of two or more characteristics.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByCombination",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "condition" : ["evv-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"
+          }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByCombination.id",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByCombination.extension",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
           "min" : 0,
           "max" : "*",
           "base" : {
-            "path" : "EvidenceVariable.characteristic.usageContext",
+            "path" : "Element.extension",
             "min" : 0,
             "max" : "*"
           },
           "type" : [{
-            "code" : "UsageContext"
+            "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())",
-            "xpath" : "@value|f:*|h:div",
             "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,
-          "isSummary" : false
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
         },
         {
-          "id" : "EvidenceVariable.characteristic.exclude",
-          "path" : "EvidenceVariable.characteristic.exclude",
-          "short" : "Whether the characteristic includes or excludes members",
-          "definition" : "When true, members with this characteristic are excluded from the element.",
+          "id" : "EvidenceVariable.characteristic.definitionByCombination.modifierExtension",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByCombination.code",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination.code",
+          "short" : "all-of | any-of | at-least | at-most | statistical | net-effect | dataset",
+          "definition" : "Used to specify if two or more characteristics are combined with OR or AND.",
+          "requirements" : "If code is \"at-least\" or \"at-most\" then threshold SHALL be used. If code is neither \"at-least\" nor \"at-most\" then threshold SHALL NOT be used.",
+          "min" : 1,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByCombination.code",
+            "min" : 1,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "code"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "CharacteristicCombination"
+            }],
+            "strength" : "required",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/characteristic-combination|5.0.0"
+          }
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.definitionByCombination.threshold",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination.threshold",
+          "short" : "Provides the value of \"n\" when \"at-least\" or \"at-most\" codes are used",
+          "definition" : "Provides the value of \"n\" when \"at-least\" or \"at-most\" codes are used.",
           "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "EvidenceVariable.characteristic.exclude",
+            "path" : "EvidenceVariable.characteristic.definitionByCombination.threshold",
             "min" : 0,
             "max" : "1"
           },
           "type" : [{
-            "code" : "boolean"
+            "code" : "positiveInt"
           }],
-          "meaningWhenMissing" : "False",
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false
         },
         {
-          "id" : "EvidenceVariable.characteristic.participantEffective[x]",
-          "path" : "EvidenceVariable.characteristic.participantEffective[x]",
-          "short" : "What time period do participants cover",
-          "definition" : "Indicates what effective period the study covers.",
+          "id" : "EvidenceVariable.characteristic.definitionByCombination.characteristic",
+          "path" : "EvidenceVariable.characteristic.definitionByCombination.characteristic",
+          "short" : "A defining factor of the characteristic",
+          "definition" : "A defining factor of the characteristic.",
+          "min" : 1,
+          "max" : "*",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.definitionByCombination.characteristic",
+            "min" : 1,
+            "max" : "*"
+          },
+          "contentReference" : "#EvidenceVariable.characteristic",
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.instances[x]",
+          "path" : "EvidenceVariable.characteristic.instances[x]",
+          "short" : "Number of occurrences meeting the characteristic",
+          "definition" : "Number of occurrences meeting the characteristic.",
           "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "EvidenceVariable.characteristic.participantEffective[x]",
+            "path" : "EvidenceVariable.characteristic.instances[x]",
             "min" : 0,
             "max" : "1"
           },
           "type" : [{
-            "code" : "dateTime"
+            "code" : "Quantity"
           },
           {
-            "code" : "Period"
+            "code" : "Range"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.duration[x]",
+          "path" : "EvidenceVariable.characteristic.duration[x]",
+          "short" : "Length of time in which the characteristic is met",
+          "definition" : "Length of time in which the characteristic is met.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.duration[x]",
+            "min" : 0,
+            "max" : "1"
           },
-          {
-            "code" : "Duration"
+          "type" : [{
+            "code" : "Quantity"
           },
           {
-            "code" : "Timing"
+            "code" : "Range"
           }],
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false
         },
         {
-          "id" : "EvidenceVariable.characteristic.timeFromStart",
-          "path" : "EvidenceVariable.characteristic.timeFromStart",
-          "short" : "Observation time from study start",
-          "definition" : "Indicates duration from the participant's study entry.",
+          "id" : "EvidenceVariable.characteristic.timeFromEvent",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent",
+          "short" : "Timing in which the characteristic is determined",
+          "definition" : "Timing in which the characteristic is determined.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.timeFromEvent",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.id",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.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" : "EvidenceVariable.characteristic.timeFromStart",
+            "path" : "Element.id",
             "min" : 0,
             "max" : "1"
           },
           "type" : [{
-            "code" : "Duration"
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
+              "valueUrl" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.extension",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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())",
-            "xpath" : "@value|f:*|h:div",
             "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.modifierExtension",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.description",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.description",
+          "short" : "Human readable description",
+          "definition" : "Human readable description.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.timeFromEvent.description",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "markdown"
+          }],
+          "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" : false,
