<status value="draft" /> <date value="2019-04-23" /> <publisher value="Uniklinik Köln" /> <fhirVersion value="3.0.1" /> <kind value="resource" /> <abstract value="false" /> <type value="ResearchStudy" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" /> <derivation value="constraint" /> <snapshot> <element id="ResearchStudy"> <path value="ResearchStudy" /> <short value="Investigation to increase healthcare-related patient-independent knowledge" /> <definition value="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." /> <comment value="Need to make sure we encompass public health studies." /> <alias value="Clinical Trial" /> <alias value="Study" /> <min value="0" /> <max value="*" /> <base> <path value="Resource" /> <min value="0" /> <max value="*" /> </base> <constraint> <key value="dom-2" /> <severity value="error" /> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" /> <expression value="contained.contained.empty()" /> <xpath value="not(parent::f:contained and f:contained)" /> </constraint> <constraint> <key value="dom-1" /> <severity value="error" /> <human value="If the resource is contained in another resource, it SHALL NOT contain any narrative" /> <expression value="contained.text.empty()" /> <xpath value="not(parent::f:contained and f:text)" /> </constraint> <constraint> <key value="dom-4" /> <severity value="error" /> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" /> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" /> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" /> </constraint> <constraint> <key value="dom-3" /> <severity value="error" /> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource" /> <expression value="contained.where(('#'+id in %resource.descendants().reference).not()).empty()" /> <xpath value="not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))" /> </constraint> <mapping> <identity value="rim" /> <map value="Entity. Role, or Act" /> </mapping> <mapping> <identity value="v2" /> <map value="OBX" /> </mapping> <mapping> <identity value="rim" /> <map value="Observation[classCode=CLNTRL, moodCode=EVN]" /> </mapping> <mapping> <identity value="w5" /> <map value="clinical.diagnostics" /> </mapping> </element> <element id="ResearchStudy.id"> <path value="ResearchStudy.id" /> <short value="Logical id of this artifact" /> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." /> <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="id" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.meta"> <path value="ResearchStudy.meta" /> <short value="Metadata about the resource" /> <definition value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.meta" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Meta" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.implicitRules"> <path value="ResearchStudy.implicitRules" /> <short value="A set of rules under which this content was created" /> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content." /> <comment value="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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.implicitRules" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.language"> <path value="ResearchStudy.language" /> <short value="Language of the resource content" /> <definition value="The base language in which the resource is written." /> <comment value="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)." /> <min value="0" /> <max value="1" /> <base> <path value="Resource.language" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueReference> <reference value="http://hl7.org/fhir/ValueSet/all-languages" /> </valueReference> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A human language." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/languages" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.text"> <path value="ResearchStudy.text" /> <short value="Text summary of the resource, for human interpretation" /> <definition value="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." /> <comment value="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." /> <alias value="narrative" /> <alias value="html" /> <alias value="xhtml" /> <alias value="display" /> <min value="0" /> <max value="1" /> <base> <path value="DomainResource.text" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Narrative" /> </type> <condition value="ele-1" /> <condition value="dom-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Act.text?" /> </mapping> </element> <element id="ResearchStudy.contained"> <path value="ResearchStudy.contained" /> <short value="Contained, inline Resources" /> <definition value="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." /> <comment value="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." /> <alias value="inline resources" /> <alias value="anonymous resources" /> <alias value="contained resources" /> <min value="0" /> <max value="*" /> <base> <path value="DomainResource.contained" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Resource" /> </type> <mapping> <identity value="rim" /> <map value="Entity. Role, or Act" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.extension"> <path value="ResearchStudy.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="DomainResource.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.modifierExtension"> <path value="ResearchStudy.modifierExtension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Extensions that cannot be ignored" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="DomainResource.modifierExtension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <isModifier value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier"> <path value="ResearchStudy.identifier" /> <slicing> <discriminator> <type value="value" /> <path value="system" /> </discriminator> <rules value="closed" /> </slicing> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="3" /> <max value="*" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode"> <path value="ResearchStudy.identifier" /> <sliceName value="pruefplancode" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="1" /> <max value="1" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/pruefplancode" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:pruefplancode.