Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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

Data Type Profile: PqAddress

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-cmc-address Version: 1.1.6
Active as of 2024-09-22 Computable Name: PqAddress
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.15

pq-specific Constraints on the Address datatype dealing with US addresses.

Usage:

Formal Views of Profile Content

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

This structure is derived from Address

NameFlagsCard.TypeDescription & Constraintsdoco
.. Address C 0..* Address An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
... type S 1..1 code postal | physical | both
... line 1..2 string Street name, number, direction & P.O. Box etc.
... city S 1..1 string Name of city, town etc.
... postalCode S 1..1 string Postal code for area
... country SC 1..1 string Country must be a 3-letter country code.
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorAddressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorAddressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3errorAddress.countryCountry must be a 3 letter country code
: $this.length() = 3
NameFlagsCard.TypeDescription & Constraintsdoco
.. Address C 0..* Address An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
... use ?!Σ 0..1 code home | work | temp | old | billing - purpose of this address
Binding: AddressUse (required): The use of an address (home / work / etc.).


Example General: home
... type SΣ 1..1 code postal | physical | both
Binding: AddressType (required): The type of an address (physical / postal).


Example General: both
... line Σ 1..2 string Street name, number, direction & P.O. Box etc.
This repeating element order: The order in which lines should appear in an address label
Example General: 137 Nowhere Street
... state SΣ 0..1 string Sub-unit of country (abbreviations ok)
... postalCode SΣ 1..1 string Postal code for area
Example General: 9132
... country SΣC 1..1 string Country must be a 3-letter country code.
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Address.userequiredAddressUse
http://hl7.org/fhir/ValueSet/address-use|5.0.0
from the FHIR Standard
Address.typerequiredAddressType
http://hl7.org/fhir/ValueSet/address-type|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorAddressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorAddressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3errorAddress.countryCountry must be a 3 letter country code
: $this.length() = 3
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
NameFlagsCard.TypeDescription & Constraintsdoco
.. Address C 0..* Address An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
... id 0..1 id Unique id for inter-element referencing
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... use ?!Σ 0..1 code home | work | temp | old | billing - purpose of this address
Binding: AddressUse (required): The use of an address (home / work / etc.).


Example General: home
... text Σ 0..1 string Text representation of the address
Example General: 137 Nowhere Street, Erewhon 9132
... line Σ 1..2 string Street name, number, direction & P.O. Box etc.
This repeating element order: The order in which lines should appear in an address label
Example General: 137 Nowhere Street
... city SΣ 1..1 string Name of city, town etc.
Example General: Erewhon
... district Σ 0..1 string District name (aka county)
Example General: Madison
... state SΣ 0..1 string Sub-unit of country (abbreviations ok)
... postalCode SΣ 1..1 string Postal code for area
Example General: 9132
... country SΣC 1..1 string Country must be a 3-letter country code.
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
... period Σ 0..1 Period Time period when address was/is in use
Example General: {"start":"2010-03-23","end":"2010-07-01"}

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Address.userequiredAddressUse
http://hl7.org/fhir/ValueSet/address-use|5.0.0
from the FHIR Standard
Address.typerequiredAddressType
http://hl7.org/fhir/ValueSet/address-type|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorAddressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorAddressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3errorAddress.countryCountry must be a 3 letter country code
: $this.length() = 3
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Address

Summary

Mandatory: 5 elements
Must-Support: 5 elements

Differential View

This structure is derived from Address

NameFlagsCard.TypeDescription & Constraintsdoco
.. Address C 0..* Address An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
... type S 1..1 code postal | physical | both
... line 1..2 string Street name, number, direction & P.O. Box etc.
... city S 1..1 string Name of city, town etc.
... postalCode S 1..1 string Postal code for area
... country SC 1..1 string Country must be a 3-letter country code.
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorAddressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorAddressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3errorAddress.countryCountry must be a 3 letter country code
: $this.length() = 3

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Address C 0..* Address An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
... use ?!Σ 0..1 code home | work | temp | old | billing - purpose of this address
Binding: AddressUse (required): The use of an address (home / work / etc.).


Example General: home
... type SΣ 1..1 code postal | physical | both
Binding: AddressType (required): The type of an address (physical / postal).


Example General: both
... line Σ 1..2 string Street name, number, direction & P.O. Box etc.
This repeating element order: The order in which lines should appear in an address label
Example General: 137 Nowhere Street
... state SΣ 0..1 string Sub-unit of country (abbreviations ok)
... postalCode SΣ 1..1 string Postal code for area
Example General: 9132
... country SΣC 1..1 string Country must be a 3-letter country code.
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Address.userequiredAddressUse
http://hl7.org/fhir/ValueSet/address-use|5.0.0
from the FHIR Standard
Address.typerequiredAddressType
http://hl7.org/fhir/ValueSet/address-type|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorAddressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorAddressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3errorAddress.countryCountry must be a 3 letter country code
: $this.length() = 3
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Address C 0..* Address An address expressed using postal conventions (as opposed to GPS or other location definition formats)
addr-state: If the country is USA, then the state and postal code exist
addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
... id 0..1 id Unique id for inter-element referencing
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... use ?!Σ 0..1 code home | work | temp | old | billing - purpose of this address
Binding: AddressUse (required): The use of an address (home / work / etc.).


Example General: home
... text Σ 0..1 string Text representation of the address
Example General: 137 Nowhere Street, Erewhon 9132
... line Σ 1..2 string Street name, number, direction & P.O. Box etc.
This repeating element order: The order in which lines should appear in an address label
Example General: 137 Nowhere Street
... city SΣ 1..1 string Name of city, town etc.
Example General: Erewhon
... district Σ 0..1 string District name (aka county)
Example General: Madison
... state SΣ 0..1 string Sub-unit of country (abbreviations ok)
... postalCode SΣ 1..1 string Postal code for area
Example General: 9132
... country SΣC 1..1 string Country must be a 3-letter country code.
cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
... period Σ 0..1 Period Time period when address was/is in use
Example General: {"start":"2010-03-23","end":"2010-07-01"}

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Address.userequiredAddressUse
http://hl7.org/fhir/ValueSet/address-use|5.0.0
from the FHIR Standard
Address.typerequiredAddressType
http://hl7.org/fhir/ValueSet/address-type|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
addr-stateerrorAddressIf the country is USA, then the state and postal code exist
: country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-ziperrorAddressIf the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
: country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3errorAddress.countryCountry must be a 3 letter country code
: $this.length() = 3
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Address

Summary

Mandatory: 5 elements
Must-Support: 5 elements

 

Other representations of profile: CSV, Excel, Schematron