+          "isModifier" : false,
           "isSummary" : false
         },
         {
-          "id" : "EvidenceVariable.characteristic.groupMeasure",
-          "path" : "EvidenceVariable.characteristic.groupMeasure",
-          "short" : "mean | median | mean-of-mean | mean-of-median | median-of-mean | median-of-median",
-          "definition" : "Indicates how elements are aggregated within the study effective period.",
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.note",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.note",
+          "short" : "Used for footnotes or explanatory notes",
+          "definition" : "A human-readable string to clarify or explain concepts about the timeFromEvent.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.timeFromEvent.note",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "Annotation"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.event[x]",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.event[x]",
+          "short" : "The event used as a base point (reference point) in time",
+          "definition" : "The event used as a base point (reference point) in time.",
           "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "EvidenceVariable.characteristic.groupMeasure",
+            "path" : "EvidenceVariable.characteristic.timeFromEvent.event[x]",
             "min" : 0,
             "max" : "1"
           },
           "type" : [{
-            "code" : "code"
+            "code" : "CodeableConcept"
+          },
+          {
+            "code" : "Reference"
+          },
+          {
+            "code" : "dateTime"
+          },
+          {
+            "code" : "id"
           }],
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false,
           "binding" : {
             "extension" : [{
               "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
-              "valueString" : "GroupMeasure"
+              "valueString" : "EvidenceVariableEvent"
             }],
-            "strength" : "required",
-            "description" : "Possible group measure aggregates (E.g. Mean, Median).",
-            "valueSet" : "http://hl7.org/fhir/ValueSet/group-measure|4.0.1"
+            "strength" : "example",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/evidence-variable-event"
           }
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.quantity",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.quantity",
+          "short" : "Used to express the observation at a defined amount of time before or after the event",
+          "definition" : "Used to express the observation at a defined amount of time before or after the event.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.timeFromEvent.quantity",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Quantity"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "EvidenceVariable.characteristic.timeFromEvent.range",
+          "path" : "EvidenceVariable.characteristic.timeFromEvent.range",
+          "short" : "Used to express the observation within a period before and/or after the event",
+          "definition" : "Used to express the observation within a period before and/or after the event.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "EvidenceVariable.characteristic.timeFromEvent.range",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Range"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
         }]
       },
       "differential" : {
@@ -312662,11 +313559,37 @@
             "map" : ".identifier"
           }]
         },
+        {
+          "id" : "ResearchStudy.name",
+          "path" : "ResearchStudy.name",
+          "short" : "Name for this study (computer friendly)",
+          "definition" : "Name for this study (computer friendly).",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.name",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "string"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
         {
           "id" : "ResearchStudy.title",
           "path" : "ResearchStudy.title",
-          "short" : "Name for this study",
-          "definition" : "A short, descriptive user-friendly label for the study.",
+          "short" : "Human readable name of the study",
+          "definition" : "The human readable name of the research study.",
           "min" : 0,
           "max" : "1",
           "base" : {
@@ -312682,9 +313605,9 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : true,
           "mapping" : [{
@@ -312696,6 +313619,202 @@
             "map" : "No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
           }]
         },
+        {
+          "id" : "ResearchStudy.label",
+          "path" : "ResearchStudy.label",
+          "short" : "Additional names for the study",
+          "definition" : "Additional names for the study.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.label",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.label.id",
+          "path" : "ResearchStudy.label.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.label.extension",
+          "path" : "ResearchStudy.label.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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"
+          },
+          {
+            "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.label.modifierExtension",
+          "path" : "ResearchStudy.label.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.label.type",
+          "path" : "ResearchStudy.label.type",
+          "short" : "primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid",
+          "definition" : "Kind of name.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.label.type",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "TitleType"
+            }],
+            "strength" : "extensible",
+            "description" : "desc.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/title-type"
+          }
+        },
+        {
+          "id" : "ResearchStudy.label.value",
+          "path" : "ResearchStudy.label.value",
+          "short" : "The name",
+          "definition" : "The name.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.label.value",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "string"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
         {
           "id" : "ResearchStudy.protocol",
           "path" : "ResearchStudy.protocol",
@@ -312879,9 +313998,9 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : true,
           "binding" : {
@@ -312902,6 +314021,49 @@
             "map" : "StudyProtocolVersion.phaseCode"
           }]
         },
+        {
+          "id" : "ResearchStudy.studyDesign",
+          "path" : "ResearchStudy.studyDesign",
+          "short" : "Classifications of the study design characteristics",
+          "definition" : "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.studyDesign",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "StudyDesign"
+            }],
+            "strength" : "preferred",
+            "description" : "This is a set of terms for study design characteristics.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/study-design"
+          },
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
+          }]
+        },
         {
           "id" : "ResearchStudy.category",
           "path" : "ResearchStudy.category",