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr"> <path value="ResearchStudy.identifier" /> <sliceName value="eudraCtNr" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="1" /> <max value="1" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/eudraCtNr" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:eudraCtNr.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission"> <path value="ResearchStudy.identifier" /> <sliceName value="nummerEthikkommission" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/nummerEthikkommission" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln"> <path value="ResearchStudy.identifier" /> <sliceName value="nummerKoeln" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/nummerKoeln" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:nummerKoeln.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn"> <path value="ResearchStudy.identifier" /> <sliceName value="isrctn" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/isrctn" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:isrctn.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov"> <path value="ResearchStudy.identifier" /> <sliceName value="clinicaltrialsGov" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/clinicaltrialsGov" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.identifier:drks"> <path value="ResearchStudy.identifier" /> <sliceName value="drks" /> <short value="Business Identifier for study" /> <definition value="Identifiers assigned to this research study by the sponsor or other systems." /> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.identifier" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Identifier" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX / EI (occasionally, more often EI maps to a resource id or a URL)" /> </mapping> <mapping> <identity value="rim" /> <map value="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]" /> </mapping> <mapping> <identity value="servd" /> <map value="Identifier" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Organization's Unique Protocol ID; Secondary IDs" /> </mapping> <mapping> <identity value="rim" /> <map value=".identifier" /> </mapping> <mapping> <identity value="w5" /> <map value="id" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.id"> <path value="ResearchStudy.identifier.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.extension"> <path value="ResearchStudy.identifier.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.use"> <path value="ResearchStudy.identifier.use" /> <short value="usual | official | temp | secondary (If known)" /> <definition value="The purpose of this identifier." /> <comment value="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." /> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.use" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse" /> </extension> <strength value="required" /> <description value="Identifies the purpose for this identifier, if known ." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-use" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.type"> <path value="ResearchStudy.identifier.type" /> <short value="Description of identifier" /> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose." /> <comment value="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. Where 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." /> <requirements value="Allows users to make use of identifiers when the identifier system is not known." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.type" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="extensible" /> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose." /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/identifier-type" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.5" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.code or implied by context" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.system"> <path value="ResearchStudy.identifier.system" /> <short value="The namespace for the identifier value" /> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique." /> <comment value="see http://en.wikipedia.org/wiki/Uniform_resource_identifier" /> <requirements value="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 value="1" /> <max value="1" /> <base> <path value="Identifier.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/identifiers/drks" /> <example> <label value="General" /> <valueUri value="http://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / EI-2-4" /> </mapping> <mapping> <identity value="rim" /> <map value="II.root or Role.id.root" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierType" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.value"> <path value="ResearchStudy.identifier.value" /> <short value="The value that is unique" /> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system." /> <comment value="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)." /> <min value="1" /> <max value="1" /> <base> <path value="Identifier.value" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <example> <label value="General" /> <valueString value="123456" /> </example> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.1 / EI.1" /> </mapping> <mapping> <identity value="rim" /> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" /> </mapping> <mapping> <identity value="servd" /> <map value="./Value" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.period"> <path value="ResearchStudy.identifier.period" /> <short value="Time period when id is/was valid for use" /> <definition value="Time period during which identifier is/was valid for use." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.7 + CX.8" /> </mapping> <mapping> <identity value="rim" /> <map value="Role.effectiveTime or implied by context" /> </mapping> <mapping> <identity value="servd" /> <map value="./StartDate and ./EndDate" /> </mapping> </element> <element id="ResearchStudy.identifier:drks.assigner"> <path value="ResearchStudy.identifier.assigner" /> <short value="Organization that issued id (may be just text)" /> <definition value="Organization that issued/manages the identifier." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Identifier.assigner" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="v2" /> <map value="CX.4 / (CX.4,CX.9,CX.10)" /> </mapping> <mapping> <identity value="rim" /> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" /> </mapping> <mapping> <identity value="servd" /> <map value="./IdentifierIssuingAuthority" /> </mapping> </element> <element id="ResearchStudy.title"> <path value="ResearchStudy.title" /> <short value="Name for this study" /> <definition value="A short, descriptive user-friendly label for the study." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="1" /> <max value="1" /> <base> <path value="ResearchStudy.title" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Brief Title" /> </mapping> </element> <element id="ResearchStudy.protocol"> <path value="ResearchStudy.protocol" /> <short value="Steps followed in executing study" /> <definition value="The set of steps expected to be performed as part of the execution of the study." /> <comment value="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." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.protocol" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Interventions; Arm/Intervention Cross-Reference" /> </mapping> <mapping> <identity value="rim" /> <map value=".outboundRelationship[typeCode=DEFN].target" /> </mapping> </element> <element id="ResearchStudy.partOf"> <path value="ResearchStudy.partOf" /> <short value="Part of larger study" /> <definition value="A larger research study of which this particular study is a component or step." /> <comment value="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." /> <requirements value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc." /> <alias value="container" /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.partOf" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="rim" /> <map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" /> </mapping> </element> <element id="ResearchStudy.status"> <path value="ResearchStudy.status" /> <short value="draft | in-progress | suspended | stopped | completed | entered-in-error" /> <definition value="The current state of the study." /> <comment value="This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid." /> <min value="1" /> <max value="1" /> <base> <path value="ResearchStudy.status" /> <min value="1" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isModifier value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyStatus" /> </extension> <strength value="required" /> <description value="Codes that convey the current status of the research study" /> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/research-study-status" /> </valueSetReference> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value=".status" /> </mapping> <mapping> <identity value="w5" /> <map value="status" /> </mapping> </element> <element id="ResearchStudy.category"> <path value="ResearchStudy.category" /> <short value="Classifications for the study" /> <definition value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." /> <comment value="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." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.category" /> <min value="0" /> <max value="*" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyCategory" /> </extension> <strength value="example" /> <description value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc." /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" /> </mapping> </element> <element id="ResearchStudy.focus"> <path value="ResearchStudy.focus" /> <short value="Drugs, devices, conditions, etc. under study" /> <definition value="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." /> <comment value="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." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.focus" /> <min value="0" /> <max value="*" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyFocus" /> </extension> <strength value="example" /> <description value="Codes for medications, devices, conditions and other interventions" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Conditions or Focus of Study" /> </mapping> <mapping> <identity value="w5" /> <map value="what" /> </mapping> </element> <element id="ResearchStudy.contact"> <path value="ResearchStudy.contact" /> <short value="Contact details for the study" /> <definition value="Contact details to assist a user in learning more about or engaging with the study." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.contact" /> <min value="0" /> <max value="*" /> </base> <type> <code value="ContactDetail" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators" /> </mapping> </element> <element id="ResearchStudy.relatedArtifact"> <path value="ResearchStudy.relatedArtifact" /> <short value="References and dependencies" /> <definition value="Citations, references and other related documents." /> <comment value="Each related artifact is either an attachment, or a reference to another knowledge resource, but not both." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.relatedArtifact" /> <min value="0" /> <max value="*" /> </base> <type> <code value="RelatedArtifact" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Citations, Links, Available Study Data/Documents" /> </mapping> </element> <element id="ResearchStudy.keyword"> <path value="ResearchStudy.keyword" /> <short value="Used to search for the study" /> <definition value="Key terms to aid in searching for or filtering the study." /> <comment value="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." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.keyword" /> <min value="0" /> <max value="*" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyKeyword" /> </extension> <strength value="example" /> <description value="Words associated with the study that may be useful in discovery" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Keywords" /> </mapping> </element> <element id="ResearchStudy.jurisdiction"> <path value="ResearchStudy.jurisdiction" /> <short value="Geographic region(s) for study" /> <definition value="Indicates a country, state or other region where the study is taking place." /> <comment value="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." /> <min value="1" /> <max value="1" /> <base> <path value="ResearchStudy.jurisdiction" /> <min value="0" /> <max value="*" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="required" /> <description value="Countries and regions within which this artifact is targeted for use" /> <valueSetUri value="http://uk-koeln.de/fhir/ValueSet/clinical-site/rechtsgrundlage" /> </binding> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.id"> <path value="ResearchStudy.jurisdiction.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.extension"> <path value="ResearchStudy.jurisdiction.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding"> <path value="ResearchStudy.jurisdiction.coding" /> <short value="Code defined by a terminology system" /> <definition value="A reference to a code defined by a terminology system." /> <comment value="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." /> <requirements value="Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings." /> <min value="1" /> <max value="1" /> <base> <path value="CodeableConcept.coding" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Coding" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE subset one of the sets of component 1-3 or 4-6" /> </mapping> <mapping> <identity value="rim" /> <map value="CV" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:Coding rdfs:subClassOf dt:CDCoding" /> </mapping> <mapping> <identity value="v2" /> <map value="C*E.1-8, C*E.10-22" /> </mapping> <mapping> <identity value="rim" /> <map value="union(., ./translation)" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.id"> <path value="ResearchStudy.jurisdiction.coding.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.extension"> <path value="ResearchStudy.jurisdiction.coding.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.system"> <path value="ResearchStudy.jurisdiction.coding.system" /> <short value="Identity of the terminology system" /> <definition value="The identification of the code system that defines the meaning of the symbol in the code." /> <comment value="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." /> <requirements value="Need to be unambiguous about the source of the definition of the symbol." /> <min value="1" /> <max value="1" /> <base> <path value="Coding.system" /> <min value="0" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="C*E.3" /> </mapping> <mapping> <identity value="rim" /> <map value="./codeSystem" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.version"> <path value="ResearchStudy.jurisdiction.coding.version" /> <short value="Version of the system - if relevant" /> <definition value="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." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="Coding.version" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="C*E.7" /> </mapping> <mapping> <identity value="rim" /> <map value="./codeSystemVersion" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.code"> <path value="ResearchStudy.jurisdiction.coding.code" /> <short value="Symbol in syntax defined by the system" /> <definition value="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)." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <requirements value="Need to refer to a particular code in the system." /> <min value="1" /> <max value="1" /> <base> <path value="Coding.code" /> <min value="0" /> <max value="1" /> </base> <type> <code value="code" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="C*E.1" /> </mapping> <mapping> <identity value="rim" /> <map value="./code" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.display"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true" /> </extension> <path value="ResearchStudy.jurisdiction.coding.display" /> <short value="Representation defined by the system" /> <definition value="A representation of the meaning of the code in the system, following the rules of the system." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know the system." /> <min value="0" /> <max value="1" /> <base> <path value="Coding.display" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="C*E.2 - but note this is not well followed" /> </mapping> <mapping> <identity value="rim" /> <map value="CV.displayName" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.coding.userSelected"> <path value="ResearchStudy.jurisdiction.coding.userSelected" /> <short value="If this coding was chosen directly by the user" /> <definition value="Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays)." /> <comment value="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." /> <requirements value="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 value="0" /> <max value="1" /> <base> <path value="Coding.userSelected" /> <min value="0" /> <max value="1" /> </base> <type> <code value="boolean" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="Sometimes implied by being first" /> </mapping> <mapping> <identity value="rim" /> <map value="CD.codingRationale" /> </mapping> <mapping> <identity value="orim" /> <map value="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 ]" /> </mapping> </element> <element id="ResearchStudy.jurisdiction.text"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true" /> </extension> <path value="ResearchStudy.jurisdiction.text" /> <short value="Plain text representation of the concept" /> <definition value="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." /> <comment value="Very often the text is the same as a displayName of one of the codings." /> <requirements value="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 value="0" /> <max