{
  "description": null,
  "_filename": "profile-researchstudy-clinical-site-0.1.json",
  "package_name": "dev.cihub.ClinicalSite.org",
  "date": "2019-04-23",
  "derivation": "constraint",
  "publisher": "Uniklinik Köln",
  "fhirVersion": "3.0.1",
  "name": "researchstudy-clinical-site-0.1",
  "abstract": false,
  "type": "ResearchStudy",
  "experimental": null,
  "resourceType": "StructureDefinition",
  "title": "Clinical Site: Research Study",
  "package_version": "0.0.1",
  "snapshot": {
    "element": [ {
      "constraint": [ {
        "key": "dom-2",
        "human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
        "xpath": "not(parent::f:contained and f:contained)",
        "severity": "error",
        "expression": "contained.contained.empty()"
      }, {
        "key": "dom-1",
        "human": "If the resource is contained in another resource, it SHALL NOT contain any narrative",
        "xpath": "not(parent::f:contained and f:text)",
        "severity": "error",
        "expression": "contained.text.empty()"
      }, {
        "key": "dom-4",
        "human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
        "xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
        "severity": "error",
        "expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
      }, {
        "key": "dom-3",
        "human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource",
        "xpath": "not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))",
        "severity": "error",
        "expression": "contained.where(('#'+id in %resource.descendants().reference).not()).empty()"
      } ],
      "path": "ResearchStudy",
      "min": 0,
      "definition": "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.  This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques.  A ResearchStudy involves the gathering of information about human or animal subjects.",
      "short": "Investigation to increase healthcare-related patient-independent knowledge",
      "mapping": [ {
        "map": "Entity. Role, or Act",
        "identity": "rim"
      }, {
        "map": "OBX",
        "identity": "v2"
      }, {
        "map": "Observation[classCode=CLNTRL, moodCode=EVN]",
        "identity": "rim"
      }, {
        "map": "clinical.diagnostics",
        "identity": "w5"
      } ],
      "alias": [ "Clinical Trial", "Study" ],
      "max": "*",
      "id": "ResearchStudy",
      "comment": "Need to make sure we encompass public health studies.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Resource"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.id",
      "min": 0,
      "definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
      "short": "Logical id of this artifact",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "id"
      } ],
      "max": "1",
      "id": "ResearchStudy.id",
      "condition": [ "ele-1" ],
      "comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Resource.id"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.meta",
      "min": 0,
      "definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.",
      "short": "Metadata about the resource",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Meta"
      } ],
      "max": "1",
      "id": "ResearchStudy.meta",
      "condition": [ "ele-1" ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Resource.meta"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.implicitRules",
      "min": 0,
      "definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.",
      "isModifier": true,
      "short": "A set of rules under which this content was created",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "max": "1",
      "id": "ResearchStudy.implicitRules",
      "condition": [ "ele-1" ],
      "comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. \n\nThis element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Resource.implicitRules"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.language",
      "min": 0,
      "definition": "The base language in which the resource is written.",
      "short": "Language of the resource content",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
          "valueReference": {
            "reference": "http://hl7.org/fhir/ValueSet/all-languages"
          }
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "Language"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A human language.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/languages"
        }
      },
      "max": "1",
      "id": "ResearchStudy.language",
      "condition": [ "ele-1" ],
      "comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource  Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Resource.language"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.text",
      "min": 0,
      "definition": "A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
      "short": "Text summary of the resource, for human interpretation",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      }, {
        "map": "Act.text?",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Narrative"
      } ],
      "alias": [ "narrative", "html", "xhtml", "display" ],
      "max": "1",
      "id": "ResearchStudy.text",
      "condition": [ "ele-1", "dom-1" ],
      "comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded in formation is added later.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "DomainResource.text"
      }
    }, {
      "path": "ResearchStudy.contained",
      "min": 0,
      "definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
      "short": "Contained, inline Resources",
      "mapping": [ {
        "map": "Entity. Role, or Act",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Resource"
      } ],
      "alias": [ "inline resources", "anonymous resources", "contained resources" ],
      "max": "*",
      "id": "ResearchStudy.contained",
      "comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "DomainResource.contained"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the resource. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "DomainResource.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.modifierExtension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
      "isModifier": true,
      "short": "Extensions that cannot be ignored",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.modifierExtension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "DomainResource.modifierExtension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 3,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "slicing": {
        "rules": "closed",
        "discriminator": [ {
          "path": "system",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "max": "*",
      "id": "ResearchStudy.identifier",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 1,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "pruefplancode",
