Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10 | Version: 1.0.0-ballot | |||
| Active as of 2024-04-08 | Computable Name: CMCeCTDDocument32S10 | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.3 | ||||
Definition for a document bundle with the CMC eCTD 32S1 profiles.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Bundle
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Bundle |
C | 0..* | Bundle | CMC eCTD 32S1 Bundle cmc-identifer: A document must have an identifier with a system and a value cmc-32S10: The composition must be EctdComposition32S10 |
  meta |
||||
  profile |
S | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| identifier |
S | 1..1 | Identifier | Persistent identifier for the bundle |
  extension |
1..* | Extension | Extension | |
 version |
S | 1..1 | string | IG Version URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version |
| type |
S | 1..1 | code | document Required Pattern: document |
| timestamp |
S | 1..1 | instant | When the bundle was assembled |
 entry |
S | 1..* | BackboneElement | Entry in the bundle - will have a resource or information |
 fullUrl |
S | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource |
S | 1..1 | Resource | A resource in the bundle |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| cmc-32S10 | error | Bundle | The composition must be EctdComposition32S10 : entry.select(resource as Composition).where(type.exists(coding.exists(code='32S10'))).exists() | |
| cmc-identifer | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.exists(system.exists() and value.exists())) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | CMC eCTD 32S1 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements cmc-identifer: A document must have an identifier with a system and a value cmc-32S10: The composition must be EctdComposition32S10 |
 meta |
Σ | 0..1 | Meta | Metadata about the resource |
 profile |
SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| identifier |
SΣC | 1..1 | Identifier | Persistent identifier for the bundle |
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| version |
S | 1..1 | string | IG Version URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
SΣC | 1..1 | code | document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document |
| timestamp |
SΣC | 1..1 | instant | When the bundle was assembled |
| entry |
SΣC | 1..* | BackboneElement | Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| fullUrl |
SΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource |
SΣC | 1..1 | Resource | A resource in the bundle |
| request |
ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method |
ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url |
Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response |
ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status |
Σ | 1..1 | string | Status response code (text optional) |
| issues |
ΣC | 0..1 | OperationOutcome | Issues with the Bundle |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Bundle.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| Bundle.type | required | Pattern: documenthttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0from the FHIR Standard | |
| Bundle.entry.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| bdl-1 | error | Bundle | total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history') | |
| bdl-2 | error | Bundle | entry.search only when a search : (type = 'searchset') or entry.search.empty() | |
| bdl-5 | error | Bundle.entry | must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists() | |
| bdl-7 | error | Bundle | FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct() | |
| bdl-8 | error | Bundle.entry | fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not() | |
| bdl-9 | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists()) | |
| bdl-10 | error | Bundle | A document must have a date : type = 'document' implies (timestamp.hasValue()) | |
| bdl-11 | error | Bundle | A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition) | |
| bdl-12 | error | Bundle | A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader) | |
| bdl-13 | error | Bundle | A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus) | |
| bdl-14 | error | Bundle | entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH' | |
| bdl-15 | error | Bundle | Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST') | |
| bdl-16 | error | Bundle | Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning') | |
| bdl-17 | error | Bundle | Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty() | |
| bdl-18 | error | Bundle | Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists() | |
| bdl-3a | error | Bundle | For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty()) | |
| bdl-3b | error | Bundle | For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3c | error | Bundle | For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3d | error | Bundle | For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists()) | |
| cmc-32S10 | error | Bundle | The composition must be EctdComposition32S10 : entry.select(resource as Composition).where(type.exists(coding.exists(code='32S10'))).exists() | |
| cmc-identifer | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.exists(system.exists() and value.exists())) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | CMC eCTD 32S1 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements cmc-identifer: A document must have an identifier with a system and a value cmc-32S10: The composition must be EctdComposition32S10 | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| versionId |
Σ | 0..1 | id | Version specific identifier | ||||
| lastUpdated |
Σ | 0..1 | instant | When the resource version last changed | ||||
| source |
Σ | 0..1 | uri | Identifies where the resource comes from | ||||
| profile |
SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
| security |
Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| tag |
Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| identifier |
SΣC | 1..1 | Identifier | Persistent identifier for the bundle | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| version |
S | 1..1 | string | IG Version URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version | ||||
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
| system |
Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
 assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| type |
SΣC | 1..1 | code | document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document | ||||
| timestamp |
SΣC | 1..1 | instant | When the bundle was assembled | ||||
| total |
ΣC | 0..1 | unsignedInt | If search, the total number of matches | ||||
| link |
ΣC | 0..* | BackboneElement | Links related to this Bundle | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| relation |
ΣC | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) | ||||
| url |
ΣC | 1..1 | uri | Reference details for the link | ||||
| entry |
SΣC | 1..* | BackboneElement | Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| link |
Σ | 0..* | See link (Bundle) | Links related to this entry | ||||
| fullUrl |
SΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
| resource |
SΣC | 1..1 | Resource | A resource in the bundle | ||||
| search |
ΣC | 0..1 | BackboneElement | Search related information | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| mode |
Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process. | ||||
| score |
Σ | 0..1 | decimal | Search ranking (between 0 and 1) | ||||
| request |
ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| method |
ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. | ||||
| url |
Σ | 1..1 | uri | URL for HTTP equivalent of this entry | ||||
| ifNoneMatch |
Σ | 0..1 | string | For managing cache validation | ||||
| ifModifiedSince |
Σ | 0..1 | instant | For managing cache currency | ||||
| ifMatch |
Σ | 0..1 | string | For managing update contention | ||||
| ifNoneExist |
Σ | 0..1 | string | For conditional creates | ||||
| response |
ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| status |
Σ | 1..1 | string | Status response code (text optional) | ||||
| location |
Σ | 0..1 | uri | The location (if the operation returns a location) | ||||
| etag |
Σ | 0..1 | string | The Etag for the resource (if relevant) | ||||
| lastModified |
Σ | 0..1 | instant | Server's date time modified | ||||
| outcome |
Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) | ||||
| signature |
Σ | 0..1 | Signature | Digital Signature | ||||
| issues |
ΣC | 0..1 | OperationOutcome | Issues with the Bundle | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| Bundle.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| Bundle.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| Bundle.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Bundle.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| Bundle.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| Bundle.type | required | Pattern: documenthttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0from the FHIR Standard | |
| Bundle.link.relation | required | LinkRelationTypeshttp://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0from the FHIR Standard | |
| Bundle.entry.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0from the FHIR Standard | |
| Bundle.entry.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| bdl-1 | error | Bundle | total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history') | |
| bdl-2 | error | Bundle | entry.search only when a search : (type = 'searchset') or entry.search.empty() | |
| bdl-5 | error | Bundle.entry | must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists() | |
| bdl-7 | error | Bundle | FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct() | |
| bdl-8 | error | Bundle.entry | fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not() | |
| bdl-9 | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists()) | |
| bdl-10 | error | Bundle | A document must have a date : type = 'document' implies (timestamp.hasValue()) | |
| bdl-11 | error | Bundle | A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition) | |
| bdl-12 | error | Bundle | A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader) | |
| bdl-13 | error | Bundle | A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus) | |
| bdl-14 | error | Bundle | entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH' | |
| bdl-15 | error | Bundle | Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST') | |
| bdl-16 | error | Bundle | Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning') | |
| bdl-17 | error | Bundle | Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty() | |
| bdl-18 | error | Bundle | Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists() | |
| bdl-3a | error | Bundle | For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty()) | |
| bdl-3b | error | Bundle | For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3c | error | Bundle | For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3d | error | Bundle | For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists()) | |
| cmc-32S10 | error | Bundle | The composition must be EctdComposition32S10 : entry.select(resource as Composition).where(type.exists(coding.exists(code='32S10'))).exists() | |
| cmc-identifer | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.exists(system.exists() and value.exists())) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Bundle
Differential View
This structure is derived from Bundle
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | CMC eCTD 32S1 Bundle cmc-identifer: A document must have an identifier with a system and a value cmc-32S10: The composition must be EctdComposition32S10 |
| meta |
||||
| profile |
S | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| identifier |
S | 1..1 | Identifier | Persistent identifier for the bundle |
| extension |
1..* | Extension | Extension | |
| version |
S | 1..1 | string | IG Version URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version |
| type |