value="1" /> <base> <path value="CodeableConcept.text" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="C*E.9. But note many systems use C*E.2 for this" /> </mapping> <mapping> <identity value="rim" /> <map value="./originalText[mediaType/code="text/plain"]/data" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText" /> </mapping> </element> <element id="ResearchStudy.description"> <path value="ResearchStudy.description" /> <short value="What this is study doing" /> <definition value="A full description of how the study is being conducted." /> <comment value="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)" /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.description" /> <min value="0" /> <max value="1" /> </base> <type> <code value="markdown" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Detailed Description" /> </mapping> </element> <element id="ResearchStudy.description.id"> <path value="ResearchStudy.description.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.description.extension"> <path value="ResearchStudy.description.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.description.extension:description-en"> <path value="ResearchStudy.description.extension" /> <sliceName value="description-en" /> <short value="Optional Extensions Element" /> <definition value="Optional Extension Element - found in all resources." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="1" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> <profile value="http://uk-koeln.de/fhir/StructureDefinition/Extension/clinical-site/researchstudy-description-en" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mustSupport value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.description.extension:description-en.id"> <path value="ResearchStudy.description.extension.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.description.extension:description-en.extension"> <path value="ResearchStudy.description.extension.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.description.extension:description-en.url"> <path value="ResearchStudy.description.extension.url" /> <representation value="xmlAttr" /> <short value="identifies the meaning of the extension" /> <definition value="Source of the definition for the extension code - a logical name or a URL." /> <comment value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension." /> <min value="1" /> <max value="1" /> <base> <path value="Extension.url" /> <min value="1" /> <max value="1" /> </base> <type> <code value="uri" /> </type> <fixedUri value="http://uk-koeln.de/fhir/StructureDefinition/Extension/clinical-site/researchstudy-description-en" /> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.description.extension:description-en.valueMarkdown:valueMarkdown"> <path value="ResearchStudy.description.extension.valueMarkdown" /> <sliceName value="valueMarkdown" /> <short value="Value of extension" /> <definition value="Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list)." /> <comment value="A stream of bytes, base64 encoded" /> <min value="1" /> <max value="1" /> <base> <path value="Extension.value[x]" /> <min value="0" /> <max value="1" /> </base> <type> <code value="markdown" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mustSupport value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.description.value"> <path value="ResearchStudy.description.value" /> <representation value="xmlAttr" /> <short value="Primitive value for markdown" /> <definition value="Primitive value for markdown" /> <min value="0" /> <max value="1" /> <base> <path value="string.value" /> <min value="0" /> <max value="1" /> </base> <type> <code> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-json-type"> <valueString value="string" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-xml-type"> <valueString value="xsd:string" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-rdf-type"> <valueString value="xsd:string" /> </extension> </code> </type> <maxLength value="1048576" /> </element> <element id="ResearchStudy.enrollment"> <path value="ResearchStudy.enrollment" /> <short value="Inclusion & exclusion criteria" /> <definition value="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"." /> <comment value="The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource." /> <alias value="patient" /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.enrollment" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)" /> </mapping> <mapping> <identity value="w5" /> <map value="who.focus" /> </mapping> </element> <element id="ResearchStudy.period"> <path value="ResearchStudy.period" /> <short value="When the study began and ended" /> <definition value="Identifies the start date and the expected (or actual, depending on status) end date for the study." /> <comment value="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." /> <requirements value="[The list of types may be constrained as appropriate for the type of event]." /> <alias value="timing" /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.period" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Period" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="per-1" /> <severity value="error" /> <human value="If present, start SHALL have a lower value than end" /> <expression value="start.empty() or end.empty() or (start <= end)" /> <xpath value="not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="DR" /> </mapping> <mapping> <identity value="rim" /> <map value="IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Study Start Date (start); Study Completion Date (end)" /> </mapping> <mapping> <identity value="w5" /> <map value="when.done" /> </mapping> </element> <element id="ResearchStudy.sponsor"> <path value="ResearchStudy.sponsor" /> <short value="Organization responsible for the study" /> <definition value="The organization responsible for the execution of the study." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.sponsor" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://uk-koeln.de/fhir/StructureDefinition/Organization/clinical-site" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Sponsor" /> </mapping> <mapping> <identity value="w5" /> <map value="who.actor" /> </mapping> </element> <element id="ResearchStudy.principalInvestigator"> <path value="ResearchStudy.principalInvestigator" /> <short value="The individual responsible for the study" /> <definition value="Indicates the individual who has primary oversite of the execution of the study." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.principalInvestigator" /> <min value="0" /> <max value="1" /> </base> <type> <code value="Reference" /> <targetProfile value="http://uk-koeln.de/fhir/StructureDefinition/Practitioner/clinical-site" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <mustSupport value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Principal Investigator" /> </mapping> <mapping> <identity value="w5" /> <map value="who.actor" /> </mapping> </element> <element id="ResearchStudy.site"> <path value="ResearchStudy.site" /> <short value="Location involved in study execution" /> <definition value="Clinic, hospital or other healthcare location that is participating in the study." /> <comment value="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." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.site" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ref-1" /> <severity value="error" /> <human value="SHALL have a contained resource if a local reference is provided" /> <expression value="reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))" /> <xpath value="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, '#')])" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="The target of a resource reference is a RIM entry point (Act, Role, or Entity)" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Facility" /> </mapping> <mapping> <identity value="w5" /> <map value="where" /> </mapping> </element> <element id="ResearchStudy.reasonStopped"> <path value="ResearchStudy.reasonStopped" /> <short value="Reason for terminating study early" /> <definition value="A description and/or code explaining the premature termination of the study." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.reasonStopped" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Why Study Stopped" /> </mapping> <mapping> <identity value="w5" /> <map value="why" /> </mapping> </element> <element id="ResearchStudy.note"> <path value="ResearchStudy.note" /> <short value="Comments made about the event" /> <definition value="Comments made about the event by the performer, subject or other participants." /> <comment value="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)." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.note" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Annotation" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="N/A" /> </mapping> <mapping> <identity value="rim" /> <map value="Act" /> </mapping> </element> <element id="ResearchStudy.arm"> <path value="ResearchStudy.arm" /> <short value="Defined path through the study for a subject" /> <definition value="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." /> <min value="0" /> <max value="*" /> <base> <path value="ResearchStudy.arm" /> <min value="0" /> <max value="*" /> </base> <type> <code value="BackboneElement" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Arms" /> </mapping> </element> <element id="ResearchStudy.arm.id"> <path value="ResearchStudy.arm.id" /> <representation value="xmlAttr" /> <short value="xml:id (or equivalent in JSON)" /> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="Element.id" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> </element> <element id="ResearchStudy.arm.extension"> <path value="ResearchStudy.arm.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <description value="Extensions are always sliced by (at least) url" /> <rules value="open" /> </slicing> <short value="Additional Content defined by implementations" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <min value="0" /> <max value="*" /> <base> <path value="Element.extension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.arm.modifierExtension"> <path value="ResearchStudy.arm.modifierExtension" /> <short value="Extensions that cannot be ignored" /> <definition value="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." /> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone." /> <alias value="extensions" /> <alias value="user content" /> <alias value="modifiers" /> <min value="0" /> <max value="*" /> <base> <path value="BackboneElement.modifierExtension" /> <min value="0" /> <max value="*" /> </base> <type> <code value="Extension" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <constraint> <key value="ext-1" /> <severity value="error" /> <human value="Must have either extensions or value[x], not both" /> <expression value="extension.exists() != value.exists()" /> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])" /> </constraint> <isModifier value="true" /> <isSummary value="true" /> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="rim" /> <map value="N/A" /> </mapping> </element> <element id="ResearchStudy.arm.name"> <path value="ResearchStudy.arm.name" /> <short value="Label for study arm" /> <definition value="Unique, human-readable label for this arm of the study." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="1" /> <max value="1" /> <base> <path value="ResearchStudy.arm.name" /> <min value="1" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Arm Label" /> </mapping> </element> <element id="ResearchStudy.arm.code"> <path value="ResearchStudy.arm.code" /> <short value="Categorization of study arm" /> <definition value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater." /> <comment value="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." /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.arm.code" /> <min value="0" /> <max value="1" /> </base> <type> <code value="CodeableConcept" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="v2" /> <map value="CE/CNE/CWE" /> </mapping> <mapping> <identity value="rim" /> <map value="CD" /> </mapping> <mapping> <identity value="orim" /> <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Arm Type" /> </mapping> </element> <element id="ResearchStudy.arm.description"> <path value="ResearchStudy.arm.description" /> <short value="Short explanation of study path" /> <definition value="A succinct description of the path through the study that would be followed by a subject adhering to this arm." /> <comment value="Note that FHIR strings may not exceed 1MB in size" /> <min value="0" /> <max value="1" /> <base> <path value="ResearchStudy.arm.description" /> <min value="0" /> <max value="1" /> </base> <type> <code value="string" /> </type> <condition value="ele-1" /> <constraint> <key value="ele-1" /> <severity value="error" /> <human value="All FHIR elements must have a @value or children" /> <expression value="hasValue() | (children().count() > id.count())" /> <xpath value="@value|f:*|h:div" /> </constraint> <mapping> <identity value="rim" /> <map value="n/a" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <map value="Arm Description" /> </mapping> </element> </snapshot> <differential> <element id="ResearchStudy.identifier"> <path value="ResearchStudy.identifier" /> <slicing> <discriminator> <type value="value" /> <path value="system" /> </discriminator> <rules value="closed" /> </slicing> <min value="3" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:pruefplancode"> <path value="ResearchStudy.identifier" /> <sliceName value="pruefplancode" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:pruefplancode.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/pruefplancode" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:pruefplancode.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:eudraCtNr"> <path value="ResearchStudy.identifier" /> <sliceName value="eudraCtNr" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:eudraCtNr.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/eudraCtNr" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:eudraCtNr.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:nummerEthikkommission"> <path value="ResearchStudy.identifier" /> <sliceName value="nummerEthikkommission" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/nummerEthikkommission" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:nummerEthikkommission.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:nummerKoeln"> <path value="ResearchStudy.identifier" /> <sliceName value="nummerKoeln" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:nummerKoeln.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/nummerKoeln" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:nummerKoeln.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:isrctn"> <path value="ResearchStudy.identifier" /> <sliceName value="isrctn" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:isrctn.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/isrctn" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:isrctn.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov"> <path value="ResearchStudy.identifier" /> <sliceName value="clinicaltrialsGov" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/clinicaltrialsGov" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:clinicaltrialsGov.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:drks"> <path value="ResearchStudy.identifier" /> <sliceName value="drks" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:drks.system"> <path value="ResearchStudy.identifier.system" /> <min value="1" /> <fixedUri value="http://uk-koeln.de/fhir/identifiers/drks" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.identifier:drks.value"> <path value="ResearchStudy.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.title"> <path value="ResearchStudy.title" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.status"> <path value="ResearchStudy.status" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.jurisdiction"> <path value="ResearchStudy.jurisdiction" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction" /> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true" /> </extension> <strength value="required" /> <valueSetUri value="http://uk-koeln.de/fhir/ValueSet/clinical-site/rechtsgrundlage" /> </binding> </element> <element id="ResearchStudy.jurisdiction.coding"> <path value="ResearchStudy.jurisdiction.coding" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.jurisdiction.coding.system"> <path value="ResearchStudy.jurisdiction.coding.system" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.jurisdiction.coding.code"> <path value="ResearchStudy.jurisdiction.coding.code" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.description"> <path value="ResearchStudy.description" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.description.extension"> <path value="ResearchStudy.description.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="ResearchStudy.description.extension:description-en"> <path value="ResearchStudy.description.extension" /> <sliceName value="description-en" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="http://uk-koeln.de/fhir/StructureDefinition/Extension/clinical-site/researchstudy-description-en" /> </type> <mustSupport value="true" /> </element> <element id="ResearchStudy.description.extension:description-en.valueMarkdown:valueMarkdown"> <path value="ResearchStudy.description.extension.valueMarkdown" /> <sliceName value="valueMarkdown" /> <mustSupport value="true" /> </element> <element id="ResearchStudy.sponsor"> <path value="ResearchStudy.sponsor" /> <type> <code value="Reference" /> <targetProfile value="http://uk-koeln.de/fhir/StructureDefinition/Organization/clinical-site" /> </type> <mustSupport value="true" /> </element> <element id="ResearchStudy.principalInvestigator"> <path value="ResearchStudy.principalInvestigator" /> <type> <code value="Reference" /> <targetProfile value="http://uk-koeln.de/fhir/StructureDefinition/Practitioner/clinical-site" /> </type> <mustSupport value="true" /> </element> </differential> </StructureDefinition>