Extensions for Using Data Elements from FHIR R5 in FHIR R4
0.1.0 - STU
Extensions for Using Data Elements from FHIR R5 in FHIR R4
0.1.0 - STU
Extensions for Using Data Elements from FHIR R5 in FHIR R4 - Downloaded Version null See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 0 |
Definitions for the ext-R5-ResearchSubject.progress extension.
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | R5: Optional Extension Element - found in all resources. |
| Short | R5: Subject status (new)Optional Extensions Element |
| Comments | Element It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording. |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Is Modifier | 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())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()) |
| 2. Extension.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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 |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists())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()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 4. Extension.extension:type | |
| Slice Name | type |
| Definition | R5: |
| Short | R5: state | milestone (new)Additional content defined by implementations |
| Comments | Element |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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())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()) |
| 6. Extension.extension:type.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | type |
| 8. Extension.extension:type.value[x] | |
| Definition | Identifies the aspect of the subject's journey that the state refers to. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | state | milestoneValue of extension |
| Control | 0..1 |
| Binding | For example codes, see For codes, see R5ResearchSubjectStateTypeForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-state-type-for-R4|0.1.0)Identifies the kind of state being refered to. |
| Type | CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. Extension.extension:subjectState | |
| Slice Name | subjectState |
| Definition | R5: |
| Short | R5: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn (new)Additional content defined by implementations |
| Comments | Element |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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())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. Extension.extension:subjectState.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | subjectState |
| 14. Extension.extension:subjectState.value[x] | |
| Definition | The current state of the subject. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawnValue of extension |
| Control | 0..1 |
| Binding | The codes SHALL be taken from For codes, see R5ResearchSubjectStateForR4 (0.1.0) (required to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-state-for-R4|0.1.0)Indicates the progression of a study subject through a study. |
| Type | CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. Extension.extension:milestone | |
| Slice Name | milestone |
| Definition | R5: |
| Short | R5: SignedUp | Screened | Randomized (new)Additional content defined by implementations |
| Comments | Element |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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())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. Extension.extension:milestone.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | milestone |
| 20. Extension.extension:milestone.value[x] | |
| Definition | The milestones the subject has passed through. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | SignedUp | Screened | RandomizedValue of extension |
| Comments | There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken. |
| Control | 0..1 |
| Binding | For example codes, see For codes, see R5ResearchSubjectMilestoneForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-milestone-for-R4|0.1.0)Indicates the progression of a study subject through the study milestones. |
| Type | CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. Extension.extension:reason | |
| Slice Name | reason |
| Definition | R5: |
| Short | R5: State change reason (new)Additional content defined by implementations |
| Comments | Element |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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())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. Extension.extension:reason.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | reason |
| 26. Extension.extension:reason.value[x] | |
| Definition | The reason for the state change. If coded it should follow the formal subject state model. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | State change reasonValue of extension |
| Control | 0..1 |
| Binding | For example codes, see For codes, see R5StateChangeReasonForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-state-change-reason-for-R4|0.1.0)Indicates why the state of the subject changed. |
| Type | CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 28. Extension.extension:startDate | |
| Slice Name | startDate |
| Definition | R5: |
| Short | R5: State change date (new)Additional content defined by implementations |
| Comments | Element |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | This was originally defined as the date when the change in status occurred. This assumed all states were recorded which is not true. Hence the need to track the end of the state. Element |
| 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())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()) |
| 30. Extension.extension:startDate.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | startDate |
| 32. Extension.extension:startDate.value[x] | |
| Definition | The date when the new status started. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | State change dateValue of extension |
| Comments | This is NOT the date the change in state was recorded. |
| Control | 0..1 |
| Type | dateTime, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [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 |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 34. Extension.extension:endDate | |
| Slice Name | endDate |
| Definition | R5: |
| Short | R5: State change date (new)Additional content defined by implementations |
