Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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

## Data Type Profile: Literal Reference ( Abstract )

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: LiteralReference
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.63

An abstract profile to ensure the reference is always a literal reference. Used in conjunction with a rule set to ensure every reference is also bundled.

Usages:

- Use this DataType Profile: ContainerClosure, eCTD Product Description and Composition, eCTD Batch Formula, eCTD Product Characterisation of Impurities... Show 15 more, eCTD Substance General Information, eCTD Substance Control of Materials, eCTD Substance Characterisation, eCTD Specification, Literal Coded Reference, Batch Formula Drug Product Identification, Component Substance, Drug Substance Impurity, Drug Substance, Substance General Information, Excipient Drug Substance, Polymorphic Form, Drug Product Batch Formula, Quality Specification and Drug Substance Handle

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Reference | C | 0..* | Reference | This is an abstract profile. A reference from one resource to another Constraints: ref-1, ref-2
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ref-1 | error | Reference | SHALL have a contained resource if a local reference is provided : reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource)) |
ref-2 | error | Reference | At least one of reference, identifier and display SHALL be present (unless an extension is provided). : reference.exists() or identifier.exists() or display.exists() or extension.exists() |

This structure is derived from Reference

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Reference |  |  | Reference | This is an abstract profile.
reference | S | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Reference | C | 0..* | Reference | This is an abstract profile. A reference from one resource to another Constraints: ref-1, ref-2
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | Σ C | 0..1 | Identifier | Logical reference, when literal reference is not known
display | Σ C | 0..1 | string | Text alternative for the resource
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Reference.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
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() |
ref-1 | error | Reference | SHALL have a contained resource if a local reference is provided : reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource)) |
ref-2 | error | Reference | At least one of reference, identifier and display SHALL be present (unless an extension is provided). : reference.exists() or identifier.exists() or display.exists() or extension.exists() |

This structure is derived from Reference

Summary

Mandatory: 1 element
Must-Support: 1 element

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Reference | C | 0..* | Reference | This is an abstract profile. A reference from one resource to another Constraints: ref-1, ref-2
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ref-1 | error | Reference | SHALL have a contained resource if a local reference is provided : reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource)) |
ref-2 | error | Reference | At least one of reference, identifier and display SHALL be present (unless an extension is provided). : reference.exists() or identifier.exists() or display.exists() or extension.exists() |

Differential View

This structure is derived from Reference

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Reference |  |  | Reference | This is an abstract profile.
reference | S | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Reference | C | 0..* | Reference | This is an abstract profile. A reference from one resource to another Constraints: ref-1, ref-2
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | Σ C | 0..1 | Identifier | Logical reference, when literal reference is not known
display | Σ C | 0..1 | string | Text alternative for the resource
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Reference.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
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() |
ref-1 | error | Reference | SHALL have a contained resource if a local reference is provided : reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource)) |
ref-2 | error | Reference | At least one of reference, identifier and display SHALL be present (unless an extension is provided). : reference.exists() or identifier.exists() or display.exists() or extension.exists() |

This structure is derived from Reference

Summary

Mandatory: 1 element
Must-Support: 1 element

Maturity: 2

Other representations of profile: CSV, Excel, Schematron