@@ -313074,8 +314236,8 @@
         {
           "id" : "ResearchStudy.relatedArtifact",
           "path" : "ResearchStudy.relatedArtifact",
-          "short" : "References and dependencies",
-          "definition" : "Citations, references and other related documents.",
+          "short" : "References, URLs, and attachments",
+          "definition" : "Citations, references, URLs and other related documents.  When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of \"documentation\" or \"supported-with\" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.",
           "min" : 0,
           "max" : "*",
           "base" : {
@@ -313091,9 +314253,9 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false,
           "mapping" : [{
@@ -313190,11 +314352,80 @@
             "map" : "StudyProtocolVersion.participatingLocationCode"
           }]
         },
+        {
+          "id" : "ResearchStudy.region",
+          "path" : "ResearchStudy.region",
+          "short" : "Geographic area for the study",
+          "definition" : "A country, state or other area where the study is taking place rather than its precise geographic location or address.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.region",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "Jurisdiction"
+            },
+            {
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
+              "valueBoolean" : true
+            }],
+            "strength" : "extensible",
+            "description" : "Countries and regions within which this artifact is targeted for use.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
+          },
+          "mapping" : [{
+            "identity" : "BRIDG5.1",
+            "map" : "StudyProtocolVersion.participatingLocationCode"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.descriptionSummary",
+          "path" : "ResearchStudy.descriptionSummary",
+          "short" : "Brief text explaining the study",
+          "definition" : "A brief text for explaining the study.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.descriptionSummary",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "markdown"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
         {
           "id" : "ResearchStudy.description",
           "path" : "ResearchStudy.description",
-          "short" : "What this is study doing",
-          "definition" : "A full description of how the study is being conducted.",
+          "short" : "Detailed narrative of the study",
+          "definition" : "A detailed and human-readable narrative of the study. E.g., study abstract.",
           "min" : 0,
           "max" : "1",
           "base" : {
@@ -313210,9 +314441,9 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false,
           "mapping" : [{
@@ -313413,16 +314644,18 @@
           },
           "type" : [{
             "code" : "Reference",
-            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Location"]
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Location",
+            "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
+            "http://hl7.org/fhir/StructureDefinition/Organization"]
           }],
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : true,
           "mapping" : [{
@@ -313581,10 +314814,1461 @@
           }]
         },
         {
-          "id" : "ResearchStudy.arm.extension",
-          "path" : "ResearchStudy.arm.extension",
+          "id" : "ResearchStudy.arm.extension",
+          "path" : "ResearchStudy.arm.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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())",
+            "xpath" : "@value|f:*|h:div",
+            "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()",
+            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
+            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
+          }],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.arm.modifierExtension",
+          "path" : "ResearchStudy.arm.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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())",
+            "xpath" : "@value|f:*|h:div",
+            "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()",
+            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
+            "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
+          }],
+          "isModifier" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.arm.name",
+          "path" : "ResearchStudy.arm.name",
+          "short" : "Label for study arm",
+          "definition" : "Unique, human-readable label for this arm of the study.",
+          "min" : 1,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.arm.name",
+            "min" : 1,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "string"
+          }],
+          "constraint" : [{
+            "key" : "ele-1",
+            "severity" : "error",
+            "human" : "All FHIR elements must have a @value or children",
+            "expression" : "hasValue() or (children().count() > id.count())",
+            "xpath" : "@value|f:*|h:div",
+            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
+          }],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arm Label"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm.name"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.arm.type",
+          "path" : "ResearchStudy.arm.type",
+          "short" : "Categorization of study arm",
+          "definition" : "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.arm.type",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "constraint" : [{
+            "key" : "ele-1",
+            "severity" : "error",
+            "human" : "All FHIR elements must have a @value or children",
+            "expression" : "hasValue() or (children().count() > id.count())",
+            "xpath" : "@value|f:*|h:div",
+            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
+          }],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arm Type"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm.typeCode"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.arm.description",
+          "path" : "ResearchStudy.arm.description",
+          "short" : "Short explanation of study path",
+          "definition" : "A succinct description of the path through the study that would be followed by a subject adhering to this arm.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.arm.description",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "string"
+          }],
+          "constraint" : [{
+            "key" : "ele-1",
+            "severity" : "error",
+            "human" : "All FHIR elements must have a @value or children",
+            "expression" : "hasValue() or (children().count() > id.count())",
+            "xpath" : "@value|f:*|h:div",
+            "source" : "http://hl7.org/fhir/StructureDefinition/Element"
+          }],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arm Description"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm.description"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.classifier",
+          "path" : "ResearchStudy.classifier",
+          "short" : "Classification for the study",
+          "definition" : "Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.classifier",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyClassifiers"