S | 1..1 | code | document Required Pattern: document |
| timestamp |
S | 1..1 | instant | When the bundle was assembled |
| entry |
S | 1..* | BackboneElement | Entry in the bundle - will have a resource or information |
| fullUrl |
S | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource |
S | 1..1 | Resource | A resource in the bundle |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| cmc-32S10 | error | Bundle | The composition must be EctdComposition32S10 : entry.select(resource as Composition).where(type.exists(coding.exists(code='32S10'))).exists() | |
| cmc-identifer | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.exists(system.exists() and value.exists())) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | CMC eCTD 32S1 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements cmc-identifer: A document must have an identifier with a system and a value cmc-32S10: The composition must be EctdComposition32S10 |
| meta |
Σ | 0..1 | Meta | Metadata about the resource |
| profile |
SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| identifier |
SΣC | 1..1 | Identifier | Persistent identifier for the bundle |
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| version |
S | 1..1 | string | IG Version URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
SΣC | 1..1 | code | document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document |
| timestamp |
SΣC | 1..1 | instant | When the bundle was assembled |
| entry |
SΣC | 1..* | BackboneElement | Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| fullUrl |
SΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource |
SΣC | 1..1 | Resource | A resource in the bundle |
| request |
ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method |
ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url |
Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response |
ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status |
Σ | 1..1 | string | Status response code (text optional) |
| issues |
ΣC | 0..1 | OperationOutcome | Issues with the Bundle |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Bundle.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| Bundle.type | required | Pattern: documenthttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0from the FHIR Standard | |
| Bundle.entry.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| bdl-1 | error | Bundle | total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history') | |
| bdl-2 | error | Bundle | entry.search only when a search : (type = 'searchset') or entry.search.empty() | |
| bdl-5 | error | Bundle.entry | must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists() | |
| bdl-7 | error | Bundle | FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct() | |
| bdl-8 | error | Bundle.entry | fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not() | |
| bdl-9 | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists()) | |
| bdl-10 | error | Bundle | A document must have a date : type = 'document' implies (timestamp.hasValue()) | |
| bdl-11 | error | Bundle | A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition) | |
| bdl-12 | error | Bundle | A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader) | |
| bdl-13 | error | Bundle | A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus) | |
| bdl-14 | error | Bundle | entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH' | |
| bdl-15 | error | Bundle | Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST') | |
| bdl-16 | error | Bundle | Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning') | |
| bdl-17 | error | Bundle | Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty() | |
| bdl-18 | error | Bundle | Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists() | |
| bdl-3a | error | Bundle | For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty()) | |
| bdl-3b | error | Bundle | For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3c | error | Bundle | For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3d | error | Bundle | For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists()) | |
| cmc-32S10 | error | Bundle | The composition must be EctdComposition32S10 : entry.select(resource as Composition).where(type.exists(coding.exists(code='32S10'))).exists() | |
| cmc-identifer | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.exists(system.exists() and value.exists())) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Bundle |
C | 0..* | Bundle | CMC eCTD 32S1 Bundle bdl-1: total only when a search or history bdl-2: entry.search only when a search bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) bdl-9: A document must have an identifier with a system and a value bdl-10: A document must have a date bdl-11: A document must have a Composition as the first resource bdl-12: A message must have a MessageHeader as the first resource bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource bdl-14: entry.request.method PATCH not allowed for history bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. bdl-18: Self link is required for searchsets. bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements cmc-identifer: A document must have an identifier with a system and a value cmc-32S10: The composition must be EctdComposition32S10 | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| versionId |
Σ | 0..1 | id | Version specific identifier | ||||
| lastUpdated |
Σ | 0..1 | instant | When the resource version last changed | ||||
| source |
Σ | 0..1 | uri | Identifies where the resource comes from | ||||
| profile |
SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
| security |
Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| tag |
Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| identifier |
SΣC | 1..1 | Identifier | Persistent identifier for the bundle | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| version |
S | 1..1 | string | IG Version URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version | ||||
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
