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: PQCMC Attachment ( Abstract )

Any attached file in a submission is required to have a type, data, and a title

Usage:

• Derived from this DataType Constraint: Analytical Instrument Data, Analysis Graphic, Attached Document (PDF) and Structure Data
• Use this DataType Constraint: Document Reference Attachment

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 Attachment

Name	Flags	Card.	Type	Description & Constraints
Attachment			Attachment	This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, PDFAttachment, StructureDataAttachment
contentType	S	1..1	code	Mime type of the content, with charset etc.
data	S	1..1	base64Binary	Data inline, base64ed
title	S	1..1	string	Document file name including the file extension
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Attachment	C	0..*	Attachment	This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, PDFAttachment, StructureDataAttachment 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: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) 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

Terminology Bindings

Path	Conformance	ValueSet	URI
Attachment.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard

Constraints

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..*	Attachment	This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, PDFAttachment, StructureDataAttachment 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: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) 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. Additional Bindings Purpose CommonLanguages Starter Set 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

Terminology Bindings

Path	Conformance	ValueSet	URI
Attachment.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard
Attachment.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard

Constraints

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 Attachment

Summary

Mandatory: 3 elements
Must-Support: 3 elements

Differential View

This structure is derived from Attachment

Name	Flags	Card.	Type	Description & Constraints
Attachment			Attachment	This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, PDFAttachment, StructureDataAttachment
contentType	S	1..1	code	Mime type of the content, with charset etc.
data	S	1..1	base64Binary	Data inline, base64ed
title	S	1..1	string	Document file name including the file extension
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Attachment	C	0..*	Attachment	This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, PDFAttachment, StructureDataAttachment 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: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) 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

Terminology Bindings

Path	Conformance	ValueSet	URI
Attachment.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard

Constraints

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..*	Attachment	This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, PDFAttachment, StructureDataAttachment 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: MimeTypes (required): BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049) 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. Additional Bindings Purpose CommonLanguages Starter Set 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

Terminology Bindings

Path	Conformance	ValueSet	URI
Attachment.contentType	required	MimeTypes (a valid code from urn:ietf:bcp:13) http://hl7.org/fhir/ValueSet/mimetypes|5.0.0 from the FHIR Standard
Attachment.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard

Constraints

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 Attachment

Summary

Mandatory: 3 elements
Must-Support: 3 elements

Other representations of profile: CSV, Excel, Schematron