| Comments | Element |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | See the requirement on the start date. Element |
| 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())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()) |
| 36. Extension.extension:endDate.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | endDate |
| 38. Extension.extension:endDate.value[x] | |
| Definition | The date when the state ended. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | State change dateValue of extension |
| Control | 0..1 |
| Type | dateTime, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [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 |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 40. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchSubject.progress |
| 42. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..01 |
| Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))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. Extension | |
| Definition | R5: |
| Short | R5: Subject status (new) |
| Comments | Element It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording. |
| Control | 0..* |
| Is Modifier | false |
| 2. Extension.extension | |
| Control | 0..* |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 4. Extension.extension:type | |
| Slice Name | type |
| Definition | R5: |
| Short | R5: state | milestone (new) |
| Comments | Element |
| Control | 0..1 |
| Requirements | Element |
| 6. Extension.extension:type.url | |
| Control | 1..1 |
| Fixed Value | type |
| 8. Extension.extension:type.value[x] | |
| Definition | Identifies the aspect of the subject's journey that the state refers to. |
| Short | state | milestone |
| Control | 0..1 |
| Binding | For example codes, see R5ResearchSubjectStateTypeForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-state-type-for-R4|0.1.0)Identifies the kind of state being refered to. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 10. Extension.extension:subjectState | |
| Slice Name | subjectState |
| Definition | R5: |
| Short | R5: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn (new) |
| Comments | Element |
| Control | 0..1 |
| Requirements | Element |
| 12. Extension.extension:subjectState.url | |
| Control | 1..1 |
| Fixed Value | subjectState |
| 14. Extension.extension:subjectState.value[x] | |
| Definition | The current state of the subject. |
| Short | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn |
| Control | 0..1 |
| Binding | The codes SHALL be taken from R5ResearchSubjectStateForR4 (0.1.0) (required to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-state-for-R4|0.1.0)Indicates the progression of a study subject through a study. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 16. Extension.extension:milestone | |
| Slice Name | milestone |
| Definition | R5: |
| Short | R5: SignedUp | Screened | Randomized (new) |
| Comments | Element |
| Control | 0..1 |
| Requirements | Element |
| 18. Extension.extension:milestone.url | |
| Control | 1..1 |
| Fixed Value | milestone |
| 20. Extension.extension:milestone.value[x] | |
| Definition | The milestones the subject has passed through. |
| Short | SignedUp | Screened | Randomized |
| Comments | There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken. |
| Control | 0..1 |
| Binding | For example codes, see R5ResearchSubjectMilestoneForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-milestone-for-R4|0.1.0)Indicates the progression of a study subject through the study milestones. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 22. Extension.extension:reason | |
| Slice Name | reason |
| Definition | R5: |
| Short | R5: State change reason (new) |
| Comments | Element |
| Control | 0..1 |
| Requirements | Element |
| 24. Extension.extension:reason.url | |
| Control | 1..1 |
| Fixed Value | reason |
| 26. Extension.extension:reason.value[x] | |
| Definition | The reason for the state change. If coded it should follow the formal subject state model. |
| Short | State change reason |
| Control | 0..1 |
| Binding | For example codes, see R5StateChangeReasonForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-state-change-reason-for-R4|0.1.0)Indicates why the state of the subject changed. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 28. Extension.extension:startDate | |
| Slice Name | startDate |
| Definition | R5: |
| Short | R5: State change date (new) |
| Comments | Element |
| Control | 0..1 |
| Requirements | This was originally defined as the date when the change in status occurred. This assumed all states were recorded which is not true. Hence the need to track the end of the state. Element |
| 30. Extension.extension:startDate.url | |
| Control | 1..1 |
| Fixed Value | startDate |
| 32. Extension.extension:startDate.value[x] | |
| Definition | The date when the new status started. |
| Short | State change date |
| Comments | This is NOT the date the change in state was recorded. |
| Control | 0..1 |
| Type | dateTime |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 34. Extension.extension:endDate | |
| Slice Name | endDate |
| Definition | R5: |
| Short | R5: State change date (new) |
| Comments | Element |
| Control | 0..1 |
| Requirements | See the requirement on the start date. Element |
| 36. Extension.extension:endDate.url | |
| Control | 1..1 |
| Fixed Value | endDate |
| 38. Extension.extension:endDate.value[x] | |
| Definition | The date when the state ended. |
| Short | State change date |
| Control | 0..1 |
| Type | dateTime |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 40. Extension.url | |
| Control | 1..1 |
| Fixed Value | http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchSubject.progress |
| 42. Extension.value[x] | |
| Control | 0..0 |
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | R5: |
| Short | R5: Subject status (new) |
| Comments | Element It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording. |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Is Modifier | 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()) |
| 2. Extension.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. Extension.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..* |
| Type | Extension |
| Is Modifier | 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()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 6. Extension.extension:type | |
| Slice Name | type |
| Definition | R5: |
| Short | R5: state | milestone (new) |
| Comments | Element |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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()) |
| 8. Extension.extension:type.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 10. Extension.extension:type.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 12. Extension.extension:type.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | type |
| 14. Extension.extension:type.value[x] | |
| Definition | Identifies the aspect of the subject's journey that the state refers to. |
| Short | state | milestone |
| Control | 0..1 |
| Binding | For example codes, see R5ResearchSubjectStateTypeForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-state-type-for-R4|0.1.0)Identifies the kind of state being refered to. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. Extension.extension:subjectState | |
| Slice Name | subjectState |
| Definition | R5: |
| Short | R5: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn (new) |
| Comments | Element |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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. Extension.extension:subjectState.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 20. Extension.extension:subjectState.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 22. Extension.extension:subjectState.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | subjectState |
| 24. Extension.extension:subjectState.value[x] | |
| Definition | The current state of the subject. |
| Short | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn |
| Control | 0..1 |
| Binding | The codes SHALL be taken from R5ResearchSubjectStateForR4 (0.1.0) (required to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-state-for-R4|0.1.0)Indicates the progression of a study subject through a study. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. Extension.extension:milestone | |
| Slice Name | milestone |
| Definition | R5: |
| Short | R5: SignedUp | Screened | Randomized (new) |
| Comments | Element |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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()) |
| 28. Extension.extension:milestone.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 30. Extension.extension:milestone.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 32. Extension.extension:milestone.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | milestone |
| 34. Extension.extension:milestone.value[x] | |
| Definition | The milestones the subject has passed through. |
| Short | SignedUp | Screened | Randomized |
| Comments | There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken. |
| Control | 0..1 |
| Binding | For example codes, see R5ResearchSubjectMilestoneForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-research-subject-milestone-for-R4|0.1.0)Indicates the progression of a study subject through the study milestones. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. Extension.extension:reason | |
| Slice Name | reason |
| Definition | R5: |
| Short | R5: State change reason (new) |
| Comments | Element |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | Element |
| 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()) |
| 38. Extension.extension:reason.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 40. Extension.extension:reason.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 42. Extension.extension:reason.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | reason |
| 44. Extension.extension:reason.value[x] | |
| Definition | The reason for the state change. If coded it should follow the formal subject state model. |
| Short | State change reason |
| Control | 0..1 |
| Binding | For example codes, see R5StateChangeReasonForR4 (0.1.0) (example to http://hl7.org/fhir/uv/xver/ValueSet/R5-state-change-reason-for-R4|0.1.0)Indicates why the state of the subject changed. |
| Type | CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. Extension.extension:startDate | |
| Slice Name | startDate |
| Definition | R5: |
| Short | R5: State change date (new) |
| Comments | Element |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | This was originally defined as the date when the change in status occurred. This assumed all states were recorded which is not true. Hence the need to track the end of the state. Element |
| 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()) |
| 48. Extension.extension:startDate.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 50. Extension.extension:startDate.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 52. Extension.extension:startDate.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | startDate |
| 54. Extension.extension:startDate.value[x] | |
| Definition | The date when the new status started. |
| Short | State change date |
| Comments | This is NOT the date the change in state was recorded. |
| Control | 0..1 |
| Type | dateTime |
| [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 |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 56. Extension.extension:endDate | |
| Slice Name | endDate |
| Definition | R5: |
| Short | R5: State change date (new) |
| Comments | Element |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Requirements | See the requirement on the start date. Element |
| 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()) |
| 58. Extension.extension:endDate.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 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 60. Extension.extension:endDate.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| 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()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 62. Extension.extension:endDate.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | endDate |
| 64. Extension.extension:endDate.value[x] | |
| Definition | The date when the state ended. |
| Short | State change date |
| Control | 0..1 |
| Type | dateTime |
| [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 |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 66. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchSubject.progress |
| 68. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..0 |
| Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r5.r4#0.1.0 based on FHIR 4.0.1. Generated 2026-03-20
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