Class Reference for Builders

Builders provide a way to construct an ODM XML document from Python object.

Note

Any Class with the Prefix Mdsol represents a Medidata Rave specific extension

Metadata Builders

Metadata Builders provide an API for creating ODM metadata elements

class rwslib.builders.metadata.Alias(context, name)
An Alias provides an additional name for an element.

The Context attribute specifies the application domain in which this additional name is relevant.

Parameters:

  • context (str) – Context attribute specifies the application domain

  • name (str) – Name

class rwslib.builders.metadata.BasicDefinitions

Container for MeasurementUnit

measurement_units

Collection of MeasurementUnit

class rwslib.builders.metadata.CheckValue(value)

A value in a RangeCheck

Parameters:

value (str) – Value for a RangeCheck

class rwslib.builders.metadata.CodeList(oid, name, datatype, sas_format_name=None)

Defines a discrete set of permitted values for an item.

Note

  • Equates to a Rave Dictionary

  • Does not support ExternalCodeList

Parameters:

  • oid (str) – CodeList OID

  • name (str) – Name of CodeList

  • datatype (DataType) – DataType restricts the values that can appear in the CodeList whether internal or external (integer | float | text | string )

  • sas_format_name (str) – SASFormatName must be a legal SAS format for CodeList

aliases

Collection of Alias

codelist_items

Collection of CodeListItem

class rwslib.builders.metadata.CodeListItem(coded_value, order_number=None, specify=False)

Defines an individual member value of a CodeList including display format. The actual value is given, along with a set of print/display-forms.

Parameters:

  • coded_value (str) – Coded Value for CodeListItem

  • order_number (int) – OrderNumber for the CodeListItem - Note: this is a Medidata Rave Extension, but upstream ODM has been updated to include the OrderNumber attribute

  • specify (bool) – Does this have a Specify? option? - Rave Specific Attribute

aliases

Collection of Alias

class rwslib.builders.metadata.CodeListRef(oid)

A reference to a CodeList definition.

Parameters:

oid – OID for CodeList

class rwslib.builders.metadata.Decode

The displayed value relating to the CodedValue

translations

Collection of Translation for the Decode

class rwslib.builders.metadata.FormDef(oid, name, repeating=False, order_number=None, active=True, template=False, signature_required=False, log_direction='Portrait', double_data_entry='MustNotDDE', confirmation_style='NoLink', link_study_event_oid=None, link_form_oid=None)

A FormDef describes a type of form that can occur in a study.

Parameters:

  • oid (str) – OID for FormDef

  • name (str) – Name for FormDef

  • repeating (bool) – Is this a repeating Form?

  • order_number (int) – OrderNumber for the FormDef

  • active (bool) – Indicates that the form is available to end users when you publish and push the draft to Rave EDC - Rave Specific Attribute

  • template (bool) – Indicates that the form is a template form in Rave EDC - Rave Specific Attribute

  • signature_required (bool) – Select to ensure that the form requires investigator signature for all submitted data points - Rave Specific Attribute

  • log_direction (str) – Set the display mode of a form, (Landscape or Portrait) - Rave Specific Attribute

  • double_data_entry (str) – Indicates if the form is used to collect data in Rave Double Data Entry (DDE), (Always, Never or As Per Site) - Rave Specific Attribute

  • confirmation_style – Style of Confirmation, (None, NotLink, LinkNext or LinkCustom) - Rave Specific Attribute

  • link_study_event_oid – OID for StudyEvent target for Link - Rave Specific Attribute

  • link_form_oid – OID for FormRef target for Link - Rave Specific Attribute

aliases

Collection of Alias for Form

entry_restrictions

Collection of EntryRestriction for Form - Rave Specific Attribute

helptexts

Collection of HelpText for Form (Cardinality not clear) - Rave Specific Attribute

itemgroup_refs

Collection of ItemGroupRef for Form

view_restrictions

Collection of ViewRestriction for Form - Rave Specific Attribute

class rwslib.builders.metadata.FormRef(oid, order_number, mandatory)

A reference to a FormDef as it occurs within a specific StudyEventDef . The list of FormRef identifies the types of forms that are allowed to occur within this type of study event. The FormRef within a single StudyEventDef must not have duplicate FormOIDs nor OrderNumbers.

Parameters:

  • oid (str) – Set the FormDef OID for the FormRef

  • order_number (int) – Define the OrderNumber for the FormRef within the containing StudyEventDef

  • mandatory (bool) – Is this Form Mandatory?

class rwslib.builders.metadata.GlobalVariables(protocol_name, name=None, description='')

GlobalVariables includes general summary information about the Study.

Note

Name and description are not important. protocol_name maps to the Rave project name

Parameters:

  • protocol_name (str) – Protocol Name

  • name (str) – Study Name

  • description (str) – Study Description

class rwslib.builders.metadata.ItemDef(oid, name, datatype, length=None, significant_digits=None, sas_field_name=None, sds_var_name=None, origin=None, comment=None, active=True, control_type=None, acceptable_file_extensions=None, indent_level=0, source_document_verify=False, default_value=None, sas_format=None, sas_label=None, query_future_date=False, visible=True, translation_required=False, query_non_conformance=False, other_visits=False, can_set_item_group_date=False, can_set_form_date=False, can_set_study_event_date=False, can_set_subject_date=False, visual_verify=False, does_not_break_signature=False, date_time_format=None, field_number=None, variable_oid=None)

An ItemDef describes a type of item that can occur within a study. Item properties include name, datatype, measurement units, range or codelist restrictions, and several other properties.

