Logical Models

The following logical models are based on the current metadata schema version 3.3 as presented in our ART-DECOR project.

They do not take into account any mapping to FHIR.

General MDS modules

Core

NFDI4Health_LM_MDS_Core (nfdi4health-lm-mds-core)			Element	Element id nfdi4health-lm-mds-core Short description NFDI4Health Core Metadataschema Definition NFDI4Health Logical Model of Core V3.3.1 Data type Element Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
Resource		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource Short description Resource Definition Group of items providing information about a resource. Resources can be, for example, files or parts of them (e.g. datasets or study documents such as study protocols or questionnaires) or also studies or substudies. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.identifier Short description identifier Definition Unique identifier of the resource used for identification within the NFDI4Health. Comments Additional information: The identifier is assigned automatically. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
classification		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.classification Short description Resource classification Definition Group of items providing information about the classification of the resource within the predefined categories. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.classification.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.classification.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.classification.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
type		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.classification.type Short description Type of the resource Definition A term describing the resource. Comments Additional information: The selected resource type determines which information will be asked next. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Resource_Type_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
typeGeneral		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.classification.typeGeneral Short description In what form is the [RESOURCE] available? Definition Specific information about the form in which the [RESOURCE] is available. Comments Additional information: If the [RESOURCE] consists primarily of words for reading and is not covered by another textual resource type in this list, 'Text' should be used instead of 'Other'. 1..1, if Resource.classification.type != ("Study" OR "Substudy" OR "Dataset" OR "Registry" OR "Secondary data source") 0..0, if Resource.classification.type == ("Study" OR "Substudy" OR "Dataset" OR "Registry" OR "Secondary data source") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Resource_Type_General_NCI_MSH_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
titles		1..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.titles Short description Titles/names Definition Group of items providing information about title(s)/name(s) of the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.titles.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.titles.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.titles.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
text		1..1	string	Element id nfdi4health-lm-mds-core.Resource.titles.text Short description Title/name Definition Scientific unabbreviated title or name of the [RESOURCE]. Comments Additional information: If no official title/name has been defined yet, a title/name that is suitable for public display should be used. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.titles.language Short description Language of the title/name Definition Language in which the title/name is provided. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Languages_ISO (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
acronyms		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.acronyms Short description Acronyms Definition Group of items providing information about acronym(s) or alternative short title(s)/name(s) of the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.acronyms.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.acronyms.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.acronyms.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
text		1..1	string	Element id nfdi4health-lm-mds-core.Resource.acronyms.text Short description Acronym Definition If existing, acronym(s) of the [RESOURCE]. Comments Additional information: The field refers primarily to resources which have an acronym. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.acronyms.language Short description Language of the acronym Definition Language in which the acronym is provided. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Languages_ISO (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
descriptions		1..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.descriptions Short description Descriptions Definition Group of items providing information about the description(s) of the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.descriptions.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.descriptions.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.descriptions.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
text		1..1	string	Element id nfdi4health-lm-mds-core.Resource.descriptions.text Short description Description Definition Short plain text summary of the [RESOURCE]. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.descriptions.language Short description Language of the description Definition Language in which the description text is provided. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Languages_ISO (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
keywords		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.keywords Short description Keywords Definition Group of items providing information about keywords describing the [RESOURCE]. Comments Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.keywords.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.keywords.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.keywords.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-core.Resource.keywords.label Short description Keyword Definition Keyword(s) describing the [RESOURCE]. Comments Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH, UMLS) is preferred. However, also self-assigned keywords are allowed. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example SARS-CoV-2
code		0..1	string	Element id nfdi4health-lm-mds-core.Resource.keywords.code Short description Code of the keyword Definition If known, the code of the keyword in the classification/vocabulary used. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example http://id.nlm.nih.gov/mesh/D000086402
languages		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.languages Short description Languages Definition Language(s) in which the [RESOURCE] is conducted/provided. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Languages_ISO (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
webpage		0..1	string	Element id nfdi4health-lm-mds-core.Resource.webpage Short description Web page Definition If existing, a link to the web page directly relevant to the [RESOURCE]. Comments Additional information: Other web pages related to the [RESOURCE] can additionally be entered in the section 'Related resources'. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
nonStudyDetails		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails Short description Further details Definition Group of items providing further detailed information about the [RESOURCE]. It is applicable only to resource types other than a study, a substudy, a dataset, a registry, or a secondary data source. Comments Cardinality: 1..1, if Resource.classification.type != ("Study" OR "Substudy" OR "Registry" OR "Secondary data source") 0..0, if Resource.classification.type == ("Study" OR "Substudy" OR "Registry" OR "Secondary data source") Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
version		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.version Short description Version Definition If applicable, the version number of the [RESOURCE]. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
format		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.format Short description Format Definition If applicable, the file format of the [RESOURCE] (e.g., XML, PDF, XLSX, etc.). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example PDF
useRights		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights Short description Use rights Definition Group of items providing information about the rights to (re-)use the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
label		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.label Short description License Definition License defining the rights to (re-)use the [RESOURCE]. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Use_Rights_Label_SPDX_SNOMED_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
link		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.link Short description URL of the license Definition Link to a web page that contains detailed information about the selected license. Comments Cardinality: 0..1, if Resource.nonStudyDetails.useRights.label == "Other" 0..0, if Resource.nonStudyDetails.useRights.label != "Other" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
confirmations		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations Short description Licensing confirmations Definition Group of items applicable only if a Creative Commons (CC) license is selected. Comments Additional information: In order to successfully publish the [RESOURCE] under the respective license, all four questions ought to be confirmed.Cardinality: 1..1, if Resource.nonStudyDetails.useRights.label != ("CC0 1.0 (Creative Commons Zero v1.0 Universal)" OR "All rights reserved" OR "Other" OR "Not applicable" OR "Unknown") 0..0, if Resource.nonStudyDetails.useRights.label == ("CC0 1.0 (Creative Commons Zero v1.0 Universal)" OR "All rights reserved" OR "Other" OR "Not applicable" OR "Unknown") Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
authority		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.authority Short description Do you confirm that the authors of the [RESOURCE] have authority to license it? Definition Confirmation that the authors of the [RESOURCE] have authority to license it. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
terms		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.terms Short description Do you confirm that the authors of the [RESOURCE] have read and understood the terms of the chosen license? Definition Confirmation that the authors of the [RESOURCE] have read and understood the terms of the chosen license. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
irrevocability		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.irrevocability Short description Do you confirm that the authors of the [RESOURCE] understand that Creative Commons licensing is irrevocable? Definition Confirmation that the authors of the [RESOURCE] understand that Creative Commons (CC) licensing is not revocable. Comments Additional information: The [RESOURCE] can be licensed using a CC-license only if it is free of the third-party rights. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
