odmlib.ct_1_1_1 module

class odmlib.ct_1_1_1.model.TranslatedText(**kwargs)[source]

Bases: ODMElement

A piece of text in a specific language, used inside Description elements.

Parameters:: kwargs (Any)

lang

BCP 47 language tag (xml:lang attribute), e.g. “en”.

Type:: str

_content

The actual text content.

Type:: str, required

lang: Descriptor for string-valued ODM attributes.

namespace = 'odm'

class odmlib.ct_1_1_1.model.Alias(**kwargs)[source]

Bases: ODMElement

An alternative name or identifier for a CT-XML element in an external context.

Parameters:: kwargs (Any)

Context

The context in which the alias applies, e.g. the name of an external system or coding standard.

Type:: str, required

Name

The alias value in that context.

Type:: str, required

Context: Descriptor for string-valued ODM attributes.

Name: Descriptor for string-valued ODM attributes.

namespace = 'odm'

class odmlib.ct_1_1_1.model.StudyDescription(**kwargs)[source]

Bases: ODMElement

A plain-text description of the study in a CT-XML GlobalVariables element.

Parameters:: kwargs (Any)

_content

The study description text.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.ProtocolName(**kwargs)[source]

Bases: ODMElement

The name of the protocol associated with a CT-XML study.

Parameters:: kwargs (Any)

_content

The protocol name string.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.StudyName(**kwargs)[source]

Bases: ODMElement

The short name of the study in a CT-XML GlobalVariables element.

Parameters:: kwargs (Any)

_content

The study name string.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.GlobalVariables(**kwargs)[source]

Bases: ODMElement

Study-level identification variables for a CT-XML document.

Holds the study name, description, and protocol name that identify the controlled terminology package.

Parameters:: kwargs (Any)

StudyName: Short name of the study/package.

StudyDescription: Description of the study/package.

ProtocolName: Name of the associated protocol.

StudyName

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

StudyDescription

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

ProtocolName

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'

class odmlib.ct_1_1_1.model.Description(**kwargs)[source]

Bases: ODMElement

A human-readable description composed of one or more language-tagged text blocks.

Parameters:: kwargs (Any)

TranslatedText

One or more TranslatedText children providing the description in different languages.

Type:: list, required

TranslatedText

Descriptor for a list of child ODM elements.

Validates that all items assigned to the list are instances of the expected element class. Stored as a plain list in the instance.

Parameters:

element_class (type) – The class that all list items must be.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'

class odmlib.ct_1_1_1.model.CDISCSynonym(**kwargs)[source]

Bases: ODMElement

A CDISC synonym for a controlled terminology term.

Multiple CDISCSynonym elements may appear within a single EnumeratedItem or CodeList to list all recognized synonyms.

Parameters:: kwargs (Any)

_content

The synonym text string.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.CDISCDefinition(**kwargs)[source]

Bases: ODMElement

The CDISC-authored definition of a controlled terminology term.

Parameters:: kwargs (Any)

_content

The full definition text for the term as published by CDISC.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.CDISCSubmissionValue(**kwargs)[source]

Bases: ODMElement

The CDISC submission value (the value to use in regulatory submissions) for a CodeList.

Appears as a child of CodeList to provide the canonical submission value for the entire controlled terminology concept.

Parameters:: kwargs (Any)

_content

The submission value string.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.PreferredTerm(**kwargs)[source]

Bases: ODMElement

The NCI preferred term for a controlled terminology concept.

The preferred term is the primary human-readable label used by NCI/EVS for this concept.

Parameters:: kwargs (Any)

_content

The NCI preferred term string.

Type:: str, required

namespace = 'odm'

class odmlib.ct_1_1_1.model.EnumeratedItem(**kwargs)[source]

Bases: ODMElement

A single coded term (enumerated value) in a CT-XML CodeList.

Represents one controlled terminology concept with its NCI code, CDISC synonyms, definition, and NCI preferred term. Uses the nciodm: namespace for NCI-specific attributes and child elements.

Parameters:: kwargs (Any)

CodedValue

The submission value for this term (the value written into datasets).

Type:: str, required

ExtCodeID

NCI concept code for this term (nciodm:ExtCodeID attribute).