+            }],
+            "strength" : "example",
+            "description" : "desc.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-classifiers"
+          }
+        },
+        {
+          "id" : "ResearchStudy.associatedParty",
+          "path" : "ResearchStudy.associatedParty",
+          "short" : "Sponsors, collaborators, and other parties",
+          "definition" : "Sponsors, collaborators, and other parties.",
+          "comment" : "For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.",
+          "requirements" : "While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.associatedParty",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.id",
+          "path" : "ResearchStudy.associatedParty.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.extension",
+          "path" : "ResearchStudy.associatedParty.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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"
+          },
+          {
+            "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.modifierExtension",
+          "path" : "ResearchStudy.associatedParty.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.name",
+          "path" : "ResearchStudy.associatedParty.name",
+          "short" : "Name of associated party",
+          "definition" : "Name of associated party.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.associatedParty.name",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "string"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.role",
+          "path" : "ResearchStudy.associatedParty.role",
+          "short" : "sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair",
+          "definition" : "Type of association.",
+          "min" : 1,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.associatedParty.role",
+            "min" : 1,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyPartyRole"
+            }],
+            "strength" : "extensible",
+            "description" : "desc.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-party-role"
+          }
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.period",
+          "path" : "ResearchStudy.associatedParty.period",
+          "short" : "When active in the role",
+          "definition" : "Identifies the start date and the end date of the associated party in the role.",
+          "comment" : "The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.associatedParty.period",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "Period"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.classifier",
+          "path" : "ResearchStudy.associatedParty.classifier",
+          "short" : "nih | fda | government | nonprofit | academic | industry",
+          "definition" : "A categorization other than role for the associated party.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.associatedParty.classifier",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyPartyOrganizationType"
+            }],
+            "strength" : "example",
+            "description" : "A characterization or type of the entity.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-party-organization-type"
+          }
+        },
+        {
+          "id" : "ResearchStudy.associatedParty.party",
+          "path" : "ResearchStudy.associatedParty.party",
+          "short" : "Individual or organization associated with study (use practitionerRole to specify their organisation)",
+          "definition" : "Individual or organization associated with study (use practitionerRole to specify their organisation).",
+          "comment" : "Suggestions of a better attribute name are appreciated",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.associatedParty.party",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Practitioner",
+            "http://hl7.org/fhir/StructureDefinition/PractitionerRole",
+            "http://hl7.org/fhir/StructureDefinition/Organization"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.progressStatus",
+          "path" : "ResearchStudy.progressStatus",
+          "short" : "Status of study with time for that status",
+          "definition" : "Status of study with time for that status.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.progressStatus",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.progressStatus.id",
+          "path" : "ResearchStudy.progressStatus.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.progressStatus.extension",
+          "path" : "ResearchStudy.progressStatus.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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"
+          },
+          {
+            "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.progressStatus.modifierExtension",
+          "path" : "ResearchStudy.progressStatus.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.progressStatus.state",
+          "path" : "ResearchStudy.progressStatus.state",
+          "short" : "Label for status or state (e.g. recruitment status)",
+          "definition" : "Label for status or state (e.g. recruitment status).",
+          "min" : 1,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.progressStatus.state",
+            "min" : 1,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyStudyStatus"
+            }],
+            "strength" : "extensible",
+            "description" : "defn.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-status"
+          }
+        },
+        {
+          "id" : "ResearchStudy.progressStatus.actual",
+          "path" : "ResearchStudy.progressStatus.actual",
+          "short" : "Actual if true else anticipated",
+          "definition" : "An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.progressStatus.actual",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "boolean"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.progressStatus.period",
+          "path" : "ResearchStudy.progressStatus.period",
+          "short" : "Date range",
+          "definition" : "Date range.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.progressStatus.period",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Period"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.whyStopped",
+          "path" : "ResearchStudy.whyStopped",
+          "short" : "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
+          "definition" : "A description and/or code explaining the premature termination of the study.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.whyStopped",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyReasonStopped"
+            }],
+            "strength" : "example",
+            "description" : "Codes for why the study ended prematurely.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-reason-stopped"
+          },
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Why Study Stopped"
+          },
+          {
+            "identity" : "w5",
+            "map" : "FiveWs.why[x]"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "StudyOverallStatus.studyStoppedReasonCode"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.recruitment",
+          "path" : "ResearchStudy.recruitment",
+          "short" : "Target or actual group of participants enrolled in study",
+          "definition" : "Target or actual group of participants enrolled in study.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.recruitment",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
+          },
+          {
+            "identity" : "w5",
+            "map" : "FiveWs.subject[x]"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "InterventionalStudyProtocol.interventionGroupQuantity"
+          },
+          {
+            "identity" : "rim",
+            "map" : ".participation[typeCode=SBJ].role"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.recruitment.id",
+          "path" : "ResearchStudy.recruitment.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.recruitment.extension",
+          "path" : "ResearchStudy.recruitment.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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"
+          },
+          {
+            "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.recruitment.modifierExtension",
+          "path" : "ResearchStudy.recruitment.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.recruitment.targetNumber",
+          "path" : "ResearchStudy.recruitment.targetNumber",
+          "short" : "Estimated total number of participants to be enrolled",
+          "definition" : "Estimated total number of participants to be enrolled.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.recruitment.targetNumber",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "unsignedInt"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.recruitment.actualNumber",
+          "path" : "ResearchStudy.recruitment.actualNumber",
+          "short" : "Actual total number of participants enrolled in study",
+          "definition" : "Actual total number of participants enrolled in study.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.recruitment.actualNumber",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "unsignedInt"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.recruitment.eligibility",
+          "path" : "ResearchStudy.recruitment.eligibility",
+          "short" : "Inclusion and exclusion criteria",
+          "definition" : "Inclusion and exclusion criteria.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.recruitment.eligibility",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group",
+            "http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.recruitment.actualGroup",
+          "path" : "ResearchStudy.recruitment.actualGroup",
+          "short" : "Group of participants who were enrolled in study",
+          "definition" : "Group of participants who were enrolled in study.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.recruitment.actualGroup",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
+          },
+          {
+            "identity" : "w5",
+            "map" : "FiveWs.subject[x]"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "InterventionalStudyProtocol.interventionGroupQuantity"
+          },
+          {
+            "identity" : "rim",
+            "map" : ".participation[typeCode=SBJ].role"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup",
+          "path" : "ResearchStudy.comparisonGroup",
+          "short" : "Defined path through the study for a subject",
+          "definition" : "Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.",
+          "comment" : "In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.",
+          "alias" : ["arm"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arms"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.id",
+          "path" : "ResearchStudy.comparisonGroup.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.extension",
+          "path" : "ResearchStudy.comparisonGroup.extension",
+          "short" : "Additional content defined by implementations",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "alias" : ["extensions",
+          "user content"],
+          "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"
+          },
+          {
+            "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,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.modifierExtension",
+          "path" : "ResearchStudy.comparisonGroup.modifierExtension",
+          "short" : "Extensions that cannot be ignored even if unrecognized",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
+          "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
+          "alias" : ["extensions",
+          "user content",
+          "modifiers"],
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "BackboneElement.modifierExtension",
+            "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"
+          },
+          {
+            "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" : true,
+          "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
+          "isSummary" : true,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "N/A"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.linkId",
+          "path" : "ResearchStudy.comparisonGroup.linkId",
+          "short" : "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily",
+          "definition" : "Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup.linkId",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "id"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.name",
+          "path" : "ResearchStudy.comparisonGroup.name",
+          "short" : "Label for study comparisonGroup",
+          "definition" : "Unique, human-readable label for this comparisonGroup of the study.",
+          "min" : 1,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup.name",
+            "min" : 1,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "string"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arm Label"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm.name"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.type",
+          "path" : "ResearchStudy.comparisonGroup.type",
+          "short" : "Categorization of study comparisonGroup",
+          "definition" : "Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup.type",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyArmType"
+            }],
+            "strength" : "extensible",
+            "description" : "desc.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-arm-type"
+          },
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arm Type"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm.typeCode"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.description",
+          "path" : "ResearchStudy.comparisonGroup.description",
+          "short" : "Short explanation of study path",
+          "definition" : "A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup.description",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "markdown"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Arm Description"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "Arm.description"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.intendedExposure",
+          "path" : "ResearchStudy.comparisonGroup.intendedExposure",
+          "short" : "Interventions or exposures in this comparisonGroup or cohort",
+          "definition" : "Interventions or exposures in this comparisonGroup or cohort.",
+          "requirements" : "this is necessary for ClinicalTrials.gov use which relates  1 to many interventions to comparisonGroups (aka arms)",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup.intendedExposure",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.comparisonGroup.observedGroup",
+          "path" : "ResearchStudy.comparisonGroup.observedGroup",
+          "short" : "Group of participants who were enrolled in study comparisonGroup",
+          "definition" : "Group of participants who were enrolled in study comparisonGroup.",
+          "requirements" : "This is necessary to relate comparisonGroups to actual groups",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.comparisonGroup.observedGroup",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Group"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.objective",
+          "path" : "ResearchStudy.objective",
+          "short" : "A goal for the study",
+          "definition" : "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.objective",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "BackboneElement"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "BRIDG5.1",
+            "map" : "StudyObjective"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.objective.id",
+          "path" : "ResearchStudy.objective.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" : "string"
+            }],
+            "code" : "http://hl7.org/fhirpath/System.String"
+          }],
+          "condition" : ["ele-1"],
+          "isModifier" : false,
+          "isSummary" : false,
+          "mapping" : [{
+            "identity" : "rim",
+            "map" : "n/a"
+          }]
+        },
+        {
+          "id" : "ResearchStudy.objective.extension",
+          "path" : "ResearchStudy.objective.extension",
           "short" : "Additional content defined by implementations",
-          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
           "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
           "alias" : ["extensions",
           "user content"],
@@ -313603,7 +316287,6 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           },
           {
@@ -313611,7 +316294,6 @@
             "severity" : "error",
             "human" : "Must have either extensions or value[x], not both",
             "expression" : "extension.exists() != value.exists()",
-            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
             "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
           }],
           "isModifier" : false,
@@ -313622,10 +316304,10 @@
           }]
         },
         {
-          "id" : "ResearchStudy.arm.modifierExtension",
-          "path" : "ResearchStudy.arm.modifierExtension",
+          "id" : "ResearchStudy.objective.modifierExtension",
+          "path" : "ResearchStudy.objective.modifierExtension",
           "short" : "Extensions that cannot be ignored even if unrecognized",
-          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
           "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
           "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
           "alias" : ["extensions",
@@ -313646,7 +316328,6 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           },
           {
@@ -313654,7 +316335,6 @@
             "severity" : "error",
             "human" : "Must have either extensions or value[x], not both",
             "expression" : "extension.exists() != value.exists()",
-            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
             "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
           }],
           "isModifier" : true,
@@ -313666,15 +316346,15 @@
           }]
         },
         {
-          "id" : "ResearchStudy.arm.name",
-          "path" : "ResearchStudy.arm.name",
-          "short" : "Label for study arm",
-          "definition" : "Unique, human-readable label for this arm of the study.",
-          "min" : 1,
+          "id" : "ResearchStudy.objective.name",
+          "path" : "ResearchStudy.objective.name",
+          "short" : "Label for the objective",
+          "definition" : "Unique, human-readable label for this objective of the study.",
+          "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "ResearchStudy.arm.name",
-            "min" : 1,
+            "path" : "ResearchStudy.objective.name",
+            "min" : 0,
             "max" : "1"
           },
           "type" : [{
@@ -313685,29 +316365,25 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false,
           "mapping" : [{
-            "identity" : "clinicaltrials-gov",
-            "map" : "Arm Label"
-          },
-          {
             "identity" : "BRIDG5.1",
-            "map" : "Arm.name"
+            "map" : "No BRIDG mapping (BRIDG has a description, but not a name)"
           }]
         },
         {
-          "id" : "ResearchStudy.arm.type",
-          "path" : "ResearchStudy.arm.type",
-          "short" : "Categorization of study arm",
-          "definition" : "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
+          "id" : "ResearchStudy.objective.type",
+          "path" : "ResearchStudy.objective.type",
+          "short" : "primary | secondary | exploratory",
+          "definition" : "The kind of study objective.",
           "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "ResearchStudy.arm.type",
+            "path" : "ResearchStudy.objective.type",
             "min" : 0,
             "max" : "1"
           },
@@ -313719,63 +316395,61 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false,
-          "mapping" : [{
-            "identity" : "clinicaltrials-gov",
-            "map" : "Arm Type"
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "ResearchStudyObjectiveType"
+            }],
+            "strength" : "preferred",
+            "description" : "Codes for the kind of study objective.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
           },
-          {
+          "mapping" : [{
             "identity" : "BRIDG5.1",
-            "map" : "Arm.typeCode"
+            "map" : "StudyObjective.typeCode"
           }]
         },
         {
-          "id" : "ResearchStudy.arm.description",
-          "path" : "ResearchStudy.arm.description",
-          "short" : "Short explanation of study path",
-          "definition" : "A succinct description of the path through the study that would be followed by a subject adhering to this arm.",
+          "id" : "ResearchStudy.objective.description",
+          "path" : "ResearchStudy.objective.description",
+          "short" : "Description of the objective",
+          "definition" : "Free text description of the objective of the study.  This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).",
           "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "ResearchStudy.arm.description",
+            "path" : "ResearchStudy.objective.description",
             "min" : 0,
             "max" : "1"
           },
           "type" : [{
-            "code" : "string"
+            "code" : "markdown"
           }],
           "constraint" : [{
             "key" : "ele-1",
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
-          "isSummary" : false,
-          "mapping" : [{
-            "identity" : "clinicaltrials-gov",
-            "map" : "Arm Description"
-          },
-          {
-            "identity" : "BRIDG5.1",
-            "map" : "Arm.description"
-          }]
+          "isSummary" : false
         },
         {
-          "id" : "ResearchStudy.objective",
-          "path" : "ResearchStudy.objective",
-          "short" : "A goal for the study",
-          "definition" : "A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.",
+          "id" : "ResearchStudy.outcomeMeasure",
+          "path" : "ResearchStudy.outcomeMeasure",
+          "short" : "A variable measured during the study",
+          "definition" : "An \"outcome measure\", \"endpoint\", \"effect measure\" or \"measure of effect\" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.",
+          "comment" : "A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP",
           "min" : 0,
           "max" : "*",
           "base" : {
-            "path" : "ResearchStudy.objective",
+            "path" : "ResearchStudy.outcomeMeasure",
             "min" : 0,
             "max" : "*"
           },
@@ -313787,19 +316461,15 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
-          "isSummary" : false,
-          "mapping" : [{
-            "identity" : "BRIDG5.1",
-            "map" : "StudyObjective"
-          }]
+          "isSummary" : false
         },
         {
-          "id" : "ResearchStudy.objective.id",
-          "path" : "ResearchStudy.objective.id",
+          "id" : "ResearchStudy.outcomeMeasure.id",
+          "path" : "ResearchStudy.outcomeMeasure.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.",
@@ -313817,6 +316487,7 @@
             }],
             "code" : "http://hl7.org/fhirpath/System.String"
           }],
+          "condition" : ["ele-1"],
           "isModifier" : false,
           "isSummary" : false,
           "mapping" : [{
@@ -313825,10 +316496,10 @@
           }]
         },
         {
-          "id" : "ResearchStudy.objective.extension",
-          "path" : "ResearchStudy.objective.extension",
+          "id" : "ResearchStudy.outcomeMeasure.extension",
+          "path" : "ResearchStudy.outcomeMeasure.extension",
           "short" : "Additional content defined by implementations",
-          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
           "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
           "alias" : ["extensions",
           "user content"],
@@ -313847,7 +316518,6 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           },
           {
@@ -313855,7 +316525,6 @@
             "severity" : "error",
             "human" : "Must have either extensions or value[x], not both",
             "expression" : "extension.exists() != value.exists()",
-            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
             "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
           }],
           "isModifier" : false,
@@ -313866,10 +316535,10 @@
           }]
         },
         {
-          "id" : "ResearchStudy.objective.modifierExtension",
-          "path" : "ResearchStudy.objective.modifierExtension",
+          "id" : "ResearchStudy.outcomeMeasure.modifierExtension",
+          "path" : "ResearchStudy.outcomeMeasure.modifierExtension",
           "short" : "Extensions that cannot be ignored even if unrecognized",
-          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
+          "definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
           "comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
           "requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
           "alias" : ["extensions",
@@ -313890,7 +316559,6 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           },
           {
@@ -313898,7 +316566,6 @@
             "severity" : "error",
             "human" : "Must have either extensions or value[x], not both",
             "expression" : "extension.exists() != value.exists()",
-            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
             "source" : "http://hl7.org/fhir/StructureDefinition/Extension"
           }],
           "isModifier" : true,
@@ -313910,14 +316577,14 @@
           }]
         },
         {
-          "id" : "ResearchStudy.objective.name",
-          "path" : "ResearchStudy.objective.name",
-          "short" : "Label for the objective",
-          "definition" : "Unique, human-readable label for this objective of the study.",
+          "id" : "ResearchStudy.outcomeMeasure.name",
+          "path" : "ResearchStudy.outcomeMeasure.name",
+          "short" : "Label for the outcome",
+          "definition" : "Label for the outcome.",
           "min" : 0,
           "max" : "1",
           "base" : {
-            "path" : "ResearchStudy.objective.name",
+            "path" : "ResearchStudy.outcomeMeasure.name",
             "min" : 0,
             "max" : "1"
           },
@@ -313929,27 +316596,23 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
-          "isSummary" : false,
-          "mapping" : [{
-            "identity" : "BRIDG5.1",
-            "map" : "No BRIDG mapping (BRIDG has a description, but not a name)"
-          }]
+          "isSummary" : false
         },
         {
-          "id" : "ResearchStudy.objective.type",
-          "path" : "ResearchStudy.objective.type",
+          "id" : "ResearchStudy.outcomeMeasure.type",
+          "path" : "ResearchStudy.outcomeMeasure.type",
           "short" : "primary | secondary | exploratory",
-          "definition" : "The kind of study objective.",
+          "definition" : "The parameter or characteristic being assessed as one of the values by which the study is assessed.",
           "min" : 0,
-          "max" : "1",
+          "max" : "*",
           "base" : {
-            "path" : "ResearchStudy.objective.type",
+            "path" : "ResearchStudy.outcomeMeasure.type",
             "min" : 0,
-            "max" : "1"
+            "max" : "*"
           },
           "type" : [{
             "code" : "CodeableConcept"
@@ -313959,9 +316622,9 @@
             "severity" : "error",
             "human" : "All FHIR elements must have a @value or children",
             "expression" : "hasValue() or (children().count() > id.count())",
-            "xpath" : "@value|f:*|h:div",
             "source" : "http://hl7.org/fhir/StructureDefinition/Element"
           }],
+          "mustSupport" : false,
           "isModifier" : false,
           "isSummary" : false,
           "binding" : {
@@ -313970,13 +316633,91 @@
               "valueString" : "ResearchStudyObjectiveType"
             }],
             "strength" : "preferred",
-            "description" : "Codes for the kind of study objective.",
+            "description" : "defn.",
             "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
+          }
+        },
+        {
+          "id" : "ResearchStudy.outcomeMeasure.description",
+          "path" : "ResearchStudy.outcomeMeasure.description",
+          "short" : "Description of the outcome",
+          "definition" : "Description of the outcome.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.outcomeMeasure.description",
+            "min" : 0,
+            "max" : "1"
           },
-          "mapping" : [{
-            "identity" : "BRIDG5.1",
-            "map" : "StudyObjective.typeCode"
-          }]
+          "type" : [{
+            "code" : "markdown"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.outcomeMeasure.reference",