supportByLicensing		1..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.confirmations.supportByLicensing Short description Do you confirm that the authors of the [RESOURCE] allow NFDI4Health to license the document? Definition Confirmation that NFDI4Health is allowed to license the document, i.e. to add the license information such as a license button and a statement that your material is licensed under a Creative Commons license to the [RESOURCE]. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
description		0..1	string	Element id nfdi4health-lm-mds-core.Resource.nonStudyDetails.useRights.description Short description Additional information about use rights Definition Any additional descriptive information explaining terms and conditions to (re-)use the [RESOURCE]. Comments Additional information: If 'Other' is selected in the field 'License', the preferred license or terms and conditions for (re-)use should be specified here. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
contributors		1..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors Short description Contributors Definition Group of items providing information about person(s), group(s) of persons or institution(s)/organisation(s) contributing to the [RESOURCE]. Comments Additional information: For each [RESOURCE], there may be multiple contributors, but at least one person, group of persons or institution/organisation must be specified. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
nameType		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.nameType Short description Is it a personal or organisational contribution? Definition Indication whether the contribution was made by person(s) or organisation(s)/institution(s)/group(s). Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Role_Name_Type_SNOMED (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
organisational		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational Short description Details about the contributing organisations/institutions/groups Definition Group of items providing information about organisation(s), institution(s) or group(s) of persons contributing to the [RESOURCE]. Comments Additional information: Group of items applicable only when providing organisational, institutional or group names. 1..1, if Resource.contributors.nameType == "Organisational" 0..0, if Resource.contributors.nameType != "Organisational" Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
type		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.type Short description Contributor type Definition The type of role that an organization, institution, or group of persons fulfills as a contributor. For example, this could include being a sponsor of the study or a group of authors of the document. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Organisational_Roles_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
fundingIds		0..*	string	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.fundingIds Short description Funding identifiers Definition Identifier(s) assigned by a funder to the [RESOURCE]. Comments Cardinality: 0.., if Resource.contributors.organisational.type == ("Funder (public)" OR "Funder (private)") 0..0, if Resource.contributors.organisational.type != ("Funder (public)" OR "Funder (private)") Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
name		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.organisational.name Short description Name of the organisation/institution/group Definition Name of the contributing organisation, institution or group. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
personal		0..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.personal Short description Details about the contributing persons Definition Group of items providing information about person(s) contributing to the [RESOURCE]. Comments Additional information: Group of items applicable only when providing person names. 1..1, if Resource.contributors.nameType == "Personal" 0..0, if Resource.contributors.nameType != "Personal" Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
type		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.type Short description Contributor type Definition The type of role that a person fulfills as a contributor. For example, this could include being a principal investigator of the study or an author of the document. Comments (1) A person taking responsibility for and initiating a study; (2) An individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the study design meets appropriate standards and to ensure appropriate conduct and reporting). In commercial trials, the primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder [CT.gov (<a href="https://prsinfo.clinicaltrials.gov/definitions.html" rel="noopener noreferrer nofollow">https://prsinfo.clinicaltrials.gov/definitions.html</a>, <a href="https://www.clinicaltrials.gov/ct2/about-studies/glossary" rel="noopener noreferrer nofollow">https://www.clinicaltrials.gov/ct2/about-studies/glossary</a>), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Personal_Roles_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
givenName		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.givenName Short description Given name Definition Given name of the person. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
familyName		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.familyName Short description Family name Definition Family name(s) of the person. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
identifiers		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers Short description Digital identifiers Definition Group of items providing information about digital identifiers of the person. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.identifier Short description Identifier Definition Digital identifier according to a specific scheme that uniquely identifies the person. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example 0000-0003-1379-7023
scheme		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.personal.identifiers.scheme Short description Scheme Definition Type of the identifier scheme. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Role_Name_Identifier_Scheme_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example { "coding": [ { "system": "urn:oid:2.16.840.1.113883.3.1937.777.64.5.1", "code": "080", "display": "ORCID" } ], "text": "ORCID" } Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
email		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.email Short description Email address Definition Email address of the person, organisation, institution or group of persons. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
phone		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.phone Short description Phone number Definition Phone number of the person, organisation, institution or group of persons. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example +49 (0)153 1112233
affiliations		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations Short description Organisations associated with the contributor Definition Group of items providing further information about the organisation(s) associated with the contributor. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.name Short description Name Definition Name of the organisation associated with the contributor. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
address		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.address Short description Address Definition Address of the organisation associated with the contributor. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example Gleueler Straße 60, 50931, Cologne, Germany
webpage		0..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.webpage Short description Web page Definition Web page of the organisation associated with the contributor. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
identifiers		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers Short description Digital identifiers Definition Group of items providing information about digital identifiers of the organisation associated with the contributor. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.identifier Short description Identifier Definition Digital identifier according to a specific scheme that uniquely identifies the organisation. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example 0259fwx54
scheme		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.contributors.affiliations.identifiers.scheme Short description Scheme Definition Type of the identifier scheme. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Role_Affiliation_Identifier_Scheme_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
idsAlternative		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.idsAlternative Short description Alternative identifiers Definition Group of items providing information about identifiers (IDs) assigned to the given [RESOURCE] by another registering systems, e.g. a registry of clinical trials or a data repository. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsAlternative.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsAlternative.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsAlternative.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
schemes		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.idsAlternative.schemes Short description Type of the registry Definition Type/name of the system where the given [RESOURCE] is already registered. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_ID_TYPE_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.idsAlternative.identifier Short description Identifier Definition Identifier assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example ISRCTN91495258
ids		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.ids Short description Related resources Definition Group of items providing information about the resources related to the given [RESOURCE] and their identifiers (IDs), e.g. DOIs of publications, datasets, study documents or links to web pages. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.ids.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.ids.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.ids.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifier		1..1	string	Element id nfdi4health-lm-mds-core.Resource.ids.identifier Short description Identifier of the related resource Definition Identifier related to, or associated with, the [RESOURCE] being registered. These can be identifiers of related publications, datasets, study documents, links to web pages, etc. Comments Additional information: a) Publications like journal articles usually have a DOI, e.g. 10.3238/arztebl.2020.0861. b) A link (URL) starting with 'http(s)://' to a web page with any additional information can also be provided. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example 10.4126/FRL01-006431467
schemes		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.ids.schemes Short description Type of the identifier Definition Type of the identifier of the related resource. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Identifier_Type_Related_Artifact_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example { "text": "DOI" } Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