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:pruefplancode.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/pruefplancode",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:pruefplancode.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 1,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "eudraCtNr",
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:eudraCtNr.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/eudraCtNr",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:eudraCtNr.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 0,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "nummerEthikkommission",
      "max": "*",
      "id": "ResearchStudy.identifier:nummerEthikkommission",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:nummerEthikkommission.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/nummerEthikkommission",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:nummerEthikkommission.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 0,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "nummerKoeln",
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:nummerKoeln.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/nummerKoeln",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:nummerKoeln.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 0,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "isrctn",
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:isrctn.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/isrctn",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:isrctn.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 0,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "clinicaltrialsGov",
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/clinicaltrialsGov",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:clinicaltrialsGov.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier",
      "requirements": "Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
      "min": 0,
      "definition": "Identifiers assigned to this research study by the sponsor or other systems.",
      "short": "Business Identifier for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)",
        "identity": "v2"
      }, {
        "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs.  Also maps to Role[classCode=IDENT]",
        "identity": "rim"
      }, {
        "map": "Identifier",
        "identity": "servd"
      }, {
        "map": "Organization's Unique Protocol ID; Secondary IDs",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".identifier",
        "identity": "rim"
      }, {
        "map": "id",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Identifier"
      } ],
      "mustSupport": true,
      "sliceName": "drks",
      "max": "1",
      "id": "ResearchStudy.identifier:drks",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.identifier"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.identifier:drks.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.identifier.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.identifier:drks.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.use",
      "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
      "min": 0,
      "definition": "The purpose of this identifier.",
      "isModifier": true,
      "short": "usual | official | temp | secondary (If known)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierUse"
        } ],
        "description": "Identifies the purpose for this identifier, if known .",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-use"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:drks.use",
      "condition": [ "ele-1" ],
      "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.use"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.type",
      "requirements": "Allows users to make use of identifiers when the identifier system is not known.",
      "min": 0,
      "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
      "short": "Description of identifier",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "CX.5",
        "identity": "v2"
      }, {
        "map": "Role.code or implied by context",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "extensible",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "IdentifierType"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/identifier-type"
        }
      },
      "max": "1",
      "id": "ResearchStudy.identifier:drks.type",
      "condition": [ "ele-1" ],
      "comment": "This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.type"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.system",
      "requirements": "There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.",
      "min": 1,
      "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
      "short": "The namespace for the identifier value",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/drks",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.4 / EI-2-4",
        "identity": "v2"
      }, {
        "map": "II.root or Role.id.root",
        "identity": "rim"
      }, {
        "map": "./IdentifierType",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:drks.system",
      "condition": [ "ele-1" ],
      "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier",
      "example": [ {
        "label": "General",
        "valueUri": "http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.identifier.value",
      "min": 1,
      "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
      "short": "The value that is unique",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CX.1 / EI.1",
        "identity": "v2"
      }, {
        "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)",
        "identity": "rim"
      }, {
        "map": "./Value",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.identifier:drks.value",
      "condition": [ "ele-1" ],
      "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).",
      "example": [ {
        "label": "General",
        "valueString": "123456"
      } ],
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.value"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.identifier.period",
      "min": 0,
      "definition": "Time period during which identifier is/was valid for use.",
      "short": "Time period when id is/was valid for use",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "CX.7 + CX.8",
        "identity": "v2"
      }, {
        "map": "Role.effectiveTime or implied by context",
        "identity": "rim"
      }, {
        "map": "./StartDate and ./EndDate",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:drks.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.identifier.assigner",
      "min": 0,
      "definition": "Organization that issued/manages the identifier.",
