Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
Page standards status: Draft | Maturity Level: 1 |
Definitions for the study-design resource profile.
Guidance on how to interpret the contents of this table can be foundhere
0. ResearchStudy | |
Definition | A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future. |
Short | Investigation to increase healthcare-related patient-independent knowledge |
Comments | The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people. |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | Study |
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
2. ResearchStudy.implicitRules | |
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Short | A set of rules under which this content was created |
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. ResearchStudy.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
6. ResearchStudy.extension | |
Definition | An Extension May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | ExtensionAdditional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on ResearchStudy.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
8. ResearchStudy.extension:author | |
Slice Name | author |
Definition | An individual or organization primarily involved in the creation and maintenance of the artifact. |
Short | Who authored the artifact |
Control | 0..* |
Type | Extension(Artifact Author) (Extension Type: ContactDetail) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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() ) |
10. ResearchStudy.extension:RelatesToWithQuotation | |
Slice Name | RelatesToWithQuotation |
Definition | Resource (FHIR or non-FHIR) associated with the Resource, plus specification of a portion quoted from the Resource. |
Short | Related artifact with quoted portion |
Control | 0..* |
Type | Extension(RelatesToWithQuotation) (Complex Extension) |
Is Modifier | false |
Must Support | false |
Invariants | 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() ) |
12. ResearchStudy.extension:confidentialityStatement | |
Slice Name | confidentialityStatement |
Definition | Sponsor Confidentiality Statement, if applicable. |
Short | Sponsor Confidentiality Statement, if applicable. |
Control | 0..1 |
Type | Extension(ResearchStudySponsorConfidentialityStatement) (Extension Type: string) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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() ) |
14. ResearchStudy.extension:saeReportingMethod | |
Slice Name | saeReportingMethod |
Definition | Method for reporting Serious Adverse Events. |
Short | Method for reporting Serious Adverse Events. |
Comments | Report Serious Adverse Events to the sponsor. Enter SAE reporting method(s). Refer to Section 9.4 for detailed reporting instructions. |
Control | 0..1 |
Type | Extension(ResearchStudySaeReportingMethod) (Extension Type: string) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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() ) |
16. ResearchStudy.extension:studyAmendment | |
Slice Name | studyAmendment |
Definition | An amendment to a study protocol. |
Short | An amendment to a study protocol |
Control | 0..1 |
Type | Extension(ResearchStudyStudyAmendment) (Complex Extension) |
Is Modifier | false |
Must Support | false |
Invariants | 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() ) |
18. ResearchStudy.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
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. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. ResearchStudy.title | |
Definition | The human readable name of the research study. |
Short | Human readable name of the study |
Comments | The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. ResearchStudy.status | |
Definition | The publication state of the resource (not of the study). |
Short | draft | active | retired | unknown |
Control | 1..1 |
Binding | The codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 (required to http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 )Codes that convey the current publication status of the research study resource. |
Type | code |
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be foundhere
0. ResearchStudy | |
2. ResearchStudy.extension | |
Slicing | This element introduces a set of slices on ResearchStudy.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
4. ResearchStudy.extension:author | |
Slice Name | author |
Control | 0..* |
Type | Extension(Artifact Author) (Extension Type: ContactDetail) |
6. ResearchStudy.extension:RelatesToWithQuotation | |
Slice Name | RelatesToWithQuotation |
Control | 0..* |
Type | Extension(RelatesToWithQuotation) (Complex Extension) |
8. ResearchStudy.extension:confidentialityStatement | |
Slice Name | confidentialityStatement |
Control | 0..1 |
Type | Extension(ResearchStudySponsorConfidentialityStatement) (Extension Type: string) |
10. ResearchStudy.extension:saeReportingMethod | |
Slice Name | saeReportingMethod |
Control | 0..1 |
Type | Extension(ResearchStudySaeReportingMethod) (Extension Type: string) |
12. ResearchStudy.extension:studyAmendment | |
Slice Name | studyAmendment |
Control | 0..1 |
Type | Extension(ResearchStudyStudyAmendment) (Complex Extension) |
14. ResearchStudy.title | |
Comments | The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches. |
Guidance on how to interpret the contents of this table can be foundhere
0. ResearchStudy | |
Definition | A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future. |
Short | Investigation to increase healthcare-related patient-independent knowledge |
Comments | The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people. |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | Study |
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty() )dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource ( contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty() )dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() )dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty() )dom-6: A resource should have narrative for robust management ( text.`div`.exists() ) |
2. ResearchStudy.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Short | Logical id of this artifact |
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
Control | 0..1 |
Type | id |
Is Modifier | false |
Must Support | false |
Summary | true |
4. ResearchStudy.meta | |
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. |