relationType		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.ids.relationType Short description Relationship between the resources Definition Relationship between the [RESOURCE] being registered (A) and the related resource (B). Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Relation_Type_Ids_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example { "coding": [ { "system": "urn:oid:2.16.840.1.113883.3.1937.777.64.5.1", "code": "065", "display": "A is part of B" } ], "text": "A is part of B" } Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
typeGeneral		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.ids.typeGeneral Short description Type of the related resource Definition Type/form of the related resource, e.g. journal article, dataset, text, etc. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Resource_Type_General_NCI_MSH_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
idsNfdi4health		0..*	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health Short description Related resources registered on this portal Definition Group of items providing information about related resources (e.g. studies, study documents, etc.) registered on this portal. Comments Additional information: Does the [RESOURCE] have any related resources registered on this portal? Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
identifiers		1..1	string	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.identifiers Short description Identifier of the related resource Definition Identifier of the related resource assigned on this portal. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example 39
date		0..1	date	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.date Short description Date of identifier assignment Definition Date when the identifier of the related resource was assigned. Comments Additional information: Preferred date format: DD.MM.YYYY. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
relationType		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.idsNfdi4health.relationType Short description Relationship between the resources Definition Relationship between the [RESOURCE] being registered (A) and the related resource (B). Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Relation_Type_Ids_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
nutritionalData		0..1	boolean	Element id nfdi4health-lm-mds-core.Resource.nutritionalData Short description Nutritional data collected? Definition Indication whether the [RESOURCE] collects nutritional data. Comments Cardinality: 1..1, if Resource.classification.type == ("Study" OR "Substudy") AND Resource.provenance.dataSource == "Manually collected" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Resource.provenance.dataSource != "Manually collected" Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
chronicDiseases		0..1	boolean	Element id nfdi4health-lm-mds-core.Resource.chronicDiseases Short description Chronic diseases included? Definition Indication whether the [RESOURCE] addresses chronic diseases. Comments Cardinality: 1..1, if Resource.provenance.dataSource == "Manually collected" 0..0, if Resource.provenance.dataSource != "Manually collected" Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
provenance		1..1	BackboneElement	Element id nfdi4health-lm-mds-core.Resource.provenance Short description Provenance aspects of data entry Definition Group of items providing information about provenance aspects of the data entry on this portal. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.provenance.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.provenance.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-core.Resource.provenance.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
dataSource		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-core.Resource.provenance.dataSource Short description Source of information Definition Source of information about the [RESOURCE] and the way it was uploaded/collected. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Provenance_Data_Source_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
verificationDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.verificationDate Short description Last verified on Definition Date on which the responsible party last verified the information about the [RESOURCE], even if no additional or updated information is being submitted. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
verificationUser		0..1	CodeableConcept	Element id nfdi4health-lm-mds-core.Resource.provenance.verificationUser Short description Last verified by Definition User who last verified the information about the [RESOURCE]. Comments 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. Data type CodeableConcept Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
firstSubmittedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.firstSubmittedDate Short description First submitted on Definition Date when the [RESOURCE] was first submitted for publication. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
firstSubmittedUser		0..1	CodeableConcept	Element id nfdi4health-lm-mds-core.Resource.provenance.firstSubmittedUser Short description First submitted by Definition User who first submitted the [RESOURCE] for publication. Comments 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. Data type CodeableConcept Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
firstPostedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.firstPostedDate Short description First posted/published on Definition Date when the [RESOURCE] was first posted/published. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
firstPostedUser		0..1	CodeableConcept	Element id nfdi4health-lm-mds-core.Resource.provenance.firstPostedUser Short description First posted/published by Definition User who first posted/published the [RESOURCE]. Comments 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. Data type CodeableConcept Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
lastUpdateSubmittedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdateSubmittedDate Short description Last update submitted on Definition Date when the last update of the [RESOURCE] was submitted for publication. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
lastUpdateSubmittedUser		0..1	CodeableConcept	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdateSubmittedUser Short description Last updated submitted by Definition User who submitted the last update of the [RESOURCE]. Comments 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. Data type CodeableConcept Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
lastUpdatePostedDate		0..1	date	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdatePostedDate Short description Last update posted/published on Definition Date when the last update of the [RESOURCE] was posted/published. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
lastUpdatePostedUser		0..1	CodeableConcept	Element id nfdi4health-lm-mds-core.Resource.provenance.lastUpdatePostedUser Short description Last update posted/published by Definition User who posted/published the last update of the [RESOURCE]. Comments 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. Data type CodeableConcept Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
resourceVersion		0..1	string	Element id nfdi4health-lm-mds-core.Resource.provenance.resourceVersion Short description Version number Definition Version number of the [RESOURCE] within this portal. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`

Design

NFDI4Health_LM_MDS_Design (nfdi4health-lm-mds-design)			Element	Element id nfdi4health-lm-mds-design Short description NFDI4Health Module Design Definition NFDI4Health Logical Model of Module Design V3.3.1 Data type Element Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
Design		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design Short description Characteristics of the [RESOURCE] Definition Group of items relevant for studies, substudies, registries and/or secondary data sources, including details on targeted health conditions, study population, outcome measures, and study design. Comments Additional information: Group of items applicable only to studies, substudies, registries, and secondary data sources. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
primaryDesign		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.primaryDesign Short description Is the study design non-interventional or interventional? Definition Is the study design non-interventional or interventional? Comments Cardinality: 1..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Primary_Design_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
studyType		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.studyType Short description Information on specific study design Definition Group of items providing information about the study design. Comments Cardinality: 1..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.studyType.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.studyType.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.studyType.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
interventional		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.studyType.interventional Short description Interventional study model Definition The strategy for assigning interventions to participants. Comments Cardinality: 1.., if Design.primaryDesign == "Interventional" 0..0, if Design.primaryDesign != "Interventional" Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_Type_Interventional_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
nonInterventional		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.studyType.nonInterventional Short description Non-interventional study model Definition The primary strategy for participant identification and follow-up. Comments Cardinality: 1.., if Design.primaryDesign == "Non-interventional" 0..0, if Design.primaryDesign != "Non-interventional" Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_Type_Non_Interventional_NCI_MSH_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
conditions		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.conditions Short description Primary health conditions or diseases considered in the [RESOURCE] Definition Group of items providing information about primary health conditions or diseases considered in the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.conditions.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.conditions.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.conditions.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design.Design.conditions.label Short description Health condition or disease Definition The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks. Comments Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example SARS-CoV-2
classification		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.conditions.classification Short description Terminology/classification Definition Terminology/classification used to specify the health condition or disease. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Conditions_Classification_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example { "text": "SNOMED CT" } Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
code		0..1	string	Element id nfdi4health-lm-mds-design.Design.conditions.code Short description Code of the health condition or disease Definition Code of the health condition or disease in the terminology/classification. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example http://snomed.info/id/840533007
