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

Data Type Profile: AnalyticalInstrumentData - Detailed Descriptions

Active as of 2024-12-04

Definitions for the pqcmc-analytical-intstrument-data data type profile.

Guidance on how to interpret the contents of this table can be found here

0. Attachment
2. Attachment.contentType
BindingThe codes SHALL be taken from Analytical Instrument Data File Types
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-types)

Guidance on how to interpret the contents of this table can be found here

0. Attachment
Definition

For referring to data content defined in other formats.

ShortContent in a format defined elsewhere
Comments

When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent".

Control0..*
Is Modifierfalse
Invariantsatt-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2. Attachment.contentType
Definition

Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.

ShortMime type of the content, with charset etc.
Control10..1
This element is affected by the following invariants: att-1
BindingThe codes SHALL be taken from Analytical Instrument Data File Typeshttp://hl7.org/fhir/ValueSet/mimetypes|5.0.0
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-types)
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Processors of the data need to be able to know how to interpret the data.

Example<br/><b>General</b>:text/plain; charset=UTF-8, image/png
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Attachment.data
Definition

The actual data of the attachment - a sequence of bytes, base64 encoded.

ShortData inline, base64ed
Comments

The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.

Control10..1
This element is affected by the following invariants: att-1
Typebase64Binary
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Requirements

The data needs to able to be transmitted inline.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Attachment.title
Definition

A format or abbreviation name that identifies a file structure. [Source: SME Defined] Used for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic.


A label or set of text to display in place of the data.

ShortDocument file name including the file extensionLabel to display in place of the data
Comments

May sometimes be derived from the source filename.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.

Example<br/><b>General</b>:Official Corporate Logo
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. Attachment
Definition

For referring to data content defined in other formats.

ShortContent in a format defined elsewhere
Comments

When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent".

Control0..*
Is Modifierfalse
Invariantsatt-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2. Attachment.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
4. Attachment.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Attachment.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 6. Attachment.contentType
    Definition

    Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.

    ShortMime type of the content, with charset etc.
    Control1..1
    This element is affected by the following invariants: att-1
    BindingThe codes SHALL be taken from Analytical Instrument Data File Types
    (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-types)
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Processors of the data need to be able to know how to interpret the data.

    Example<br/><b>General</b>:text/plain; charset=UTF-8, image/png
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. Attachment.language
    Definition

    The human language of the content. The value can be any valid value according to BCP 47.

    ShortHuman language of the content (BCP-47)
    Control0..1
    BindingThe codes SHALL be taken from AllLanguages
    (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

    IETF language tag for a human language.

    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Users need to be able to choose between the languages in a set of attachments.

    Example<br/><b>General</b>:en-AU
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Attachment.data
    Definition

    The actual data of the attachment - a sequence of bytes, base64 encoded.

    ShortData inline, base64ed
    Comments

    The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.

    Control1..1
    This element is affected by the following invariants: att-1
    Typebase64Binary
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summaryfalse
    Requirements

    The data needs to able to be transmitted inline.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Attachment.url
    Definition

    A location where the data can be accessed.

    ShortUri where the data can be found
    Comments

    If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.

    Control0..1
    Typeurl
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    The data needs to be transmitted by reference.

    Example<br/><b>General</b>:http://www.acme.com/logo-small.png
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Attachment.size
    Definition

    The number of bytes of data that make up this attachment (before base64 encoding, if that is done).

    ShortNumber of bytes of content (if url provided)
    Comments

    The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.

    Control0..1
    Typeinteger64
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. Attachment.hash
    Definition

    The calculated hash of the data using SHA-1. Represented using base64.

    ShortHash of the data (sha-1, base64ed)
    Comments

    The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see Provenance.signature for mechanism to protect a resource with a digital signature.

    Control0..1
    Typebase64Binary
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Attachment.title
    Definition

    A format or abbreviation name that identifies a file structure. [Source: SME Defined] Used for the following: Analytical Instrument Data File Type, Impurity Analysis Graphic, Impurity Analytical Instrument Data File, Impurity Chemical Structure Data File, and Substance Structure Graphic.

    ShortDocument file name including the file extension
    Comments

    May sometimes be derived from the source filename.

    Control1..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Requirements

    Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.

    Example<br/><b>General</b>:Official Corporate Logo
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. Attachment.creation
    Definition

    The date that the attachment was first created.

    ShortDate attachment was first created
    Control0..1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    This is often tracked as an integrity issue for use of the attachment.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Attachment.height
    Definition

    Height of the image in pixels (photo/video).

    ShortHeight of the image in pixels (photo/video)
    Control0..1
    TypepositiveInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. Attachment.width
    Definition

    Width of the image in pixels (photo/video).

    ShortWidth of the image in pixels (photo/video)
    Control0..1
    TypepositiveInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. Attachment.frames
    Definition

    The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required.

    ShortNumber of frames if > 1 (photo)
    Comments

    if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.

    Control0..1
    TypepositiveInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. Attachment.duration
    Definition

    The duration of the recording in seconds - for audio and video.

    ShortLength in seconds (audio / video)
    Comments

    The duration might differ from occurrencePeriod if recording was paused.

    Control0..1
    Typedecimal
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Attachment.pages
    Definition

    The number of pages when printed.

    ShortNumber of printed pages
    Control0..1
    TypepositiveInt
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))