Short | Metadata about the resource |
Control | 0..1 |
Type | Meta |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
6. ResearchStudy.implicitRules | |
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Short | A set of rules under which this content was created |
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
8. ResearchStudy.language | |
Definition | The base language in which the resource is written. |
Short | Language of the resource content |
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3 )IETF language tag for a human language |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
10. ResearchStudy.text | |
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. |
Short | Text summary of the resource, for human interpretation |
Comments | Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
12. ResearchStudy.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
14. ResearchStudy.extension | |
Definition | An Extension |
Short | Extension |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
Slicing | This element introduces a set of slices on ResearchStudy.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
16. ResearchStudy.extension:author | |
Slice Name | author |
Definition | An individual or organization primarily involved in the creation and maintenance of the artifact. |
Short | Who authored the artifact |
Control | 0..* |
Type | Extension(Artifact Author) (Extension Type: ContactDetail) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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() ) |
18. ResearchStudy.extension:RelatesToWithQuotation | |
Slice Name | RelatesToWithQuotation |
Definition | Resource (FHIR or non-FHIR) associated with the Resource, plus specification of a portion quoted from the Resource. |
Short | Related artifact with quoted portion |
Control | 0..* |
Type | Extension(RelatesToWithQuotation) (Complex Extension) |
Is Modifier | false |
Must Support | false |
Invariants | 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() ) |
20. ResearchStudy.extension:confidentialityStatement | |
Slice Name | confidentialityStatement |
Definition | Sponsor Confidentiality Statement, if applicable. |
Short | Sponsor Confidentiality Statement, if applicable. |
Control | 0..1 |
Type | Extension(ResearchStudySponsorConfidentialityStatement) (Extension Type: string) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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() ) |
22. ResearchStudy.extension:saeReportingMethod | |
Slice Name | saeReportingMethod |
Definition | Method for reporting Serious Adverse Events. |
Short | Method for reporting Serious Adverse Events. |
Comments | Report Serious Adverse Events to the sponsor. Enter SAE reporting method(s). Refer to Section 9.4 for detailed reporting instructions. |
Control | 0..1 |
Type | Extension(ResearchStudySaeReportingMethod) (Extension Type: string) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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() ) |
24. ResearchStudy.extension:studyAmendment | |
Slice Name | studyAmendment |
Definition | An amendment to a study protocol. |
Short | An amendment to a study protocol |
Control | 0..1 |
Type | Extension(ResearchStudyStudyAmendment) (Complex Extension) |
Is Modifier | false |
Must Support | false |
Invariants | 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() ) |
26. ResearchStudy.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
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. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
28. ResearchStudy.url | |
Definition | Canonical identifier for this study resource, represented as a globally unique URI. |
Short | Canonical identifier for this study resource |
Control | 0..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
30. ResearchStudy.identifier | |
Definition | Identifiers assigned to this research study by the sponsor or other systems. |
Short | Business Identifier for study |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Requirements | Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. ResearchStudy.version | |
Definition | The business version for the study record. |
Short | The business version for the study record |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
34. ResearchStudy.name | |
Definition | Name for this study (computer friendly). |
Short | Name for this study (computer friendly) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
36. ResearchStudy.title | |
Definition | The human readable name of the research study. |
Short | Human readable name of the study |
Comments | The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
38. ResearchStudy.label | |
Definition | Additional names for the study. |
Short | Additional names for the study |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
40. ResearchStudy.label.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
42. ResearchStudy.label.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. ResearchStudy.label.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
46. ResearchStudy.label.type | |
Definition | Kind of name. |
Short | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid |
Control | 0..1 |
Binding | Unless not suitable, these codes SHALL be taken from TitleType (extensible to http://hl7.org/fhir/ValueSet/title-type )desc. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
48. ResearchStudy.label.value | |
Definition | The name. |
Short | The name |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
50. ResearchStudy.protocol | |
Definition | The set of steps expected to be performed as part of the execution of the study. |
Short | Steps followed in executing study |
Control | 0..* |
Type | Reference(PlanDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
52. ResearchStudy.partOf | |
Definition | A larger research study of which this particular study is a component or step. |
Short | Part of larger study |
Control | 0..* |
Type | Reference(ResearchStudy) |
Is Modifier | false |
Must Support | false |
Summary | true |
Requirements | Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. |
Alternate Names | container |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
54. ResearchStudy.citeAs | |
Definition | Display of the bibliographic citation of this ResearchStudy. |
Short | How to cite this ResearchStudy |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. ResearchStudy.relatesTo | |
