Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10 | Version: 1.1.6 | |||
Active as of 2024-09-22 | 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 | 0..* | Bundle | CMC eCTD 32S1 Bundle | |
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | Persistent identifier for the bundle |
type | S | 1..1 | code | document Required Pattern: document |
timestamp | S | 1..1 | instant | When the bundle was assembled |
Slices for entry | S | 2..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Closed by profile:resource |
entry:All Slices | Content/Rules for all slices | |||
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 |
entry:Composition | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | EctdComposition32S10 | A set of resources composed into a single coherent clinical statement with clinical attestation | |
entry:Organization | 0..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | CodedOrganization | A grouping of people or organizations with a common purpose | |
entry:StructureDefinition | 1..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | DrugSubstanceNomenclatureStructure, PolymorphicForm | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
entry:GraphicsFiles | 0..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | GraphicReference | A reference to a document | |
entry:StructureFiles | 0..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | StructureReference | A reference to a document | |
Documentation for this format |
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 |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..* | 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 | 0..1 | Identifier | Persistent identifier for the bundle |
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 |
Slices for entry | SΣC | 2..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Closed by profile:resource 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 |
entry:All Slices | Content/Rules for all slices | |||
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) |
entry:Composition | ΣC | 1..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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | EctdComposition32S10 | A set of resources composed into a single coherent clinical statement with clinical attestation | |
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) |
entry:Organization | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | CodedOrganization | A grouping of people or organizations with a common purpose | |
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) |
entry:StructureDefinition | ΣC | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | DrugSubstanceNomenclatureStructure, PolymorphicForm | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
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) |
entry:GraphicsFiles | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | GraphicReference | A reference to a document | |
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) |
entry:StructureFiles | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | StructureReference | A reference to a document | |
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.type | required | Pattern: documenthttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0 from the FHIR Standard | |
Bundle.entry.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:Composition.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:Organization.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:StructureDefinition.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:GraphicsFiles.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:StructureFiles.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from 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, Bundle.entry:Composition, Bundle.entry:Organization, Bundle.entry:StructureDefinition, Bundle.entry:GraphicsFiles, Bundle.entry:StructureFiles | 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, Bundle.entry:Composition, Bundle.entry:Organization, Bundle.entry:StructureDefinition, Bundle.entry:GraphicsFiles, Bundle.entry:StructureFiles | 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()) | |
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 | ||||
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 | 0..* | 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 | 0..1 | Identifier | Persistent identifier for the bundle | ||||
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 | ||||
Slices for entry | SΣC | 2..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Closed by profile:resource 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 | ||||
entry:All Slices | Content/Rules for all slices | |||||||
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) | ||||
entry:Composition | ΣC | 1..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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
resource | 0..1 | EctdComposition32S10 | A set of resources composed into a single coherent clinical statement with clinical attestation | |||||
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) | ||||
entry:Organization | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
resource | 0..1 | CodedOrganization | A grouping of people or organizations with a common purpose | |||||
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) | ||||
entry:StructureDefinition | ΣC | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
resource | 0..1 | DrugSubstanceNomenclatureStructure, PolymorphicForm | The detailed description of a substance, typically at a level beyond what is used for prescribing | |||||
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) | ||||
entry:GraphicsFiles | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
resource | 0..1 | GraphicReference | A reference to a document | |||||
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) | ||||
entry:StructureFiles | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | ||||
resource | 0..1 | StructureReference | A reference to a document | |||||
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-labels from the FHIR Standard | |
Bundle.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
Bundle.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
Bundle.type | required | Pattern: documenthttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0 from the FHIR Standard | |
Bundle.link.relation | required | LinkRelationTypeshttp://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0 from the FHIR Standard | |
Bundle.entry.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard | |
Bundle.entry.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:Composition.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard | |
Bundle.entry:Composition.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:Organization.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard | |
Bundle.entry:Organization.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:StructureDefinition.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard | |
Bundle.entry:StructureDefinition.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:GraphicsFiles.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard | |
Bundle.entry:GraphicsFiles.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from the FHIR Standard | |
Bundle.entry:StructureFiles.search.mode | required | SearchEntryModehttp://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 from the FHIR Standard | |
Bundle.entry:StructureFiles.request.method | required | HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0 from 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, Bundle.entry:Composition, Bundle.entry:Organization, Bundle.entry:StructureDefinition, Bundle.entry:GraphicsFiles, Bundle.entry:StructureFiles | 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, Bundle.entry:Composition, Bundle.entry:Organization, Bundle.entry:StructureDefinition, Bundle.entry:GraphicsFiles, Bundle.entry:StructureFiles | 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()) | |
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
Summary
Mandatory: 5 elements
Must-Support: 7 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from Bundle
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Bundle | 0..* | Bundle | CMC eCTD 32S1 Bundle | |
meta | ||||
profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
identifier | S | 0..1 | Identifier | Persistent identifier for the bundle |
type | S | 1..1 | code | document Required Pattern: document |
timestamp | S | 1..1 | instant | When the bundle was assembled |
Slices for entry | S | 2..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Closed by profile:resource |
entry:All Slices | Content/Rules for all slices | |||
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 |
entry:Composition | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | EctdComposition32S10 | A set of resources composed into a single coherent clinical statement with clinical attestation | |
entry:Organization | 0..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | CodedOrganization | A grouping of people or organizations with a common purpose | |
entry:StructureDefinition | 1..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | DrugSubstanceNomenclatureStructure, PolymorphicForm | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
entry:GraphicsFiles | 0..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | GraphicReference | A reference to a document | |
entry:StructureFiles | 0..* | BackboneElement | Entry in the bundle - will have a resource or information | |
resource | 0..1 | StructureReference | A reference to a document | |
Documentation for this format |
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 |
meta | Σ | 0..1 | Meta | Metadata about the resource |
profile | SΣ | 0..* | 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 | 0..1 | Identifier | Persistent identifier for the bundle |
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 |
Slices for entry | SΣC | 2..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Closed by profile:resource 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 |
entry:All Slices | Content/Rules for all slices | |||
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) |
entry:Composition | ΣC | 1..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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | EctdComposition32S10 | A set of resources composed into a single coherent clinical statement with clinical attestation | |
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) |
entry:Organization | ΣC | 0..* | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | CodedOrganization | A grouping of people or organizations with a common purpose | |
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) |
entry:StructureDefinition | ΣC | 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 | ΣC | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | 0..1 | DrugSubstanceNomenclatureStructure, PolymorphicForm | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
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 |