Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23 vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/Bundle
copyright
date	2024-04-08T17:51:06+00:00	2024-12-11T13:47:08+00:00	Values Differ
description	Definition for a document bundle with the CMC eCTD 32S23 profiles.
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#US
kind	resource
name	CMCeCTDDocument32S23
publisher	HL7 International / Biomedical Research and Regulation
purpose
status	active
title	CMC eCTD 32S23 Document
type	Bundle
url	http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23
version	1.0.0-ballot	1.0.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
Bundle	C	0..*	Bundle	CMC eCTD 32S23 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-32S23: The composition must be EctdComposition32S23	C	0..*	Bundle	CMC eCTD 32S23 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	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
versionId	Σ	0..1	id	Version specific identifier					Removed this element
lastUpdated	Σ	0..1	instant	When the resource version last changed					Removed this element
source	Σ	0..1	uri	Identifies where the resource comes from					Removed this element
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to					Removed this element
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System.					Removed this element
tag	Σ	0..*	Coding	Tags applied to this resource Binding: ?? (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".					Removed this element
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set
identifier	SΣC	1..1	Identifier	Persistent identifier for the bundle	SΣC	0..1	Identifier	Persistent identifier for the bundle	Element minimum cardinalities differ: '1' vs '0'
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url					Removed this element
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .					Removed this element
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.					Removed this element
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient					Removed this element
value	ΣC	0..1	string	The value that is unique Example General: 123456					Removed this element
period	Σ	0..1	Period	Time period when id is/was valid for use					Removed this element
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)					Removed this element
type	SΣC	1..1	code	document Binding: ?? (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document	SΣC	1..1	code	document Binding: ?? (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	SΣC	1..1	instant	When the bundle was assembled
total	ΣC	0..1	unsignedInt	If search, the total number of matches	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	BackboneElement	Links related to this Bundle	ΣC	0..*	BackboneElement	Links related to this Bundle
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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: ?? (required)	ΣC	1..1	code	See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: ?? (required)
url	ΣC	1..1	uri	Reference details for the link	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	SΣC	4..*	BackboneElement	Entry in the bundle - will have a resource or information Slice: Unordered, Open 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	Element minimum cardinalities differ: '1' vs '4'
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry	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.)	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	SΣC	1..1	Resource	A resource in the bundle
search	ΣC	0..1	BackboneElement	Search related information	ΣC	0..1	BackboneElement	Search related information
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!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: ?? (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.	Σ	0..1	code	match | include - why this is in the result set Binding: ?? (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)	Σ	0..1	decimal	Search ranking (between 0 and 1)
request	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history)	ΣC	0..1	BackboneElement	Additional execution information (transaction/batch/history)
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
method	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: ?? (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details.	ΣC	1..1	code	GET | HEAD | POST | PUT | DELETE | PATCH Binding: ?? (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	Σ	1..1	uri	URL for HTTP equivalent of this entry
ifNoneMatch	Σ	0..1	string	For managing cache validation	Σ	0..1	string	For managing cache validation
ifModifiedSince	Σ	0..1	instant	For managing cache currency	Σ	0..1	instant	For managing cache currency
ifMatch	Σ	0..1	string	For managing update contention	Σ	0..1	string	For managing update contention
ifNoneExist	Σ	0..1	string	For conditional creates	Σ	0..1	string	For conditional creates
response	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)	ΣC	0..1	BackboneElement	Results of execution (transaction/batch/history)
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	Σ	1..1	string	Status response code (text optional)	Σ	1..1	string	Status response code (text optional)
location	Σ	0..1	uri	The location (if the operation returns a 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)	Σ	0..1	string	The Etag for the resource (if relevant)
lastModified	Σ	0..1	instant	Server's date time modified	Σ	0..1	instant	Server's date time modified
outcome	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)	Σ	0..1	Resource	OperationOutcome with hints and warnings (for batch/transaction)
signature	Σ	0..1	Signature	Digital Signature	Σ	0..1	Signature	Digital Signature
issues	ΣC	0..1	??	Issues with the Bundle	ΣC	0..1	??	Issues with the Bundle	Type Mismatch: Resource([CanonicalType[http://hl7.org/fhir/StructureDefinition/OperationOutcome]]) vs Resource([CanonicalType[http://hl7.org/fhir/StructureDefinition/OperationOutcome]])
Documentation for this format