Definition | Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist. |
Short | Relationships to other Resources |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
58. ResearchStudy.relatesTo.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
60. ResearchStudy.relatesTo.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
62. ResearchStudy.relatesTo.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
64. ResearchStudy.relatesTo.type | |
Definition | The type of relationship to the related artifact. |
Short | documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes |
Control | 1..1 |
Binding | The codes SHALL be taken from ArtifactRelationshipType (required to http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3 )The type of relationship to the related artifact. |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. ResearchStudy.relatesTo.target[x] | |
Definition | The artifact that is related to this ResearchStudy Resource. |
Short | The artifact that is related to this ResearchStudy |
Control | 1..1 |
Type | Choice of: uri, Attachment, canonical(Resource), Reference(Resource), markdown |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
68. ResearchStudy.date | |
Definition | The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes. |
Short | Date the resource last changed |
Control | 0..1 |
Type | dateTime |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
70. ResearchStudy.status | |
Definition | The publication state of the resource (not of the study). |
Short | draft | active | retired | unknown |
Control | 1..1 |
Binding | The codes SHALL be taken from PublicationStatus (required to http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 )Codes that convey the current publication status of the research study resource. |
Type | code |
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
72. ResearchStudy.primaryPurposeType | |
Definition | The type of study based upon the intent of the study activities. A classification of the intent of the study. |
Short | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility |
Control | 0..1 |
Binding | The codes SHOULD be taken from ResearchStudyPrimaryPurposeType (preferred to http://hl7.org/fhir/ValueSet/research-study-prim-purp-type )Codes for the main intent of the study. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
74. ResearchStudy.phase | |
Definition | The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. |
Short | Classifier used for clinical trials |
Control | 0..1 |
Binding | The codes SHOULD be taken from ResearchStudyTrialPhase (preferred to http://hl7.org/fhir/ValueSet/research-study-trial-phase )Classifiers of clinical trial progression for human use. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
76. ResearchStudy.studyDesign | |
Definition | Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. |
Short | Classifications of the study design characteristics |
Control | 0..* |
Binding | The codes SHOULD be taken from StudyDesign (preferred to http://hl7.org/fhir/ValueSet/study-design )This is a set of terms for study design characteristics. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
78. ResearchStudy.focus | |
Definition | The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. |
Short | Drugs, devices, etc. under study |
Control | 0..* |
Binding | For example codes, see ResearchStudyFocusType (example to http://hl7.org/fhir/ValueSet/research-study-focus-type )Some example codes of research study focus |
Type | CodeableReference(Medication, MedicinalProductDefinition, SubstanceDefinition, DeviceDefinition, PlanDefinition) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
80. ResearchStudy.condition | |
Definition | The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code. |
Short | Condition being studied |
Control | 0..* |
Binding | For example codes, see ConditionProblemDiagnosisCodes (example to http://hl7.org/fhir/ValueSet/condition-code )Identification of the condition or diagnosis. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. ResearchStudy.keyword | |
Definition | Key terms to aid in searching for or filtering the study. |
Short | Used to search for the study |
Control | 0..* |
Binding | For example codes, see ResearchStudyFocusType (example to http://hl7.org/fhir/ValueSet/research-study-focus-type )Some example codes. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
84. ResearchStudy.region | |
Definition | A country, state or other area where the study is taking place rather than its precise geographic location or address. |
Short | Geographic area for the study |
Control | 0..* |
Binding | Unless not suitable, these codes SHALL be taken from JurisdictionValueSet (extensible to http://hl7.org/fhir/ValueSet/jurisdiction )Countries and regions within which this artifact is targeted for use. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
86. ResearchStudy.descriptionSummary | |
Definition | A brief text for explaining the study. |
Short | Brief text explaining the study |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
88. ResearchStudy.description | |
Definition | A detailed and human-readable narrative of the study. E.g., study abstract. |
Short | Detailed narrative of the study |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
90. ResearchStudy.period | |
Definition | Identifies the start date and the expected (or actual, depending on status) end date for the study. |
Short | When the study began and ended |
Control | 0..1 |
Type | Period |
Is Modifier | false |
Must Support | false |
Summary | true |
Alternate Names | timing |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
92. ResearchStudy.site | |
Definition | A facility in which study activities are conducted. |
Short | Facility where study activities are conducted |
Control | 0..* |
Type | Reference(Location, ResearchStudy, Organization) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
94. ResearchStudy.note | |
Definition | Comments made about the study by the performer, subject or other participants. |
Short | Comments made about the study |
Control | 0..* |
Type | Annotation |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
96. ResearchStudy.classifier | |
Definition | Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource. |
Short | Classification for the study |
Control | 0..* |
Binding | For example codes, see ResearchStudyClassifiers (example to http://hl7.org/fhir/ValueSet/research-study-classifiers )desc. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