      "short": "Organization that issued id (may be just text)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "CX.4 / (CX.4,CX.9,CX.10)",
        "identity": "v2"
      }, {
        "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper",
        "identity": "rim"
      }, {
        "map": "./IdentifierIssuingAuthority",
        "identity": "servd"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Organization"
      } ],
      "max": "1",
      "id": "ResearchStudy.identifier:drks.assigner",
      "condition": [ "ele-1" ],
      "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Identifier.assigner"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.title",
      "min": 1,
      "definition": "A short, descriptive user-friendly label for the study.",
      "short": "Name for this study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Brief Title",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.title",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.title"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.protocol",
      "min": 0,
      "definition": "The set of steps expected to be performed as part of the execution of the study.",
      "short": "Steps followed in executing study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "Interventions; Arm/Intervention Cross-Reference",
        "identity": "clinicaltrials-gov"
      }, {
        "map": ".outboundRelationship[typeCode=DEFN].target",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
      } ],
      "max": "*",
      "id": "ResearchStudy.protocol",
      "condition": [ "ele-1" ],
      "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.protocol"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.partOf",
      "requirements": "Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
      "min": 0,
      "definition": "A larger research study of which this particular study is a component or step.",
      "short": "Part of larger study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
      } ],
      "alias": [ "container" ],
      "max": "*",
      "id": "ResearchStudy.partOf",
      "condition": [ "ele-1" ],
      "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.partOf"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.status",
      "min": 1,
      "definition": "The current state of the study.",
      "isModifier": true,
      "short": "draft | in-progress | suspended | stopped | completed | entered-in-error",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": ".status",
        "identity": "rim"
      }, {
        "map": "status",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "mustSupport": true,
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "ResearchStudyStatus"
        } ],
        "description": "Codes that convey the current status of the research study",
        "valueSetReference": {
          "reference": "http://hl7.org/fhir/ValueSet/research-study-status"
        }
      },
      "max": "1",
      "id": "ResearchStudy.status",
      "condition": [ "ele-1" ],
      "comment": "This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "ResearchStudy.status"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.category",
      "min": 0,
      "definition": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
      "short": "Classifications for the study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "example",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "ResearchStudyCategory"
        } ],
        "description": "Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational, blinding type, etc."
      },
      "max": "*",
      "id": "ResearchStudy.category",
      "condition": [ "ele-1" ],
      "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.category"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.focus",
      "min": 0,
      "definition": "The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
      "short": "Drugs, devices, conditions, etc. under study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "Conditions or Focus of Study",
        "identity": "clinicaltrials-gov"
      }, {
        "map": "what",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "example",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "ResearchStudyFocus"
        } ],
        "description": "Codes for medications, devices, conditions and other interventions"
      },
      "max": "*",
      "id": "ResearchStudy.focus",
      "condition": [ "ele-1" ],
      "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.focus"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.contact",
      "min": 0,
      "definition": "Contact details to assist a user in learning more about or engaging with the study.",
      "short": "Contact details for the study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "ContactDetail"
      } ],
      "max": "*",
      "id": "ResearchStudy.contact",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.contact"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.relatedArtifact",
      "min": 0,
      "definition": "Citations, references and other related documents.",
      "short": "References and dependencies",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Citations, Links, Available Study Data/Documents",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "RelatedArtifact"
      } ],
      "max": "*",
      "id": "ResearchStudy.relatedArtifact",
      "condition": [ "ele-1" ],
      "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.relatedArtifact"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.keyword",
      "min": 0,
      "definition": "Key terms to aid in searching for or filtering the study.",
      "short": "Used to search for the study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "Keywords",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "binding": {
        "strength": "example",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "ResearchStudyKeyword"
        } ],
        "description": "Words associated with the study that may be useful in discovery"
      },
      "max": "*",
      "id": "ResearchStudy.keyword",
      "condition": [ "ele-1" ],
      "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.keyword"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction",
      "min": 1,
      "definition": "Indicates a country, state or other region where the study is taking place.",
      "short": "Geographic region(s) for study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "mustSupport": true,
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString": "Jurisdiction"
        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "description": "Countries and regions within which this artifact is targeted for use",
        "valueSetUri": "http://uk-koeln.de/fhir/ValueSet/clinical-site/rechtsgrundlage"
      },
      "max": "1",
      "id": "ResearchStudy.jurisdiction",