+          "path" : "ResearchStudy.outcomeMeasure.reference",
+          "short" : "Structured outcome definition",
+          "definition" : "Structured outcome definition.",
+          "min" : 0,
+          "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.outcomeMeasure.reference",
+            "min" : 0,
+            "max" : "1"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceVariable"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : false
+        },
+        {
+          "id" : "ResearchStudy.result",
+          "path" : "ResearchStudy.result",
+          "short" : "Link to results generated during the study",
+          "definition" : "Link to one or more sets of results generated by the study.  Could also link to a research registry holding the results such as ClinicalTrials.gov.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.result",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "Reference",
+            "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/EvidenceReport",
+            "http://hl7.org/fhir/StructureDefinition/Citation",
+            "http://hl7.org/fhir/StructureDefinition/DiagnosticReport"]
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true
         }]
       },
       "differential" : {
@@ -314103,24 +316844,41 @@
         {
           "id" : "ResearchStudy.status",
           "path" : "ResearchStudy.status",
-          "short" : "active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn",
-          "definition" : "The current state of the study.",
+          "short" : "draft | active | retired | unknown",
+          "definition" : "The publication state of the resource (not of the study).",
           "min" : 1,
           "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.status",
+            "min" : 1,
+            "max" : "1"
+          },
           "type" : [{
             "code" : "code"
           }],
+          "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" : false,
           "isModifier" : true,
           "isModifierReason" : "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid",
           "isSummary" : true,
           "binding" : {
             "extension" : [{
               "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
-              "valueString" : "ResearchStudyStatus"
+              "valueString" : "PublicationStatus"
+            },
+            {
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
+              "valueBoolean" : true
             }],
             "strength" : "required",
-            "description" : "Codes that convey the current status of the research study.",
-            "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-status|4.0.1"
+            "description" : "Codes that convey the current publication status of the research study resource.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|5.0.0"
           },
           "mapping" : [{
             "identity" : "w5",
@@ -314139,19 +316897,33 @@
           "id" : "ResearchStudy.primaryPurposeType",
           "path" : "ResearchStudy.primaryPurposeType",
           "short" : "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
-          "definition" : "The type of study based upon the intent of the study's activities. A classification of the intent of the study.",
+          "definition" : "The type of study based upon the intent of the study activities. A classification of the intent of the study.",
           "min" : 0,
           "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.primaryPurposeType",
+            "min" : 0,
+            "max" : "1"
+          },
           "type" : [{
             "code" : "CodeableConcept"
           }],
+          "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" : false,
+          "isModifier" : false,
           "isSummary" : true,
           "binding" : {
             "extension" : [{
               "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
               "valueString" : "ResearchStudyPrimaryPurposeType"
             }],
-            "strength" : "extensible",
+            "strength" : "preferred",
             "description" : "Codes for the main intent of the study.",
             "valueSet" : "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"
           },
@@ -314167,9 +316939,23 @@
           "definition" : "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
           "min" : 0,
           "max" : "1",
+          "base" : {
+            "path" : "ResearchStudy.phase",
+            "min" : 0,
+            "max" : "1"
+          },
           "type" : [{
             "code" : "CodeableConcept"
           }],
+          "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" : false,
+          "isModifier" : false,
           "isSummary" : true,
           "binding" : {
             "extension" : [{
@@ -314189,6 +316975,49 @@
             "map" : "StudyProtocolVersion.phaseCode"
           }]
         },
+        {
+          "id" : "ResearchStudy.studyDesign",
+          "path" : "ResearchStudy.studyDesign",
+          "short" : "Classifications of the study design characteristics",
+          "definition" : "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
+          "min" : 0,
+          "max" : "*",
+          "base" : {
+            "path" : "ResearchStudy.studyDesign",
+            "min" : 0,
+            "max" : "*"
+          },
+          "type" : [{
+            "code" : "CodeableConcept"
+          }],
+          "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" : false,
+          "isModifier" : false,
+          "isSummary" : true,
+          "binding" : {
+            "extension" : [{
+              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
+              "valueString" : "StudyDesign"
+            }],
+            "strength" : "preferred",
+            "description" : "This is a set of terms for study design characteristics.",
+            "valueSet" : "http://hl7.org/fhir/ValueSet/study-design"
+          },
+          "mapping" : [{
+            "identity" : "clinicaltrials-gov",
+            "map" : "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
+          },
+          {
+            "identity" : "BRIDG5.1",
+            "map" : "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
+          }]
+        },
         {
           "id" : "ResearchStudy.category",
           "path" : "ResearchStudy.category",
@@ -314305,13 +317134,16 @@
         {
           "id" : "ResearchStudy.relatedArtifact",
           "path" : "ResearchStudy.relatedArtifact",
-          "short" : "References and dependencies",
-          "definition" : "Citations, references and other related documents.",
+          "short" : "References, URLs, and attachments",
+          "definition" : "Citations, references, URLs and other related documents.  When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of \"documentation\" or \"supported-with\" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.",
           "min" : 0,
           "max" : "*",
           "type" : [{
             "code" : "RelatedArtifact"
           }],
+          "mustSupport" : false,
+          "isModifier" : false,
+          "isSummary" : false,
           "mapping" : [{
             "identity" : "clinicaltrials-gov",
             "map" : "Citations, Links, Available Study Data/Documents"