98. ResearchStudy.associatedParty | |
Definition | Sponsors, collaborators, and other parties. |
Short | Sponsors, collaborators, and other parties |
Comments | For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided. |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Requirements | While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles. |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
100. ResearchStudy.associatedParty.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
102. ResearchStudy.associatedParty.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
104. ResearchStudy.associatedParty.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
106. ResearchStudy.associatedParty.name | |
Definition | Name of associated party. |
Short | Name of associated party |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
108. ResearchStudy.associatedParty.role | |
Definition | Type of association. |
Short | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb |
Control | 1..1 |
Binding | Unless not suitable, these codes SHALL be taken from ResearchStudyPartyRole (extensible to http://hl7.org/fhir/ValueSet/research-study-party-role )desc. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
110. ResearchStudy.associatedParty.period | |
Definition | Identifies the start date and the end date of the associated party in the role. |
Short | When active in the role |
Comments | The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods. |
Control | 0..* |
Type | Period |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
112. ResearchStudy.associatedParty.classifier | |
Definition | A categorization other than role for the associated party. |
Short | nih | fda | government | nonprofit | academic | industry |
Control | 0..* |
Binding | For example codes, see ResearchStudyPartyOrgType (example to http://hl7.org/fhir/ValueSet/research-study-party-organization-type )A characterization or type of the entity. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
114. ResearchStudy.associatedParty.party | |
Definition | Individual or organization associated with study (use practitionerRole to specify their organisation). |
Short | Individual or organization associated with study (use practitionerRole to specify their organisation) |
Comments | Suggestions of a better attribute name are appreciated |
Control | 0..1 |
Type | Reference(Practitioner, PractitionerRole, Organization) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
116. ResearchStudy.progressStatus | |
Definition | Status of study with time for that status. |
Short | Status of study with time for that status |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
118. ResearchStudy.progressStatus.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
120. ResearchStudy.progressStatus.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
122. ResearchStudy.progressStatus.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
124. ResearchStudy.progressStatus.state | |
Definition | Label for status or state (e.g. recruitment status). |
Short | Label for status or state (e.g. recruitment status) |
Control | 1..1 |
Binding | Unless not suitable, these codes SHALL be taken from ResearchStudyStatus (extensible to http://hl7.org/fhir/ValueSet/research-study-status )defn. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
126. ResearchStudy.progressStatus.actual | |
Definition | An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date. |
Short | Actual if true else anticipated |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. ResearchStudy.progressStatus.period | |
Definition | Date range. |
Short | Date range |
Control | 0..1 |
Type | Period |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
130. ResearchStudy.whyStopped | |
Definition | A description and/or code explaining the premature termination of the study. |
Short | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design |
Control | 0..1 |
Binding | For example codes, see ResearchStudyReasonStopped (example to http://hl7.org/fhir/ValueSet/research-study-reason-stopped )Codes for why the study ended prematurely. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
132. ResearchStudy.recruitment | |
Definition | Target or actual group of participants enrolled in study. |
Short | Target or actual group of participants enrolled in study |
Control | 0..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
134. ResearchStudy.recruitment.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
136. ResearchStudy.recruitment.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
138. ResearchStudy.recruitment.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
140. ResearchStudy.recruitment.targetNumber | |
Definition | Estimated total number of participants to be enrolled. |
Short | Estimated total number of participants to be enrolled |
Control | 0..1 |
Type | unsignedInt |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
142. ResearchStudy.recruitment.actualNumber | |
Definition | Actual total number of participants enrolled in study. |
Short | Actual total number of participants enrolled in study |
Control | 0..1 |
Type | unsignedInt |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
144. ResearchStudy.recruitment.eligibility | |
Definition | Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'. |
Short | Inclusion and exclusion criteria |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
146. ResearchStudy.recruitment.actualGroup | |
Definition | Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'. |
Short | Group of participants who were enrolled in study |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
148. ResearchStudy.comparisonGroup | |
Definition | Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}. |
Short | Defined path through the study for a subject |
Comments | In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups. |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | arm |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
150. ResearchStudy.comparisonGroup.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
152. ResearchStudy.comparisonGroup.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
154. ResearchStudy.comparisonGroup.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
156. ResearchStudy.comparisonGroup.targetNumber | |
Definition | Estimated total number of participants to be enrolled in the comparison group. |