      "condition": [ "ele-1" ],
      "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.jurisdiction"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.jurisdiction.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.jurisdiction.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.jurisdiction.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding",
      "requirements": "Allows for translations and alternate encodings within a code system.  Also supports communication of the same instance to systems requiring different encodings.",
      "min": 1,
      "definition": "A reference to a code defined by a terminology system.",
      "short": "Code defined by a terminology system",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE subset one of the sets of component 1-3 or 4-6",
        "identity": "v2"
      }, {
        "map": "CV",
        "identity": "rim"
      }, {
        "map": "fhir:Coding rdfs:subClassOf dt:CDCoding",
        "identity": "orim"
      }, {
        "map": "C*E.1-8, C*E.10-22",
        "identity": "v2"
      }, {
        "map": "union(., ./translation)",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "Coding"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding",
      "condition": [ "ele-1" ],
      "comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "CodeableConcept.coding"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.jurisdiction.coding.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.system",
      "requirements": "Need to be unambiguous about the source of the definition of the symbol.",
      "min": 1,
      "definition": "The identification of the code system that defines the meaning of the symbol in the code.",
      "short": "Identity of the terminology system",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "C*E.3",
        "identity": "v2"
      }, {
        "map": "./codeSystem",
        "identity": "rim"
      }, {
        "map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding.system",
      "condition": [ "ele-1" ],
      "comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Coding.system"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.version",
      "min": 0,
      "definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
      "short": "Version of the system - if relevant",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "C*E.7",
        "identity": "v2"
      }, {
        "map": "./codeSystemVersion",
        "identity": "rim"
      }, {
        "map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding.version",
      "condition": [ "ele-1" ],
      "comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Coding.version"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.code",
      "requirements": "Need to refer to a particular code in the system.",
      "min": 1,
      "definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
      "short": "Symbol in syntax defined by the system",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "C*E.1",
        "identity": "v2"
      }, {
        "map": "./code",
        "identity": "rim"
      }, {
        "map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "code"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding.code",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Coding.code"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.display",
      "requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know  the system.",
      "min": 0,
      "definition": "A representation of the meaning of the code in the system, following the rules of the system.",
      "short": "Representation defined by the system",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "C*E.2 - but note this is not well followed",
        "identity": "v2"
      }, {
        "map": "CV.displayName",
        "identity": "rim"
      }, {
        "map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
        "valueBoolean": true
      } ],
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding.display",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Coding.display"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.coding.userSelected",
      "requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
      "min": 0,
      "definition": "Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).",
      "short": "If this coding was chosen directly by the user",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Sometimes implied by being first",
        "identity": "v2"
      }, {
        "map": "CD.codingRationale",
        "identity": "rim"
      }, {
        "map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [     fhir:source \"true\";     fhir:target dt:CDCoding.codingRationale\\#O   ]",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "boolean"
      } ],
      "max": "1",
      "id": "ResearchStudy.jurisdiction.coding.userSelected",
      "condition": [ "ele-1" ],
      "comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Coding.userSelected"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.jurisdiction.text",
      "requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
      "min": 0,
      "definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
      "short": "Plain text representation of the concept",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "C*E.9. But note many systems use C*E.2 for this",
        "identity": "v2"
      }, {
        "map": "./originalText[mediaType/code=\"text/plain\"]/data",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
        "identity": "orim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
        "valueBoolean": true
      } ],
      "max": "1",
      "id": "ResearchStudy.jurisdiction.text",
      "condition": [ "ele-1" ],
      "comment": "Very often the text is the same as a displayName of one of the codings.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "CodeableConcept.text"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.description",
      "min": 0,
      "definition": "A full description of how the study is being conducted.",
      "short": "What this is study doing",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Detailed Description",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "markdown"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.description",
      "condition": [ "ele-1" ],
      "comment": "Systems are not required to have markdown support, and there is considerable variation in markdown syntax, so the text should be readable without markdown processing. The preferred markdown syntax is described here: http://daringfireball.net/projects/markdown/syntax (and tests here: http://daringfireball.net/projects/downloads/MarkdownTest_1.0.zip)",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.description"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.description.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.description.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.description.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.description.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.description.extension",
      "min": 0,
      "definition": "Optional Extension Element - found in all resources.",
      "short": "Optional Extensions Element",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Extension",
        "profile": "http://uk-koeln.de/fhir/StructureDefinition/Extension/clinical-site/researchstudy-description-en/0.1"
      } ],
      "mustSupport": true,
      "sliceName": "description-en",
      "alias": [ "extensions", "user content" ],
      "max": "1",
      "id": "ResearchStudy.description.extension:description-en",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.description.extension.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.description.extension:description-en.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.description.extension.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.description.extension:description-en.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.description.extension.url",
      "min": 1,
      "definition": "Source of the definition for the extension code - a logical name or a URL.",
      "short": "identifies the meaning of the extension",
      "fixedUri": "http://uk-koeln.de/fhir/StructureDefinition/Extension/clinical-site/researchstudy-description-en/0.1",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "uri"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.description.extension:description-en.url",
      "condition": [ "ele-1" ],
      "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
      "base": {
        "max": "1",
        "min": 1,
        "path": "Extension.url"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.description.extension.valueMarkdown",
      "min": 1,
      "definition": "Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).",
      "short": "Value of extension",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "markdown"
      } ],
      "mustSupport": true,
      "sliceName": "valueMarkdown",
      "max": "1",
      "id": "ResearchStudy.description.extension:description-en.valueMarkdown:valueMarkdown",
      "condition": [ "ele-1" ],
      "comment": "A stream of bytes, base64 encoded",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Extension.value[x]"
      }
    }, {
      "path": "ResearchStudy.description.value",
      "min": 0,
      "definition": "Primitive value for markdown",
      "short": "Primitive value for markdown",
      "type": [ {
        "_code": {
          "extension": [ {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-json-type",
            "valueString": "string"
          }, {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-xml-type",
            "valueString": "xsd:string"
          }, {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-rdf-type",
            "valueString": "xsd:string"
          } ]
        }
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.description.value",
      "maxLength": 1048576,
      "base": {
        "max": "1",
        "min": 0,
        "path": "string.value"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.enrollment",
      "min": 0,
      "definition": "Reference to a Group that defines the criteria for and quantity of subjects participating in the study.  E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\".",
      "short": "Inclusion & exclusion criteria",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "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": "clinicaltrials-gov"
      }, {
        "map": "who.focus",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Group"
      } ],
      "alias": [ "patient" ],
      "max": "*",
      "id": "ResearchStudy.enrollment",
      "condition": [ "ele-1" ],
      "comment": "The Group referenced should not generally enumerate specific subjects.  Subjects will be linked to the study using the ResearchSubject resource.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.enrollment"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "per-1",
        "human": "If present, start SHALL have a lower value than end",
        "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)",
        "severity": "error",
        "expression": "start.empty() or end.empty() or (start <= end)"
      } ],
      "path": "ResearchStudy.period",
      "requirements": "[The list of types may be constrained as appropriate for the type of event].",
      "min": 0,
      "definition": "Identifies the start date and the expected (or actual, depending on status) end date for the study.",
      "short": "When the study began and ended",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "DR",
        "identity": "v2"
      }, {
        "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]",
        "identity": "rim"
      }, {
        "map": "Study Start Date (start); Study Completion Date (end)",
        "identity": "clinicaltrials-gov"
      }, {
        "map": "when.done",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Period"
      } ],
      "alias": [ "timing" ],
      "max": "1",
      "id": "ResearchStudy.period",
      "condition": [ "ele-1" ],
      "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.period"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.sponsor",
      "min": 0,
      "definition": "The organization responsible for the execution of the study.",
      "short": "Organization responsible for the study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "Sponsor",
        "identity": "clinicaltrials-gov"
      }, {
        "map": "who.actor",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://uk-koeln.de/fhir/StructureDefinition/Organization/clinical-site/0.1"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.sponsor",
      "condition": [ "ele-1" ],
      "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.sponsor"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.principalInvestigator",
      "min": 0,
      "definition": "Indicates the individual who has primary oversite of the execution of the study.",
      "short": "The individual responsible for the study",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "Principal Investigator",
        "identity": "clinicaltrials-gov"
      }, {
        "map": "who.actor",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://uk-koeln.de/fhir/StructureDefinition/Practitioner/clinical-site/0.1"
      } ],
      "mustSupport": true,
      "max": "1",
      "id": "ResearchStudy.principalInvestigator",
      "condition": [ "ele-1" ],
      "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.principalInvestigator"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ref-1",