| system |
Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| type |
SΣC | 1..1 | code | document Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document | ||||
| timestamp |
SΣC | 1..1 | instant | When the bundle was assembled | ||||
| total |
ΣC | 0..1 | unsignedInt | If search, the total number of matches | ||||
| link |
ΣC | 0..* | BackboneElement | Links related to this Bundle | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| relation |
ΣC | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required) | ||||
| url |
ΣC | 1..1 | uri | Reference details for the link | ||||
| entry |
SΣC | 1..* | BackboneElement | Entry in the bundle - will have a resource or information bdl-5: must be a resource unless there's a request or response bdl-8: fullUrl cannot be a version specific reference This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| link |
Σ | 0..* | See link (Bundle) | Links related to this entry | ||||
| fullUrl |
SΣC | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
| resource |
SΣC | 1..1 | Resource | A resource in the bundle | ||||
| search |
ΣC | 0..1 | BackboneElement | Search related information | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| mode |
Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process. | ||||
| score |
Σ | 0..1 | decimal | Search ranking (between 0 and 1) | ||||
| request |
ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| method |
ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. | ||||
| url |
Σ | 1..1 | uri | URL for HTTP equivalent of this entry | ||||
| ifNoneMatch |
Σ | 0..1 | string | For managing cache validation | ||||
| ifModifiedSince |
Σ | 0..1 | instant | For managing cache currency | ||||
| ifMatch |
Σ | 0..1 | string | For managing update contention | ||||
| ifNoneExist |
Σ | 0..1 | string | For conditional creates | ||||
| response |
ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| status |
Σ | 1..1 | string | Status response code (text optional) | ||||
| location |
Σ | 0..1 | uri | The location (if the operation returns a location) | ||||
| etag |
Σ | 0..1 | string | The Etag for the resource (if relevant) | ||||
| lastModified |
Σ | 0..1 | instant | Server's date time modified | ||||
| outcome |
Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) | ||||
| signature |
Σ | 0..1 | Signature | Digital Signature | ||||
| issues |
ΣC | 0..1 | OperationOutcome | Issues with the Bundle | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| Bundle.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| Bundle.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| Bundle.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Bundle.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| Bundle.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| Bundle.type | required | Pattern: documenthttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0from the FHIR Standard | |
| Bundle.link.relation | required | LinkRelationTypeshttp://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0from the FHIR Standard | |
| Bundle.entry.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0from the FHIR Standard | |
| Bundle.entry.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| bdl-1 | error | Bundle | total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history') | |
| bdl-2 | error | Bundle | entry.search only when a search : (type = 'searchset') or entry.search.empty() | |
| bdl-5 | error | Bundle.entry | must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists() | |
| bdl-7 | error | Bundle | FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) : (type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct() | |
| bdl-8 | error | Bundle.entry | fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not() | |
| bdl-9 | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists()) | |
| bdl-10 | error | Bundle | A document must have a date : type = 'document' implies (timestamp.hasValue()) | |
| bdl-11 | error | Bundle | A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition) | |
| bdl-12 | error | Bundle | A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader) | |
| bdl-13 | error | Bundle | A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus) | |
| bdl-14 | error | Bundle | entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH' | |
| bdl-15 | error | Bundle | Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated : type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST') | |
| bdl-16 | error | Bundle | Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. : issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning') | |
| bdl-17 | error | Bundle | Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. : type = 'document' implies issues.empty() | |
| bdl-18 | error | Bundle | Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists() | |
| bdl-3a | error | Bundle | For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements : type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty()) | |
| bdl-3b | error | Bundle | For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH : type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3c | error | Bundle | For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH : type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())) | |
| bdl-3d | error | Bundle | For collections of type transaction-response or batch-response, all entries must contain response elements : type in ('transaction-response' | 'batch-response') implies entry.all(response.exists()) | |
| cmc-32S10 | error | Bundle | The composition must be EctdComposition32S10 : entry.select(resource as Composition).where(type.exists(coding.exists(code='32S10'))).exists() | |
| cmc-identifer | error | Bundle | A document must have an identifier with a system and a value : type = 'document' implies (identifier.exists(system.exists() and value.exists())) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Bundle
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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