Short | Estimated total number of participants to be enrolled in the comparison group |
Control | 0..1 |
Type | unsignedInt |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
158. ResearchStudy.comparisonGroup.actualNumber | |
Definition | Actual total number of participants enrolled in the comparison group. |
Short | Actual total number of participants enrolled in the comparison group |
Control | 0..1 |
Type | unsignedInt |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
160. ResearchStudy.comparisonGroup.eligibility | |
Definition | Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'. |
Short | Inclusion and exclusion criteria for the comparison group |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
162. ResearchStudy.comparisonGroup.observedGroup | |
Definition | Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'. |
Short | Group of participants who were enrolled in the comparison group |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
164. ResearchStudy.objective | |
Definition | A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. |
Short | A goal for the study |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
166. ResearchStudy.objective.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
168. ResearchStudy.objective.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
170. ResearchStudy.objective.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
172. ResearchStudy.objective.name | |
Definition | Unique, human-readable label for this objective of the study. |
Short | Label for the objective |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
174. ResearchStudy.objective.type | |
Definition | The kind of study objective. |
Short | primary | secondary | exploratory |
Control | 0..1 |
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to http://hl7.org/fhir/ValueSet/research-study-objective-type )Codes for the kind of study objective. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
176. ResearchStudy.objective.description | |
Definition | Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description). |
Short | Description of the objective |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
178. ResearchStudy.objective.outcomeMeasure | |
Definition | An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. |
Short | A variable measured during the study |
Comments | A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
180. ResearchStudy.objective.outcomeMeasure.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
182. ResearchStudy.objective.outcomeMeasure.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
184. ResearchStudy.objective.outcomeMeasure.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
186. ResearchStudy.objective.outcomeMeasure.name | |
Definition | Label for the outcome measure. |
Short | Label for the outcome measure |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
188. ResearchStudy.objective.outcomeMeasure.type | |
Definition | The kind of outcome measure. |
Short | primary | secondary | exploratory |
Control | 0..1 |
Binding | The codes SHOULD be taken from ResearchStudyObjectiveType (preferred to http://hl7.org/fhir/ValueSet/research-study-objective-type )defn. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
190. ResearchStudy.objective.outcomeMeasure.description | |
Definition | Description of the outcome measure. |
Short | Description of the outcome measure |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
192. ResearchStudy.objective.outcomeMeasure.endpoint | |
Definition | Definition of the outcome measure. |
Short | Definition of the outcome measure |
Control | 1..1 |
Type | Reference(EvidenceVariable) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
194. ResearchStudy.objective.outcomeMeasure.population | |
Definition | Population for this estimand. |
Short | Population for this estimand |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
196. ResearchStudy.objective.outcomeMeasure.intervention | |
Definition | Comparison group of interest. |
Short | Comparison group of interest |
Comments | To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
198. ResearchStudy.objective.outcomeMeasure.comparator | |
Definition | Comparison group for comparison. |
Short | Comparison group for comparison |
Comments | To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id |
Control | 0..1 |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
200. ResearchStudy.objective.outcomeMeasure.summaryMeasure | |
Definition | Statistical measure for treatment effect estimate. |
Short | Statistical measure for treatment effect estimate |
Control | 0..1 |
Binding | For example codes, see StatisticType (example to http://hl7.org/fhir/ValueSet/statistic-type )The type of a statistic, e.g. relative risk or mean. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
202. ResearchStudy.objective.outcomeMeasure.eventHandling | |
Definition | Handling of intercurrent event. |
Short | Handling of intercurrent event |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()) ) |
204. ResearchStudy.objective.outcomeMeasure.eventHandling.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
206. ResearchStudy.objective.outcomeMeasure.eventHandling.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
208. ResearchStudy.objective.outcomeMeasure.eventHandling.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
210. ResearchStudy.objective.outcomeMeasure.eventHandling.event | |
Definition | The event. |
Short | The event |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
212. ResearchStudy.objective.outcomeMeasure.eventHandling.group | |
Definition | The group that is affected by this event handling. |
Short | The group that is affected by this event handling |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
214. ResearchStudy.objective.outcomeMeasure.eventHandling.handling | |
Definition | How the data is handled. |
Short | How the data is handled |
Control | 0..1 |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
216. ResearchStudy.objective.outcomeMeasure.eventHandling.description | |
Definition | Text summary of event handling. |
Short | Text summary of event handling |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
218. ResearchStudy.result | |
Definition | Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov. |
Short | Link to results generated during the study |
Control | 0..* |
Type | Reference(Citation, Composition, DiagnosticReport, Evidence) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |