## Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10 vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10

Left: | CMC eCTD 32P10 Document (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10)
Right: | CMC eCTD 32P10 Document (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10)

### Messages

Error | StructureDefinition.version | Values for version differ: '2.0.0-ballot' vs '2.0.0'
Information | StructureDefinition.date | Values for date differ: '2024-12-12T19:00:52+00:00' vs '2025-07-03T13:07:08+00:00'
Error | Bundle.issues | Type Mismatch: Resource([CanonicalType[http://hl7.org/fhir/StructureDefinition/OperationOutcome]]) vs Resource([CanonicalType[http://hl7.org/fhir/StructureDefinition/OperationOutcome]])

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/Bundle |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+00:00 | Values Differ
description | Definition for a document bundle with the CMC eCTD 32P1 profiles. | Definition for a document bundle with the CMC eCTD 32P1 profiles (Description and Composition of the Drug Product). | Values Differ
experimental |  |
fhirVersion | 5.0.0 |
jurisdiction |  |
jurisdiction[0] | urn:iso:std:iso:3166#US |
kind | resource |
name | CMCeCTDDocument32P10 |
publisher | HL7 International / Biomedical Research and Regulation |
purpose |  |
status | active |
title | CMC eCTD 32P10 Document |
type | Bundle |
url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10 |
version | 2.0.0-ballot | 2.0.0 | 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 32P1 Bundle | C | 0..* | Bundle | CMC eCTD 32P1 Bundle |
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 |
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
|  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
identifier | S Σ C | 0..1 | Identifier | Persistent identifier for the bundle | S Σ C | 0..1 | Identifier | Persistent identifier for the bundle |
type | S Σ C | 1..1 | code | document Binding: ?? (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document | S Σ C | 1..1 | code | document Binding: ?? (required): Indicates the purpose of a bundle - how it is intended to be used. Required Pattern: document |
timestamp | S Σ C | 1..1 | instant | When the bundle was assembled | S Σ C | 1..1 | instant | When the bundle was assembled |
total | Σ C | 0..1 | unsignedInt | If search, the total number of matches | Σ C | 0..1 | unsignedInt | If search, the total number of matches |
link | Σ C | 0..* | BackboneElement | Links related to this Bundle | Σ C | 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 | Σ C | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: ?? (required) | Σ C | 1..1 | code | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: ?? (required) |
url | Σ C | 1..1 | uri | Reference details for the link | Σ C | 1..1 | uri | Reference details for the link |
Slices for entry | S Σ C | 4..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource 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 | S Σ C | 4..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Open by profile:resource 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 |  | 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 | S Σ C | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) | S Σ C | 1..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
resource | S Σ C | 1..1 | Resource | A resource in the bundle | S Σ C | 1..1 | Resource | A resource in the bundle |
search | Σ C | 0..1 | BackboneElement | Search related information | Σ C | 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 | Σ C | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) | Σ C | 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 | Σ C | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: ?? (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. | Σ C | 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 | Σ C | 0..1 | BackboneElement | Results of execution (transaction/batch/history) | Σ C | 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 | Σ C | 0..1 | ?? | Issues with the Bundle | Σ C | 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