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/pqcmc-structure-data | Version: 1.1.6 | |||
Active as of 2024-09-22 | Computable Name: StructureDataAttachment | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.58 |
Any attached file that contains structure data (e.g. SDFiles, MolFiles, INCHI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PqcmcAttachment
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Attachment | PqcmcAttachment | This is an abstractprofile. | ||
contentType | 1..1 | code | Mime type of the content, with charset etc. Binding: Structure Data Types (required) | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Attachment.contentType | required | PqcmcStructureDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-structure-data-types from this IG |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Attachment | C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType |
contentType | SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Structure Data Types (required) Example General: text/plain; charset=UTF-8, image/png |
data | SC | 1..1 | base64Binary | Data inline, base64ed |
title | SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Attachment.contentType | required | PqcmcStructureDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-structure-data-types from this IG |
Id | Grade | Path(s) | Details | Requirements |
att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Attachment | C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
contentType | SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Structure Data Types (required) Example General: text/plain; charset=UTF-8, image/png | ||||
language | Σ | 0..1 | code | Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language.
Example General: en-AU | ||||
data | SC | 1..1 | base64Binary | Data inline, base64ed | ||||
url | Σ | 0..1 | url | Uri where the data can be found Example General: http://www.acme.com/logo-small.png | ||||
size | Σ | 0..1 | integer64 | Number of bytes of content (if url provided) | ||||
hash | Σ | 0..1 | base64Binary | Hash of the data (sha-1, base64ed) | ||||
title | SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo | ||||
creation | Σ | 0..1 | dateTime | Date attachment was first created | ||||
height | 0..1 | positiveInt | Height of the image in pixels (photo/video) | |||||
width | 0..1 | positiveInt | Width of the image in pixels (photo/video) | |||||
frames | 0..1 | positiveInt | Number of frames if > 1 (photo) | |||||
duration | 0..1 | decimal | Length in seconds (audio / video) | |||||
pages | 0..1 | positiveInt | Number of printed pages | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
Attachment.contentType | required | PqcmcStructureDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-structure-data-types from this IG | |
Attachment.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.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 PqcmcAttachment
Differential View
This structure is derived from PqcmcAttachment
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Attachment | PqcmcAttachment | This is an abstractprofile. | ||
contentType | 1..1 | code | Mime type of the content, with charset etc. Binding: Structure Data Types (required) | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Attachment.contentType | required | PqcmcStructureDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-structure-data-types from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Attachment | C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType |
contentType | SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Structure Data Types (required) Example General: text/plain; charset=UTF-8, image/png |
data | SC | 1..1 | base64Binary | Data inline, base64ed |
title | SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Attachment.contentType | required | PqcmcStructureDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-structure-data-types from this IG |
Id | Grade | Path(s) | Details | Requirements |
att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
Attachment | C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
contentType | SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Structure Data Types (required) Example General: text/plain; charset=UTF-8, image/png | ||||
language | Σ | 0..1 | code | Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language.
Example General: en-AU | ||||
data | SC | 1..1 | base64Binary | Data inline, base64ed | ||||
url | Σ | 0..1 | url | Uri where the data can be found Example General: http://www.acme.com/logo-small.png | ||||
size | Σ | 0..1 | integer64 | Number of bytes of content (if url provided) | ||||
hash | Σ | 0..1 | base64Binary | Hash of the data (sha-1, base64ed) | ||||
title | SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo | ||||
creation | Σ | 0..1 | dateTime | Date attachment was first created | ||||
height | 0..1 | positiveInt | Height of the image in pixels (photo/video) | |||||
width | 0..1 | positiveInt | Width of the image in pixels (photo/video) | |||||
frames | 0..1 | positiveInt | Number of frames if > 1 (photo) | |||||
duration | 0..1 | decimal | Length in seconds (audio / video) | |||||
pages | 0..1 | positiveInt | Number of printed pages | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
Attachment.contentType | required | PqcmcStructureDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-structure-data-types from this IG | |
Attachment.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.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 PqcmcAttachment
Other representations of profile: CSV, Excel, Schematron