odmlib.dataset_1_0_1 module

class odmlib.dataset_1_0_1.model.ItemData(**kwargs)[source]

Bases: ODMElement

A single data value for one item (variable) in a Dataset-XML document.

Each ItemData element holds the actual collected or derived value for one variable in a row of tabular clinical data.

Parameters:: kwargs (Any)

ItemOID

OID reference to the corresponding ItemDef in the associated ODM metadata.

Type:: str, required

Value

The actual data value for this item. May be omitted when the item has no value for this row.

Type:: str

ItemOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

Value: Descriptor for string-valued ODM attributes.

namespace = 'odm'

class odmlib.dataset_1_0_1.model.ItemGroupData(**kwargs)[source]

Bases: ODMElement

One row (record) of data within a Dataset-XML dataset.

Corresponds to a single observation row in a tabular dataset. Contains one ItemData child for every variable in that row that has a value. The data:ItemGroupDataSeq attribute provides the row number for ordering records within the dataset.

Parameters:: kwargs (Any)

ItemGroupOID

OID reference to the ItemGroupDef that describes the dataset structure.

Type:: str, required

ItemGroupDataSeq

Sequential row number for ordering records; stored in the data: namespace.

Type:: int, required

ItemData

Zero or more ItemData children, each carrying one variable value for this row.

Type:: list

ItemGroupOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

ItemGroupDataSeq

Descriptor for positive integer attributes (value > 0).

Combines integer type validation with positive value constraint. Used for Length, ItemGroupDataSeq, and similar attributes.

ItemData

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.dataset_1_0_1.model.ClinicalData(**kwargs)[source]

Bases: ODMElement

A container for subject-level (clinical) tabular data in a Dataset-XML file.

ClinicalData groups all ItemGroupData rows that belong to the same study and metadata version. It is used for SDTM/ADaM datasets containing actual subject observations.

Parameters:: kwargs (Any)

StudyOID

OID reference to the Study in the associated ODM metadata.

Type:: str, required

MetaDataVersionOID

OID reference to the MetaDataVersion that describes the dataset structure.

Type:: str, required

ItemGroupData

Zero or more ItemGroupData rows.

Type:: list

StudyOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

MetaDataVersionOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

ItemGroupData

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.dataset_1_0_1.model.ReferenceData(**kwargs)[source]

Bases: ODMElement

A container for reference (non-subject) tabular data in a Dataset-XML file.

ReferenceData is used for datasets that contain study-level reference information rather than per-subject observations, such as trial design or arm/epoch lookup tables.

Parameters:: kwargs (Any)

StudyOID

OID reference to the Study in the associated ODM metadata.

Type:: str, required

MetaDataVersionOID

OID reference to the MetaDataVersion that describes the dataset structure.

Type:: str, required

ItemGroupData

Zero or more ItemGroupData rows.

Type:: list

StudyOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

MetaDataVersionOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

ItemGroupData

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.dataset_1_0_1.model.ODM(**kwargs)[source]

Bases: ODMElement

The root element of a Dataset-XML 1.0.1 document.

A Dataset-XML file carries tabular clinical or reference data for submission. It references ODM metadata via StudyOID and MetaDataVersionOID and uses namespace http://www.cdisc.org/ns/Dataset-XML/v1.0 (prefix data:) for Dataset-XML-specific attributes such as ItemGroupDataSeq.

Parameters:: kwargs (Any)

Description

Human-readable description of the file.

Type:: str

FileType

“Snapshot” or “Transactional”.

Type:: str, required

FileOID

Globally unique OID for this specific file.

Type:: str, required

CreationDateTime

ISO 8601 datetime when the file was created.

Type:: str, required

PriorFileOID

OID of the preceding file in a sequence.

Type:: str

AsOfDateTime

ISO 8601 datetime indicating currency of the data.

Type:: str

ODMVersion

Version of the base ODM standard being used.

Type:: str

DatasetXMLVersion

Version of the Dataset-XML standard; one of “1.0.0” or “1.0.1”.

Type:: str, required

Originator

Organization that created the file.

Type:: str

SourceSystem

Software system that generated the file.

Type:: str

SourceSystemVersion

Version of the source system.

Type:: str

schemaLocation

xs:schemaLocation attribute for schema validation.

Type:: str

ReferenceData

Zero or more ReferenceData sections.

Type:: list

ClinicalData: A single ClinicalData section.

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.

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.

PriorFileOID

Descriptor for OID reference attributes.

References the OID of a definition element. Used on reference elements (e.g., ItemRef.ItemOID references ItemDef.OID).

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.

DatasetXMLVersion

Descriptor that validates against an explicit list of permitted values.

Unlike ValidValues, the allowed values are provided at class definition time in the valid_values list argument.

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.

ReferenceData

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”).

ClinicalData

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'