focus		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.focus Short description Primary focus of the [RESOURCE] Definition Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.focus.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.focus.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.focus.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design.Design.focus.label Short description Focus area Definition Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.). Comments Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
classification		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.focus.classification Short description Terminology/classification Definition Terminology/classification used for the focus area. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Conditions_Classification_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example { "text": "SNOMED CT" } Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
code		0..1	string	Element id nfdi4health-lm-mds-design.Design.focus.code Short description Code of the focus area Definition Code of the focus area in the terminology/classification. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example http://snomed.info/id/840533007
groupsOfDiseases		1..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.groupsOfDiseases Short description Groups of diseases or conditions Definition Group of items providing information about groups of diseases or conditions on which the data were collected in the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.groupsOfDiseases.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.groupsOfDiseases.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.groupsOfDiseases.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
generally		1..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.groupsOfDiseases.generally Short description Which groups of diseases or conditions were the data collected on? Definition General groups of diseases or conditions on which the data were collected. Comments Additional information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_ICD10_SCT (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
conditions		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.groupsOfDiseases.conditions Short description On which diseases or conditions were the data collected? Definition Diseases or conditions on which the data were collected in the [RESOURCE]. Comments Additional information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_Conditions_ICD (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
mortalityData		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.mortalityData Short description Mortality data collected? Definition Indication whether mortality data are collected in the [RESOURCE]. Comments Cardinality: 0..1, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.studyType.nonInterventional == ("Longitudinal" OR "Cohort" OR "Case-cohort" OR "Birth cohort" OR "Trend" OR "Panel")) OR Resource.classification.type == ("Registry" OR "Secondary data source") 0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND Design.studyType.nonInterventional != ("Longitudinal" OR "Cohort" OR "Case-cohort" OR "Birth cohort" OR "Trend" OR "Panel") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Mortality_Data_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
administrativeInformation		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.administrativeInformation Short description Administrative information Definition Group of items providing administrative information about the [RESOURCE]. Comments Cardinality: 1..1, if Resource.classification.type == ("Study" OR "Substudy") 0..1, if Resource.classification.type != ("Study" OR "Substudy") Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.administrativeInformation.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.administrativeInformation.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.administrativeInformation.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
ethicsCommitteeApproval		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.ethicsCommitteeApproval Short description Status of the ethics committee approval Definition Status of the request for approval from the (leading) ethics committee. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Ethics_Committee_Approval_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
status		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.status Short description Overall status Definition Overall status of the [RESOURCE]. Comments Additional information: If at least one study site in a multicenter study has the status 'Ongoing', then the overall status of the study must be 'Ongoing'. Cardinality: 1..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Overall_Status_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
statusWhenIntervention		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.statusWhenIntervention Short description Is the intervention ongoing or completed? Definition Is the intervention ongoing or completed? Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign == "Interventional" AND Design.administrativeInformation.status == ("At the planning stage" OR "Ongoing (I): Recruitment ongoing, but data collection not yet started" OR "Ongoing (II): Recruitment and data collection ongoing" OR "Ongoing (III): Recruitment completed, but data collection ongoing" OR "Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing") 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign != "Interventional" OR Design.administrativeInformation.status != ("At the planning stage" OR "Ongoing (I): Recruitment ongoing, but data collection not yet started" OR "Ongoing (II): Recruitment and data collection ongoing" OR "Ongoing (III): Recruitment completed, but data collection ongoing" OR "Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Status_When_Intervention_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
stageStopped		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.stageStopped Short description Stopping stage Definition Specification of the stage at which the [RESOURCE] was prematurely stopped. Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.administrativeInformation.status == ("Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume" OR "Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume") 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.administrativeInformation.status != ("Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume" OR "Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Status_Halted_Stage_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
reasonStopped		0..1	string	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.reasonStopped Short description Stopping reason Definition Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design. Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.administrativeInformation.status == ("Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume" OR "Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume") 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.administrativeInformation.status != ("Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume" OR "Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume") Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example accrual goal met
statusEnrollingByInvitation		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.statusEnrollingByInvitation Short description Participants enrolled by invitation? Definition Specification whether participants are selected from a predetermined population. Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
recruitmentStatusRegister		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.recruitmentStatusRegister Short description Overall recruitment status from the register of clinical trials Definition Overall recruitment status of the study as indicated in the corresponding register of clinical trials. Comments Additional information: The item applies only to studies automatically uploaded from the registers of clinical trials. 0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Resource.provenance.dataSource != "Manually collected" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Resource.provenance.dataSource == "Manually collected" Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Recruitment_Register_NCI_SCT_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
startDate		0..1	date	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.startDate Short description Start date Definition In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date. Comments Additional information: Preferred date format: DD.MM.YYYY. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
endDates		0..1	date	Element id nfdi4health-lm-mds-design.Design.administrativeInformation.endDates Short description End date Definition In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit. Comments Additional information: Preferred date format: DD.MM.YYYY. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
centers		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.centers Short description Mono- or multicentric? Definition Specification whether the data are collected at only one or at more than one study center. Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Centers_SNOMEDCT_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
centersNumber	C	0..1	Quantity	Element id nfdi4health-lm-mds-design.Design.centersNumber Short description Number of centers Definition Number of study centers involved in data collection. Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.centers == "Multicentric" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.centers != "Multicentric" Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
dataProviders		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataProviders Short description One or more data providers? Definition Specification whether the [RESOURCE] involves only one or more than one data provider. Comments Cardinality: 0..1, if Resource.classification.type == ("Registry" OR "Secondary data source") 0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Data_Providers_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
dataProvidersNumbers	C	0..1	Quantity	Element id nfdi4health-lm-mds-design.Design.dataProvidersNumbers Short description Number of data providers Definition Number of data providers involved in the [RESOURCE]. Comments Cardinality: 0..1, if Resource.classification.type == ("Registry" OR "Secondary data source") AND Design.dataProviders == "Several data providers" 0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") OR Design.dataProviders != "Several data providers" Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
subject		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.subject Short description Primary subject Definition The primary subject addressed by the [RESOURCE], for example persons, animals or other subject types. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Subject_SNOMEDCT (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
sampling		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.sampling Short description Sampling method Definition Group of items providing information about the applied sampling method. Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.sampling.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.sampling.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.sampling.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
method		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.sampling.method Short description Applied sampling method Definition Type of the sampling method applied for the selection of participants. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Sampling_Method_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
probabilityMethod		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.sampling.probabilityMethod Short description Specific type of probability sampling Definition Specific type of the probability sampling method applied for the selection of participants. Comments Cardinality: 0..1, if Design.sampling.method == "Probability" 0..0, if Design.sampling.method != "Probability" Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Sampling_Probability_Method_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
nonProbabilityMethod		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.sampling.nonProbabilityMethod Short description Specific type of non-probability sampling Definition Specific type of the non-probability sampling method applied for the selection of participants. Comments Cardinality: 0..1, if Design.sampling.method == "Non-probability" 0..0, if Design.sampling.method != "Non-probability" Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Sampling_Method_Non_Probability_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
dataSource		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.dataSource Short description Data sources of the [RESOURCE] Definition Group of items providing information about data sources from which the data of the [RESOURCE] are generated or extracted. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.dataSource.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.dataSource.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.dataSource.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
general		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSource.general Short description Types of data sources Definition Different types of data sources from which the data of the [RESOURCE] are generated or extracted. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Data_Sources_General_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
biosamples		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSource.biosamples Short description Biosamples collected Definition Specification of biosamples collected in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSource.general == "Biological samples" 0..0, if Design.dataSource.general != "Biological samples" Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_DS_Biosamples_SCT_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
imaging		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSource.imaging Short description Imaging data collected Definition Specification of imaging data collected in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSource.general == "Imaging data" 0..0, if Design.dataSource.general != "Imaging data" Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_Data_Sources_Imaging_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
omics		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSource.omics Short description Omics technologies used Definition Specification of omics technologies applied in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSource.general == "Omics technology" 0..0, if Design.dataSource.general != "Omics technology" Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_Data_Sources_Omics_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.dataSource.description Short description Additional information about data sources Definition If needed, additional descriptive information about the data sources of the [RESOURCE], for example indication of data sources not listed in the field 'Type(s) of data sources' or a more detailed description of the selected data sources. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
primaryPurpose		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.primaryPurpose Short description Primary purpose of the [RESOURCE] Definition Foremost for interventional studies, please specify the primary purpose why the study was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones. Comments Additional information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. 0..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Primary_Purpose_HL7_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
eligibilityCriteria		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria Short description Eligibility criteria Definition Group of items providing information about eligibility criteria for participants. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
ageMin		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMin Short description Eligibility criteria: Minimum age Definition Group of items providing information about the minimum eligible age of participants. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMin.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMin.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMin.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
number	C	1..1	Quantity	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMin.number Short description Minimum eligible age Definition Numerical value of the minimum age of potential participants eligible to participate in the [RESOURCE]. Comments Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'. Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
timeUnit		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMin.timeUnit Short description Unit of age Definition Unit of measurement used to describe the minimum eligible age. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
ageMax		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMax Short description Eligibility criteria: Maximum age Definition Group of items providing information about the maximum eligible age of participants. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMax.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMax.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMax.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
number	C	1..1	Quantity	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMax.number Short description Maximum eligible age Definition Numerical value of the maximum age of potential participants eligible to participate in the [RESOURCE]. Comments Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'. Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
timeUnit		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.ageMax.timeUnit Short description Unit of age Definition Unit of measurement used to describe the maximum eligible age. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
genders		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.genders Short description Eligible gender Definition Gender of potential participants eligible to participate in the [RESOURCE]. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Eligibility_Gender_SNOMEDCT_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
inclusionCriteria		0..1	string	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.inclusionCriteria Short description Inclusion criteria Definition Inclusion criteria for participation in the [RESOURCE]. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example - First inclusion criterion; - Second inclusion criterion;
exclusionCriteria		0..1	string	Element id nfdi4health-lm-mds-design.Design.eligibilityCriteria.exclusionCriteria Short description Exclusion criteria Definition Exclusion criteria for participation in the [RESOURCE]. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example - First inclusion criterion; - Second inclusion criterion;
population		1..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.population Short description Population of the [RESOURCE] Definition Group of items providing information about the population of the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.population.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.population.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.population.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
coverage		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.population.coverage Short description Coverage Definition Specification of the recruitment area of the [RESOURCE]. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Population_Coverage_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
countries		1..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.population.countries Short description Countries Definition Country or countries where the [RESOURCE] takes place. Comments 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. Data type CodeableConcept Binding http://hl7.org/fhir/ValueSet/country (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
region		0..1	string	Element id nfdi4health-lm-mds-design.Design.population.region Short description Regions and/or cities Definition If applicable, regions and/or cities within a country where the [RESOURCE] takes place. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.population.description Short description Population description Definition Additional descriptive information providing more details about the population of the [RESOURCE]. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
targetSampleSize	C	0..1	Quantity	Element id nfdi4health-lm-mds-design.Design.population.targetSampleSize Short description Target sample size Definition Intended number of observational units for the whole [RESOURCE] (for example intended number of participants at all sites). Comments Cardinality: 0..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
obtainedSampleSize	C	0..1	Quantity	Element id nfdi4health-lm-mds-design.Design.population.obtainedSampleSize Short description Obtained sample size Definition Obtained number of observational units for the whole [RESOURCE] (for example obtained number of participants at all sites). Comments Additional information: The value is only available after the end of recruitment. Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
hypotheses		0..*	string	Element id nfdi4health-lm-mds-design.Design.hypotheses Short description Research questions/hypotheses Definition Statement of the research questions and/or hypotheses underlying the [RESOURCE]. Comments Cardinality: 0.., if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
arms		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.arms Short description Arms of the study Definition Group of items providing information about the arms of the study. Comments Cardinality: 0.., if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign == "Interventional" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign != "Interventional" Data type* BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.arms.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.arms.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.arms.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design.Design.arms.label Short description Name of the arm Definition Short name used to identify the arm. Comments Additional information: 'Arm' means a pre-specified group or subgroup of participants in the [RESOURCE] assigned to receive specific intervention(s) (or no intervention) according to a protocol. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
type		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.arms.type Short description Role of the arm Definition Role of the given arm in the [RESOURCE]. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Arm_Group_Type_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.arms.description Short description Additional information about the arm Definition Additional descriptive information about the given arm. Comments Additional information: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the [RESOURCE]. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
groups		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.groups Short description Groups/cohorts of the [RESOURCE] Definition Group of items providing information about the groups/cohorts of the [RESOURCE]. Comments Cardinality: 0.., if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign == "Non-interventional" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign != "Non-interventional" Data type* BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.groups.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.groups.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.groups.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
label		1..1	string	Element id nfdi4health-lm-mds-design.Design.groups.label Short description Name of the group Definition Short name used to identify the group. Comments Additional information: 'Group' means a predefined group (cohort) of participants to be studied. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.groups.description Short description Additional information about the group Definition Additional descriptive information about the given group. Comments Additional information: Explanation of the nature of the group of participants (for example, participants with and without a condition, participants with and without an exposure, etc.). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
interventions		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.interventions Short description Interventions of the [RESOURCE] Definition Group of items providing information about the interventions of the [RESOURCE]. Comments Additional information: Specification of the intervention(s) associated with each arm. 0.., if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign == "Interventional" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign != "Interventional" Data type* BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventions.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventions.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventions.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		1..1	string	Element id nfdi4health-lm-mds-design.Design.interventions.name Short description Name of the intervention Definition A short descriptive name of the intervention. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
type		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.interventions.type Short description Type of the intervention Definition General type of the given intervention. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Intervention_Type_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.interventions.description Short description Additional information about the intervention Definition If needed, additional descriptive information about the given intervention. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
armsLabel		0..*	string	Element id nfdi4health-lm-mds-design.Design.interventions.armsLabel Short description Name(s) of the arm(s) associated with the given intervention Definition Name(s) of the arm(s) of the [RESOURCE] associated with the given intervention. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
exposures		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.exposures Short description Exposures Definition Group of items providing information about the exposures of the [RESOURCE]. Comments Additional information: Specification of the exposure(s) associated with each group. 0.., if (Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign == "Non-interventional") OR Resource.classification.type == ("Registry" OR "Secondary data source") 0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND Design.primaryDesign != "Non-interventional" Data type* BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.exposures.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.exposures.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.exposures.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
name		0..1	string	Element id nfdi4health-lm-mds-design.Design.exposures.name Short description Name of the exposure Definition A short descriptive name of the exposure. Comments Cardinality: 1..1, if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
type		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.exposures.type Short description type Definition General type of the given exposure. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Exposure_Type_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.exposures.description Short description Additional information about the exposure Definition If needed, additional descriptive information about the given exposure. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
groupsLabel		0..*	string	Element id nfdi4health-lm-mds-design.Design.exposures.groupsLabel Short description Name(s) of the group(s) associated with the given exposure Definition Name(s) of the group(s) of the [RESOURCE] associated with the given exposure. Comments Cardinality: 0.., if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
outcomes		0..*	BackboneElement	Element id nfdi4health-lm-mds-design.Design.outcomes Short description Outcome measures Definition Group of items providing information about outcome measures. Comments Additional information: The items are optional, especially for non-interventional studies. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.outcomes.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.outcomes.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.outcomes.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
title		1..1	string	Element id nfdi4health-lm-mds-design.Design.outcomes.title Short description Name of the outcome measure Definition Name of the outcome measure. For non-interventional studies, this can be the name of specific measurements or observations used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.outcomes.description Short description Description of the outcome measure Definition Additional descriptive information about the given outcome. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
type		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.outcomes.type Short description Type of the outcome measure Definition The type indicates the degree of importance of the outcome measure in the [RESOURCE]. Comments Cardinality: 1..1, if Design.outcomes.title != Null OR Design.outcomes.description != Null 0..0, if Design.outcomes.title == Null AND Design.outcomes.description == Null Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Outcome_Type_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
timeFrame		0..1	string	Element id nfdi4health-lm-mds-design.Design.outcomes.timeFrame Short description Time point(s) of assessment Definition Description of the time point(s) at which the measurement for the outcome is assessed, for example the specific duration of time over which each participant is assessed. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
comment		0..1	string	Element id nfdi4health-lm-mds-design.Design.comment Short description Additional information about the [RESOURCE] Definition Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
assessments		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.assessments Short description Additional assessments and measurements Definition Any additional assessments/measurements included in the [RESOURCE]. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Assessments_SCT_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
dataSharingPlan		1..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan Short description Data sharing Definition Group of items providing information regarding the sharing of data by the [RESOURCE]. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
generally		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.generally Short description Is it planned to share the data? Definition Indication whether there is a plan to make data collected in the [RESOURCE] available. In case of a [RESOURCE] with patients or other individuals, this refers to individual participant data (IPD). Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Yes_No_Undecided_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
supportingInformation		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.supportingInformation Short description Supporting documents available in addition to the data Definition Supporting information and documents which will be made available in addition to the data collected in the [RESOURCE]. Comments Cardinality: 0.., if Design.dataSharingPlan.generally == "Yes, there is a plan to make data available" 0..0, if Design.dataSharingPlan.generally != "Yes, there is a plan to make data available" Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Supporting_Information_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
timeFrame		0..1	string	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.timeFrame Short description When and for how long will the data be available? Definition Indication of the time period for which the data and, if applicable, supporting documents will be made available. Comments Cardinality: 0..1, if Design.dataSharingPlan.generally == "Yes, there is a plan to make data available" 0..0, if Design.dataSharingPlan.generally != "Yes, there is a plan to make data available" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
accessCriteria		0..1	string	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.accessCriteria Short description Criteria for data access Definition Indication of the access criteria by which the data will be shared, including: a) with whom; b) for which types of analyses; and c) by what mechanism. Comments Cardinality: 0..1, if Design.dataSharingPlan.generally == "Yes, there is a plan to make data available" 0..0, if Design.dataSharingPlan.generally != "Yes, there is a plan to make data available" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.description Short description Additional information about data sharing Definition Additional descriptive information providing more details about data sharing, for example indication of which data in particular will be shared or why the data will not be shared or why it is not yet decided. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
datashield		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.datashield Short description DataSHIELD/Opal infrastructure available? Definition Indication whether the DataSHIELD/Opal infrastructure is available. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Datashield_SCT_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
requestData		0..1	string	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.requestData Short description Link to data request application Definition If existing, a link to the web page where the data request form and/or information on data reuse can be found. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
url		0..1	string	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.url Short description Web page with additional information about data sharing Definition If existing, a link to the web page where additional information about data sharing can be found. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
recordLinkage		0..1	boolean	Element id nfdi4health-lm-mds-design.Design.dataSharingPlan.recordLinkage Short description Record linkage possible? Definition Indication if record linkage with other data sources is possible. Comments Additional information: Record linkage refers to the merging of data on the same person from different databases. 1..1, if Resource.provenance.dataSource == "Manually collected" 0..0, if Resource.provenance.dataSource != "Manually collected" Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
nonInterventional		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.nonInterventional Short description Non-interventional aspects of the [RESOURCE] Definition Group of items providing information about specific non-interventional aspects of the [RESOURCE]. Comments Additional information: Group of items applicable only to non-interventional resources. 0..1, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign == "Non-interventional") OR Resource.classification.type == ("Registry" OR "Secondary data source") 0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND Design.primaryDesign != "Non-interventional" Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.nonInterventional.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.nonInterventional.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.nonInterventional.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
timePerspectives		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.nonInterventional.timePerspectives Short description Temporal design Definition Temporal design of the study, i.e. the observation period in relation to the time of participant enrollment. Comments Cardinality: 0.., if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0 0.., if Resource.classification.type == ("Study" OR "Substudy") 0..0, if Resource.classification.type != ("Study" OR "Substudy") Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Time_Perspectives_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
targetFollowUpDuration		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration Short description Target follow-up duration Definition If applicable, anticipated time period over which each participant would be followed. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
number	C	1..1	Quantity	Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration.number Short description Target follow-up duration Definition Numerical value of the target follow-up duration. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
timeUnit		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration.timeUnit Short description Unit of time Definition Unit of measurement used to describe the follow-up duration. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Time_Units_UCUM (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
frequency	C	0..1	Quantity	Element id nfdi4health-lm-mds-design.Design.nonInterventional.targetFollowUpDuration.frequency Short description Number of follow-ups conducted Definition The number of follow-ups conducted within the specified duration. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
biospecimenRetention		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.nonInterventional.biospecimenRetention Short description Biosamples retained in a biorepository Definition Indication whether samples of biomaterials from participants are retained in a biorepository. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Biospecimen_Retention_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
biospecimenDescription		0..1	string	Element id nfdi4health-lm-mds-design.Design.nonInterventional.biospecimenDescription Short description Specific types of retained biosamples Definition Additional information about retained biosamples, i.e. an indication of the specific types of retained biospecimens (e.g. blood, serum, urine, etc.). Comments Cardinality: 0..1, if Design.nonInterventional.biospecimenRetention != "None retained" 0..0, if Design.nonInterventional.biospecimenRetention == "None retained" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples example blood
interventional		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.interventional Short description Interventional aspects of the [RESOURCE] Definition Group of items providing information about specific interventional aspects of the [RESOURCE]. Comments Additional information: Group of items applicable only to interventional resources. 0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign =="Interventional" 0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign !="Interventional" Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventional.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventional.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventional.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
phase		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.interventional.phase Short description Numerical phase Definition If applicable, numerical phase of the [RESOURCE]. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Phase_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
masking		0..1	BackboneElement	Element id nfdi4health-lm-mds-design.Design.interventional.masking Short description Masking of intervention(s) assignment Definition Group of items providing information about the masking of intervention(s) assignment. Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventional.masking.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventional.masking.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-design.Design.interventional.masking.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
general		0..1	boolean	Element id nfdi4health-lm-mds-design.Design.interventional.masking.general Short description Masking implemented? Definition Indication whether a masking (or blinding) of intervention(s) assignment is implemented (i.e., whether someone is prevented from having knowledge of the interventions assigned to individual participants). Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
roles		0..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.interventional.masking.roles Short description Who is masked? Definition If masking is implemented, the party(ies) who are masked. Comments Cardinality: 0.., if Design.interventional.masking.general == true 0..0, if Design.interventional.masking.general == false Data type* CodeableConcept Binding NFDI4Health_VS_MDS_Study_Masking_Roles_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
description		0..1	string	Element id nfdi4health-lm-mds-design.Design.interventional.masking.description Short description Additional information about masking Definition If needed, additional descriptive information about masking (e.g. information about other parties who may be masked). Comments Cardinality: 0..1, if Design.interventional.masking.general == true 0..0, if Design.interventional.masking.general == false Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
allocation		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.interventional.allocation Short description Type of allocation of participants to an arm Definition Type of allocation/assignment of individual participants of the [RESOURCE] to an arm. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Study_Allocation_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
offLabelUse		0..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-design.Design.interventional.offLabelUse Short description Off-label use of a drug product Definition Unapproved (off-label) use of a drug product. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD

Specific MDS modules

Nutritional Epidemiology

Module_Nutritional_Epidemiology (nfdi4health-lm-mds-ne)			Element	Element id nfdi4health-lm-mds-ne Short description NFDI4Health Module Nutritional Epidemiology Definition NFDI4Health Logical Module of Module Nutritional Epidemiology V3.3.1 Data type Element Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-ne.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-ne.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
DietAssessment		0..*	BackboneElement	Element id nfdi4health-lm-mds-ne.DietAssessment Short description Diet assessment information collected in the [RESOURCE] Definition Group of items providing information on diet assessment. Comments Cardinality: 1.., if Resource.nutritionalData == "Yes" 0..0, if Resource.nutritionalData == "No" Data type* BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-ne.DietAssessment.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-ne.DietAssessment.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-ne.DietAssessment.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
instrument		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-ne.DietAssessment.instrument Short description Dietary assessment instrument used Definition Specification of the dietary assessment instrument like food record or diet history. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_NE_Instrument_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
ffqItemsNumber	C	0..1	Quantity	Element id nfdi4health-lm-mds-ne.DietAssessment.ffqItemsNumber Short description Number of items in the food frequency questionnaire (FFQ) Definition The number of items inquired by the food frequency questionnaire (FFQ). A food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. Comments Cardinality: 1..1, if DietAssessment.instrument == "Food frequency questionnaire (FFQ)" 0..0, if DietAssessment.instrument != "Food frequency questionnaire (FFQ)" Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
mode		1..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-ne.DietAssessment.mode Short description Modes used to apply the dietary assessment instrument Definition How the dietary assessment instrument was applied. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_NE_Mode_NCI_MSH_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
device		1..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-ne.DietAssessment.device Short description Devices used to apply the dietary assessment instrument Definition Specification of device(s) used to apply the dietary assessment instrument to participants. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_NE_Device_NCI_SNOMEDCT_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
portionSizeEstimation		1..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-ne.DietAssessment.portionSizeEstimation Short description How was the portion size estimated? Definition Specification of how the portion size was inquired in the dietary assessment instrument. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_NE_Portion_Size_SNOMEDCT_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
referencePeriodUnit		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-ne.DietAssessment.referencePeriodUnit Short description Reference period unit Definition Indication of the reference period the dietary assessment instrument refers to (e.g. 24-h recall refers to the previous day) Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_NE_Reference_Period_Unit_SNOMEDCT (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