        "human": "SHALL have a contained resource if a local reference is provided",
        "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])",
        "severity": "error",
        "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))"
      } ],
      "path": "ResearchStudy.site",
      "min": 0,
      "definition": "Clinic, hospital or other healthcare location that is participating in the study.",
      "short": "Location involved in study execution",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)",
        "identity": "rim"
      }, {
        "map": "Facility",
        "identity": "clinicaltrials-gov"
      }, {
        "map": "where",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "Reference",
        "targetProfile": "http://hl7.org/fhir/StructureDefinition/Location"
      } ],
      "max": "*",
      "id": "ResearchStudy.site",
      "condition": [ "ele-1" ],
      "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.site"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.reasonStopped",
      "min": 0,
      "definition": "A description and/or code explaining the premature termination of the study.",
      "short": "Reason for terminating study early",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "Why Study Stopped",
        "identity": "clinicaltrials-gov"
      }, {
        "map": "why",
        "identity": "w5"
      } ],
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "max": "1",
      "id": "ResearchStudy.reasonStopped",
      "condition": [ "ele-1" ],
      "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.reasonStopped"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.note",
      "min": 0,
      "definition": "Comments made about the event by the performer, subject or other participants.",
      "short": "Comments made about the event",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "v2"
      }, {
        "map": "Act",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Annotation"
      } ],
      "max": "*",
      "id": "ResearchStudy.note",
      "condition": [ "ele-1" ],
      "comment": "For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time.  This element may need to be included in narrative because of the potential for modifying information.  *Annotations SHOULD NOT* be used to communicate \"modifying\" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).",
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.note"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.arm",
      "min": 0,
      "definition": "Describes an expected sequence of events for one of the participants of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.",
      "short": "Defined path through the study for a subject",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Arms",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "BackboneElement"
      } ],
      "max": "*",
      "id": "ResearchStudy.arm",
      "condition": [ "ele-1" ],
      "base": {
        "max": "*",
        "min": 0,
        "path": "ResearchStudy.arm"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.arm.id",
      "min": 0,
      "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
      "short": "xml:id (or equivalent in JSON)",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "representation": [ "xmlAttr" ],
      "max": "1",
      "id": "ResearchStudy.arm.id",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "Element.id"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.arm.extension",
      "min": 0,
      "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
      "short": "Additional Content defined by implementations",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "slicing": {
        "rules": "open",
        "description": "Extensions are always sliced by (at least) url",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      },
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content" ],
      "max": "*",
      "id": "ResearchStudy.arm.extension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "Element.extension"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      }, {
        "key": "ext-1",
        "human": "Must have either extensions or value[x], not both",
        "xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
        "severity": "error",
        "expression": "extension.exists() != value.exists()"
      } ],
      "path": "ResearchStudy.arm.modifierExtension",
      "min": 0,
      "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 that contains it. Usually modifier elements provide negation or qualification. In order 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
      "isModifier": true,
      "short": "Extensions that cannot be ignored",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "N/A",
        "identity": "rim"
      } ],
      "type": [ {
        "code": "Extension"
      } ],
      "alias": [ "extensions", "user content", "modifiers" ],
      "max": "*",
      "id": "ResearchStudy.arm.modifierExtension",
      "condition": [ "ele-1" ],
      "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.",
      "base": {
        "max": "*",
        "min": 0,
        "path": "BackboneElement.modifierExtension"
      },
      "isSummary": true
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.arm.name",
      "min": 1,
      "definition": "Unique, human-readable label for this arm of the study.",
      "short": "Label for study arm",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Arm Label",
        "identity": "clinicaltrials-gov"
      } ],
      "type": [ {
        "code": "string"
      } ],
      "max": "1",
      "id": "ResearchStudy.arm.name",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 1,
        "path": "ResearchStudy.arm.name"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.arm.code",
      "min": 0,
      "definition": "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
      "short": "Categorization of study arm",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "CE/CNE/CWE",
        "identity": "v2"
      }, {
        "map": "CD",
        "identity": "rim"
      }, {
        "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD",
        "identity": "orim"
      }, {
        "map": "Arm Type",
        "identity": "clinicaltrials-gov"
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      "type": [ {
        "code": "CodeableConcept"
      } ],
      "max": "1",
      "id": "ResearchStudy.arm.code",
      "condition": [ "ele-1" ],
      "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.arm.code"
      }
    }, {
      "constraint": [ {
        "key": "ele-1",
        "human": "All FHIR elements must have a @value or children",
        "xpath": "@value|f:*|h:div",
        "severity": "error",
        "expression": "hasValue() | (children().count() > id.count())"
      } ],
      "path": "ResearchStudy.arm.description",
      "min": 0,