Type:: str, required

CDISCSynonym

Zero or more CDISC synonyms (nciodm:CDISCSynonym elements).

Type:: list

CDISCDefinition

CDISC definition of this term (nciodm:CDISCDefinition element).

Type:: required

PreferredTerm

NCI preferred term (nciodm:PreferredTerm element).

Type:: required

CodedValue: Descriptor for string-valued ODM attributes.

ExtCodeID: Descriptor for string-valued ODM attributes.

CDISCSynonym

Descriptor for a list of child ODM elements.

Validates that all items assigned to the list are instances of the expected element class. Stored as a plain list in the instance.

Parameters:

element_class (type) – The class that all list items must be.
namespace (str) – XML namespace prefix (default: “odm”).

CDISCDefinition

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

PreferredTerm

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'

class odmlib.ct_1_1_1.model.CodeList(**kwargs)[source]

Bases: ODMElement

A CDISC controlled terminology code list in a CT-XML 1.1.1 document.

Represents a single controlled terminology concept (e.g. the RACE code list) with all its coded values. NCI-specific metadata (ExtCodeID, CodeListExtensible, CDISCSubmissionValue, CDISCSynonym, PreferredTerm) uses the nciodm: namespace.

Parameters:: kwargs (Any)

OID

Unique identifier for this code list.

Type:: str, required

Name

Human-readable name of the code list.

Type:: str, required

DataType

Data type of the coded values (e.g. “text”).

Type:: str, required

ExtCodeID

NCI concept code for the code list itself (nciodm:ExtCodeID attribute).

Type:: str, required

CodeListExtensible

Whether sponsors may add additional terms (“Yes” or “No”) (nciodm:CodeListExtensible attribute).

Type:: str, required

Description: Optional human-readable description.

EnumeratedItem

The coded terms that belong to this code list.

Type:: list

CDISCSubmissionValue

The canonical submission value for the overall code list concept (nciodm:CDISCSubmissionValue).

Type:: required

CDISCSynonym

A CDISC synonym for the code list concept (nciodm:CDISCSynonym).

Type:: required

PreferredTerm

NCI preferred term for the code list concept (nciodm:PreferredTerm).

Type:: required

OID

Descriptor for OID (Object Identifier) attributes.

OIDs uniquely identify definition elements within a MetaDataVersion. Used on the OID attribute of *Def elements (e.g., ItemDef.OID).

Name: Descriptor for the Name attribute of ODM elements.

DataType

String descriptor that validates against a dynamically-loaded set of permitted values.

Combines string type validation with value set membership checking. Used for attributes like FileType, Repeating, Mandatory, DataType, etc.

ExtCodeID: Descriptor for string-valued ODM attributes.

CodeListExtensible

String descriptor that validates against a dynamically-loaded set of permitted values.

Combines string type validation with value set membership checking. Used for attributes like FileType, Repeating, Mandatory, DataType, etc.

Description

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

EnumeratedItem

Descriptor for a list of child ODM elements.

Validates that all items assigned to the list are instances of the expected element class. Stored as a plain list in the instance.

Parameters:

element_class (type) – The class that all list items must be.
namespace (str) – XML namespace prefix (default: “odm”).

CDISCSubmissionValue

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

CDISCSynonym

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

PreferredTerm

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'

class odmlib.ct_1_1_1.model.MetaDataVersion(**kwargs)[source]

Bases: ODMElement

A versioned container for all controlled terminology code lists in a CT-XML document.

Parameters:: kwargs (Any)

OID

Unique identifier for this metadata version.

Type:: str, required

Name

Human-readable name.

Type:: str, required

Description

Optional plain-text description of this version.

Type:: str

CodeList

Zero or more CodeList elements defining the controlled terminology for this version.

Type:: list

OID

Descriptor for OID (Object Identifier) attributes.

OIDs uniquely identify definition elements within a MetaDataVersion. Used on the OID attribute of *Def elements (e.g., ItemDef.OID).

Name: Descriptor for the Name attribute of ODM elements.

Description: Descriptor for string-valued ODM attributes.

CodeList

Descriptor for a list of child ODM elements.

Validates that all items assigned to the list are instances of the expected element class. Stored as a plain list in the instance.