referencePeriodNumber	C	1..1	Quantity	Element id nfdi4health-lm-mds-ne.DietAssessment.referencePeriodNumber Short description Number of reference period units Definition Numerical value of reference period units. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
repeat		1..1	boolean	Element id nfdi4health-lm-mds-ne.DietAssessment.repeat Short description Instrument applied repeatedly? Definition Indication whether the same instrument was applied repeatedly. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
repeatFrequency	C	0..1	Quantity	Element id nfdi4health-lm-mds-ne.DietAssessment.repeatFrequency Short description Frequency of instrument application Definition Indication of how often the dietary assessment instrument was repeatedly applied. Comments Cardinality: 1..1, if DietAssessment.repeat == "Yes" 0..0, if DietAssessment.repeat == "No" Data type Quantity Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
validity		1..1	boolean	Element id nfdi4health-lm-mds-ne.DietAssessment.validity Short description Instrument validated? Definition Indication whether the dietary assessment instrument was validated. Validity refers to whether an instrument accurately measures what it is intended to measure. This is typically assessed by comparison to a gold standard using methods like correlations or Bland-Altman plots. It indicates how suitable the instrument is for its purpose and whether it can be applied to other populations beyond the original study. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
validityReference		0..1	string	Element id nfdi4health-lm-mds-ne.DietAssessment.validityReference Short description validityReference Definition Reference describing the validation Requirements Indication of the reference describing the validation. Publications that describe the validation of an instrument. Ideally, this should include studies that have undergone a peer-review process. Code or documentation that has not been peer-reviewed would not be considered sufficient in this context. Comments Cardinality: 1..1, if DietAssessment.validity == "Yes" 0..0, if DietAssessment.validity == "No" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
reliability		1..1	boolean	Element id nfdi4health-lm-mds-ne.DietAssessment.reliability Short description Instrument described according to reliability? Definition Indication whether the dietary assessment instrument was described according to its reliability. Reliability reflects how consistently an instrument produces the same results across repeated uses. This is critical for longitudinal studies using the same tools over time. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
reliabilityReference		0..1	string	Element id nfdi4health-lm-mds-ne.DietAssessment.reliabilityReference Short description Reference describing reliability measures Definition Indication of the reference describing the reliability measures. Comments Cardinality: 1..1, if DietAssessment.reliability == "Yes" 0..0, if DietAssessment.reliability == "No" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
dietarySupplements		1..1	boolean	Element id nfdi4health-lm-mds-ne.DietAssessment.dietarySupplements Short description Dietary supplements inquired? Definition Indication whether the dietary assessment instrument inquires information about dietary supplements. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`

Epidemiology of Chronic Diseases

NFDI4Health_LM_MDS_EOCD (nfdi4health-lm-mds-eocd)			Element	Element id nfdi4health-lm-mds-eocd Short description NFDI4Health Module Epidemiology of Chronic Diseases Definition NFDI4Health Logical Model of Module Epidemiology of Chronic Diseases V3.3.1 Data type Element Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-eocd.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-eocd.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
ChronicDiseasesEpidemiology		0..*	BackboneElement	Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology Short description Chronic disease data collected in the [RESOURCE] Definition Group of items providing information on chronic disease data collection. Comments 1.., if Resource.chronicDiseases == "Yes" AND Resource.classification.type == ("Study protocol" OR "Informed consent form" OR "Patient information sheet" OR "Manual of operations (SOPs)" OR "Statistical analysis plan" OR "Data management plan" OR "Case report form" OR "Interview scheme and themes" OR "Observation guide" OR "Discussion guide" OR "Participant tasks" OR "Other study document" OR "Other") 0..0, if Resource.chronicDiseases != "Yes" OR Resource.classification.type != ("Study protocol" OR "Informed consent form" OR "Patient information sheet" OR "Manual of operations (SOPs)" OR "Statistical analysis plan" OR "Data management plan" OR "Case report form" OR "Interview scheme and themes" OR "Observation guide" OR "Discussion guide" OR "Participant tasks" OR "Other study document" OR "Other") Data type* BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
commonChronicDiseaseName		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.commonChronicDiseaseName Short description Common chronic diseases on which data were collected Definition Specification of the common chronic diseases on which data were collected in the Group of items providing information on chronic disease data collection. Comments Additional information: The values originate from the following sources: 1) 10 types of cancer with the highest incidence in Germany, by gender, based on 2017/2018 German cancer registry data (RKI, Zentrum für Krebsregisterdaten, https://www.krebsdaten.de/); 2) 10 cardiovascular diseases with highest mortality in Germany in 2020 (www.destatis.de). <br/>All values follow the classifiction system ICD-10 (WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10), https://icd.who.int/en). Data type CodeableConcept Binding NFDI4Health_VS_MDS_CD_CommonChronicDiseaseName_SCT_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
dataCollected		1..1	CodeableConceptBinding	Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.dataCollected Short description Type of data collected Definition Specification of the type of data collected. Comments 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. Data type CodeableConcept Binding NFDI4Health_VS_MDS_CD_DataCollected_NCI (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
informationSources		1..*	CodeableConceptBinding	Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.informationSources Short description From which sources were data generated/extracted? Definition Specification of the source(s) from which information was generated/extracted. Comments Additional information: Treat prevalent and incident diseases separately (selected values should be specific for prevalent diseases and then separately incident diseases). Data type CodeableConcept Binding NFDI4Health_VS_MDS_CD_Information_Sources_NCI_Local (required) Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
outcomesVerificationMethods		0..*	string	Element id nfdi4health-lm-mds-eocd.ChronicDiseasesEpidemiology.outcomesVerificationMethods Short description How were outcomes generally verified? Definition Methods of verification differ by study. All the details per outcome are not needed here but rather an explanation of how outcomes were verified in general. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`

Record Linkage

NFDI4Health_LM_Metadataschema_RecordLinkage (nfdi4health-lm-mds-rl)			Element	Element id nfdi4health-lm-mds-rl Short description NFDI4Health Module Record Linkage Definition NFDI4Health Logical Module of Module Record Linkage V3.3.1 Data type Element Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-rl.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-rl.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
RecordLinkage		0..1	BackboneElement	Element id nfdi4health-lm-mds-rl.RecordLinkage Short description Information about record linkage for the [RESOURCE] Definition Group of items providing information on record linkage. Comments Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == "Yes" 0..0, if Design.dataSharingPlan.recordLinkage == "No" Data type BackboneElement Conditions The cardinality or value of this element may be affected by these constraints: ele-1 Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id nfdi4health-lm-mds-rl.RecordLinkage.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-rl.RecordLinkage.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Slicing Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! C	0..*	Extension	There are no (further) constraints on this element Element id nfdi4health-lm-mds-rl.RecordLinkage.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
legalBasis		0..1	boolean	Element id nfdi4health-lm-mds-rl.RecordLinkage.legalBasis Short description Legal regulation/permission for record linkage Definition Indication whether there are specific regulations/permissions for record linkage. Comments Additional information: Whether any specific legal regulations/permissions exist (e.g. for social data, for cancer registry data, hospital data, etc.). Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
legalBasisDetails		0..1	string	Element id nfdi4health-lm-mds-rl.RecordLinkage.legalBasisDetails Short description Specific legal basis allowing record linkage Definition Information specifying which specific legal basis allows for record linkage. Comments Additional information: If existing, any specific legal regulations/permissions (e.g. for social data, for cancer registry data, hospital data, etc.). Cardinality: 1..1, if RecordLinkage.legalBasis == "Yes" 0..0, if RecordLinkage.legalBasis == "No" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
informedConsent		0..1	boolean	Element id nfdi4health-lm-mds-rl.RecordLinkage.informedConsent Short description Informed consent for record linkage obtained? Definition Indication whether an informed consent that allows record linkage has been obtained. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
responsibleInstitutions		0..*	string	Element id nfdi4health-lm-mds-rl.RecordLinkage.responsibleInstitutions Short description Responsible authorities Definition Institutions and authorities that must agree to the record linkage. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
additionalCosts		0..1	boolean	Element id nfdi4health-lm-mds-rl.RecordLinkage.additionalCosts Short description Additional costs for record linkage Definition Indication whether there are additional costs for record linkage. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
identifiers		0..*	string	Element id nfdi4health-lm-mds-rl.RecordLinkage.identifiers Short description Identifiers for record linkage Definition Identifiers that can be used for record linkage (e.g. names, date of birth, zip code, insurance number or control number as in cancer registries). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
furtherDetails		0..1	string	Element id nfdi4health-lm-mds-rl.RecordLinkage.furtherDetails Short description Further details important for conducting record linkage Definition Additional important details for conducting record linkage. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
exampleResources		0..*	string	Element id nfdi4health-lm-mds-rl.RecordLinkage.exampleResources Short description Record linkage example resources Definition DOIs of additional related resources specific to record linkage (e.g., publications). Comments Please do not repeat those already entered in the section 'Related resources' Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`