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-ballot 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

• Content
• Detailed Descriptions
• XML
• JSON

Data Type Profile: Literal Reference ( Abstract )

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

Usage:

• Use this DataType Constraint: ContainerClosure, eCTD Product Description and Composition, eCTD Batch Formula, eCTD Product Characterisation of Impurities Composition... Show 15 more, eCTD Substance General Information, eCTD Substance Control of Materials Composition, eCTD Substance Characterisation, eCTD Specification Composition, 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.

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

This structure is derived from Reference

Name	Flags	Card.	Type	Description & Constraints
Reference			Reference	This is an abstractprofile.
reference	S	1..1	string	Literal reference, Relative, internal or absolute URL
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Reference	C	0..*	Reference	This is an abstractprofile. A reference from one resource to another ref-1: SHALL have a contained resource if a local reference is provided ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
reference	SΣC	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()

Name	Flags	Card.	Type	Description & Constraints
Reference	C	0..*	Reference	This is an abstractprofile. A reference from one resource to another ref-1: SHALL have a contained resource if a local reference is provided ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
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	SΣC	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	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	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

Differential View

This structure is derived from Reference

Name	Flags	Card.	Type	Description & Constraints
Reference			Reference	This is an abstractprofile.
reference	S	1..1	string	Literal reference, Relative, internal or absolute URL
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Reference	C	0..*	Reference	This is an abstractprofile. A reference from one resource to another ref-1: SHALL have a contained resource if a local reference is provided ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
reference	SΣC	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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Reference	C	0..*	Reference	This is an abstractprofile. A reference from one resource to another ref-1: SHALL have a contained resource if a local reference is provided ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided).
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	SΣC	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	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	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

Other representations of profile: CSV, Excel, Schematron