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: PQCMC Attachment ( Abstract )

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-attachment Version: 1.1.6
Active as of 2024-09-22 Computable Name: PqcmcAttachment
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.49

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

Usage:

Formal Views of Profile Content

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

This structure is derived from Attachment

NameFlagsCard.TypeDescription & Constraintsdoco
.. Attachment Attachment This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Attachment C 0..* Attachment This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Attachment.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
att-1errorAttachmentIf the Attachment has data, it SHALL have a contentType
: data.empty() or contentType.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
NameFlagsCard.TypeDescription & Constraintsdoco
.. Attachment C 0..* Attachment This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, 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
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Attachment.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard
Attachment.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
att-1errorAttachmentIf the Attachment has data, it SHALL have a contentType
: data.empty() or contentType.exists()
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 Attachment

Summary

Mandatory: 3 elements
Must-Support: 3 elements

Differential View

This structure is derived from Attachment

NameFlagsCard.TypeDescription & Constraintsdoco
.. Attachment Attachment This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, 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

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Attachment C 0..* Attachment This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Attachment.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
att-1errorAttachmentIf the Attachment has data, it SHALL have a contentType
: data.empty() or contentType.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Attachment C 0..* Attachment This is an abstractprofile. Childprofiles: AnalyticalInstrumentData, GraphicAttachment, 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
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Attachment.contentTyperequiredMimeTypes (a valid code from urn:ietf:bcp:13)
http://hl7.org/fhir/ValueSet/mimetypes|5.0.0
from the FHIR Standard
Attachment.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
att-1errorAttachmentIf the Attachment has data, it SHALL have a contentType
: data.empty() or contentType.exists()
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 Attachment

Summary

Mandatory: 3 elements
Must-Support: 3 elements

 

Other representations of profile: CSV, Excel, Schematron