Parameters:

element_class (type) – The class that all list items must be.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'

class odmlib.ct_1_1_1.model.Study(**kwargs)[source]

Bases: ODMElement

The study element in a CT-XML 1.1.1 document.

Identifies the controlled terminology package and contains the GlobalVariables and one or more MetaDataVersion elements with the code lists.

Parameters:: kwargs (Any)

OID

Unique identifier for the study/package.

Type:: str, required

GlobalVariables

Study identification variables (name, description, protocol name).

Type:: required

MetaDataVersion

Zero or more versioned containers of controlled terminology code lists.

Type:: list

OID: Descriptor for string-valued ODM attributes.

GlobalVariables

Descriptor for a single child ODM element.

Stores a reference to the element class and validates type on assignment. When accessed on an unset optional attribute, instantiates the element class with no arguments.

Parameters:

element_class (type) – The expected child element class.
namespace (str) – XML namespace prefix (default: “odm”).

MetaDataVersion

Descriptor for a list of child ODM elements.

Validates that all items assigned to the list are instances of the expected element class. Stored as a plain list in the instance.

Parameters:

element_class (type) – The class that all list items must be.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'

class odmlib.ct_1_1_1.model.ODM(**kwargs)[source]

Bases: ODMElement

The root element of a CT-XML 1.1.1 controlled terminology document.

A CT-XML file distributes CDISC/NCI controlled terminology packages. It uses the base ODM namespace (http://www.cdisc.org/ns/odm/v1.3) and the NCI extension namespace (http://ncicb.nci.nih.gov/xml/odm/EVS/CDISC, prefix nciodm:).

Parameters:: kwargs (Any)

Description

Human-readable description of the file.

Type:: str

FileType

“Snapshot” or “Transactional”.

Type:: str, required

Granularity

Level of data included.

Type:: str

FileOID

Globally unique OID for this file.

Type:: str, required

CreationDateTime

ISO 8601 datetime of file creation.

Type:: str, required

AsOfDateTime

ISO 8601 datetime indicating currency of the terminology.

Type:: str

ODMVersion

Version of the ODM standard.

Type:: str

Originator

Organization that produced the file.

Type:: str

SourceSystem

Software system that generated the file.

Type:: str

SourceSystemVersion

Version of the source system.

Type:: str

schemaLocation

xs:schemaLocation for schema validation.

Type:: str

Study

One or more Study elements containing code lists.

Type:: list

Description: Descriptor for string-valued ODM attributes.

FileType

String descriptor that validates against a dynamically-loaded set of permitted values.

Combines string type validation with value set membership checking. Used for attributes like FileType, Repeating, Mandatory, DataType, etc.

Granularity

String descriptor that validates against a dynamically-loaded set of permitted values.

Combines string type validation with value set membership checking. Used for attributes like FileType, Repeating, Mandatory, DataType, etc.

FileOID

Descriptor for OID (Object Identifier) attributes.

OIDs uniquely identify definition elements within a MetaDataVersion. Used on the OID attribute of *Def elements (e.g., ItemDef.OID).

CreationDateTime

Descriptor for ISO 8601 datetime strings.

Validates format: YYYY-MM-DDTHH:MM:SS[.sss][Z|±HH:MM]

Used for CreationDateTime, AsOfDateTime, and similar attributes.

AsOfDateTime

Descriptor for ISO 8601 datetime strings.

Validates format: YYYY-MM-DDTHH:MM:SS[.sss][Z|±HH:MM]

Used for CreationDateTime, AsOfDateTime, and similar attributes.

ODMVersion

String descriptor that validates against a dynamically-loaded set of permitted values.

Combines string type validation with value set membership checking. Used for attributes like FileType, Repeating, Mandatory, DataType, etc.

Originator: Descriptor for string-valued ODM attributes.

SourceSystem: Descriptor for string-valued ODM attributes.

SourceSystemVersion: Descriptor for string-valued ODM attributes.

schemaLocation: Descriptor for string-valued ODM attributes.

Study

Descriptor for a list of child ODM elements.

Validates that all items assigned to the list are instances of the expected element class. Stored as a plain list in the instance.

Parameters:

element_class (type) – The class that all list items must be.
namespace (str) – XML namespace prefix (default: “odm”).

namespace = 'odm'