      "definition": "A succinct description of the path through the study that would be followed by a subject adhering to this arm.",
      "short": "Short explanation of study path",
      "mapping": [ {
        "map": "n/a",
        "identity": "rim"
      }, {
        "map": "Arm Description",
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      } ],
      "type": [ {
        "code": "string"
      } ],
      "max": "1",
      "id": "ResearchStudy.arm.description",
      "condition": [ "ele-1" ],
      "comment": "Note that FHIR strings may not exceed 1MB in size",
      "base": {
        "max": "1",
        "min": 0,
        "path": "ResearchStudy.arm.description"
      }
    } ]
  },
  "status": "draft",
  "id": "22f640db-06e6-462b-a5ec-62c1637fc4bc",
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  "url": "http://uk-koeln.de/fhir/StructureDefinition/ResearchStudy/clinical-site/0.1",
  "version": "0.1",
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    "element": [ {
      "id": "ResearchStudy.identifier",
      "min": 3,
      "path": "ResearchStudy.identifier",
      "slicing": {
        "rules": "closed",
        "discriminator": [ {
          "path": "system",
          "type": "value"
        } ]
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    }, {
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      "min": 1,
      "path": "ResearchStudy.identifier.system",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/pruefplancode",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:pruefplancode.value",
      "min": 1,
      "path": "ResearchStudy.identifier.value",
      "mustSupport": true
    }, {
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      "min": 1,
      "path": "ResearchStudy.identifier",
      "sliceName": "eudraCtNr",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:eudraCtNr.system",
      "min": 1,
      "path": "ResearchStudy.identifier.system",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/eudraCtNr",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:eudraCtNr.value",
      "min": 1,
      "path": "ResearchStudy.identifier.value",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:nummerEthikkommission",
      "path": "ResearchStudy.identifier",
      "sliceName": "nummerEthikkommission",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:nummerEthikkommission.system",
      "min": 1,
      "path": "ResearchStudy.identifier.system",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/nummerEthikkommission",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:nummerEthikkommission.value",
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      "path": "ResearchStudy.identifier.value",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:nummerKoeln",
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      "path": "ResearchStudy.identifier",
      "sliceName": "nummerKoeln",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:nummerKoeln.system",
      "min": 1,
      "path": "ResearchStudy.identifier.system",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/nummerKoeln",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:nummerKoeln.value",
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      "path": "ResearchStudy.identifier.value",
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    }, {
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      "path": "ResearchStudy.identifier",
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    }, {
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      "path": "ResearchStudy.identifier.system",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/isrctn",
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    }, {
      "id": "ResearchStudy.identifier:isrctn.value",
      "min": 1,
      "path": "ResearchStudy.identifier.value",
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      "id": "ResearchStudy.identifier:clinicaltrialsGov",
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      "fixedUri": "http://uk-koeln.de/fhir/identifiers/clinicaltrialsGov",
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    }, {
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      "path": "ResearchStudy.identifier.value",
      "mustSupport": true
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      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:drks.system",
      "min": 1,
      "path": "ResearchStudy.identifier.system",
      "fixedUri": "http://uk-koeln.de/fhir/identifiers/drks",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.identifier:drks.value",
      "min": 1,
      "path": "ResearchStudy.identifier.value",
      "mustSupport": true
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      "min": 1,
      "path": "ResearchStudy.title",
      "mustSupport": true
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      "path": "ResearchStudy.status",
      "mustSupport": true
    }, {
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      "min": 1,
      "path": "ResearchStudy.jurisdiction",
      "binding": {
        "strength": "required",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
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        }, {
          "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
          "valueBoolean": true
        } ],
        "valueSetUri": "http://uk-koeln.de/fhir/ValueSet/clinical-site/rechtsgrundlage"
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    }, {
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      "min": 1,
      "path": "ResearchStudy.jurisdiction.coding",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.jurisdiction.coding.system",
      "min": 1,
      "path": "ResearchStudy.jurisdiction.coding.system",
      "mustSupport": true
    }, {
      "id": "ResearchStudy.jurisdiction.coding.code",
      "min": 1,
      "path": "ResearchStudy.jurisdiction.coding.code",
      "mustSupport": true
    }, {
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      "path": "ResearchStudy.description",
      "mustSupport": true
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          "type": "value"
        } ]
      }
    }, {
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      "min": 0,
      "path": "ResearchStudy.description.extension",
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        "profile": "http://uk-koeln.de/fhir/StructureDefinition/Extension/clinical-site/researchstudy-description-en/0.1"
      } ],
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    }, {
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      } ],
      "mustSupport": true
    }, {
      "id": "ResearchStudy.principalInvestigator",
      "path": "ResearchStudy.principalInvestigator",
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    } ]
  },
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
}