Parameters:

  • oid (str) – OID for ItemDef

  • name (str) – Name for ItemDef

  • datatype (DataType) – Datatype for ItemDef

  • length (int) – Max. Length of content expected in Item Value

  • significant_digits (int) – Max. Number of significant digits in Item Value

  • sas_field_name (str) – SAS Name for the ItemDef

  • sds_var_name (str) – SDS Variable Name

  • origin (str) – Origin for the Variable

  • comment (str) – Comment for the Variable

  • active (bool) – Is the Variable Active? - Rave Specific Attribute

  • control_type (ControlType) – Control Type for the Variable - Rave Specific Attribute

  • acceptable_file_extensions (str) – File extensions for File Upload Control (separated by a comma) - Rave Specific Attribute

  • indent_level (int) – Level of indentation of a field from the left-hand page margin. - Rave Specific Attribute

  • source_document_verify (bool) – Does this Variable need to be SDV’ed? - Rave Specific Attribute

  • default_value (str) – Value entered in this field is displayed as the default value in Rave EDC. - Rave Specific Attribute

  • sas_format (str) – SAS variable format of maximum 25 alphanumeric characters.

  • sas_label (str) – SAS label of maximum 256 alphanumeric characters.

  • query_future_date (bool) – Generates a query when the Rave EDC user enters a future date in the field. - Rave Specific Attribute

  • visible (bool) – Indicates that the field displays on the form when the version is pushed to Rave EDC. - Rave Specific Attribute

  • translation_required (bool) – Enables translation functionality for the selected field. - Rave Specific Attribute

  • query_non_conformance (bool) – Generates a query when the Rave EDC user enters data in a format other than what has been defined for the variable. - Rave Specific Attribute

  • other_visits (bool) – Display previous visit data - Rave Specific Attribute

  • can_set_item_group_date (bool) – If a form contains log fields, this parameter assigns the date entered into the field as the date for the record (log line) - Rave Specific Attribute

  • can_set_form_date (bool) – Observation Date of Form assigns the date entered into the field as the date for the form - Rave Specific Attribute

  • can_set_study_event_date (bool) – Observation Date of Folder assigns the date entered into the field as the date for the folder - Rave Specific Attribute

  • can_set_subject_date (bool) – Observation Date of Subject assigns the date entered into the field as the date for the Subject. - Rave Specific Attribute

  • visual_verify (bool) – This parameter sets the field as a Visual Verify field in Rave DDE - Rave Specific Attribute

  • does_not_break_signature (bool) – Indicates that the field (both derived and non-derived) does not participate in signature. - Rave Specific Attribute

  • date_time_format (str) – Displays text boxes for the user to enter the day, month, and year according to the specified variable format. - Rave Specific Attribute

  • field_number (str) – Number that displays to the right of a field label in Rave EDC to create a numbered list on the form. - Rave Specific Attribute

  • variable_oid – OID for Variable - Rave Specific Attribute

aliases

Collection of Alias

codelistref

Matching CodeListRef

entry_restrictions

Collection of MdsolEntryRestriction

header_text

Matching MdsolHeaderText

help_texts

Collection of MdsolHelpText

measurement_unit_refs

Collection of MeasurementUnitRef

question

Matching Question

range_checks

Collection of RangeCheck

review_groups

Collection of MdsolReviewGroup

view_restrictions

Collection of MdsolViewRestriction

class rwslib.builders.metadata.ItemGroupDef(oid, name, repeating=False, is_reference_data=False, sas_dataset_name=None, domain=None, origin=None, role=None, purpose=None, comment=None)

An ItemGroupDef describes a type of item group that can occur within a Study.

Parameters:

  • oid (str) – OID for ItemGroupDef

  • name (str) – Name for ItemGroupDef

  • repeating (bool) – Is this a repeating ItemDef?

  • is_reference_data (bool) – If IsReferenceData is Yes, this type of item group can occur only within a ReferenceData element. If IsReferenceData is No, this type of item group can occur only within a ClinicalData element. The default for this attribute is No.

  • sas_dataset_name (str) – SAS Dataset Name

  • domain (str) – Domain for Items within this ItemGroup

  • origin – Origin of data (eg CRF, eDT, Derived)

  • role – Role for the ItemGroup (eg Identifier, Topic, Timing, Qualifiers)

  • purpose – Purpose (eg Tabulation)

  • comment – Comment on the ItemGroup Contents

aliases

Collection of Alias

item_refs

Collection of ItemRef

label_refs

Collection of MdsolLabelRef

class rwslib.builders.metadata.ItemGroupRef(oid, order_number=None, mandatory=True)

A reference to an ItemGroupDef as it occurs within a specific FormDef. The list of ItemGroupRefs identifies the types of item groups that are allowed to occur within this type of form. The ItemGroupRefs within a single FormDef must not have duplicate ItemGroupOIDs nor OrderNumbers.

Parameters:

  • oid (str) – OID for the referenced ItemGroupDef

  • order_number (int) – OrderNumber for the ItemGroupRef

  • mandatory (bool) – Is this ItemGroupRef required?

class rwslib.builders.metadata.ItemRef(oid, order_number=None, mandatory=False, key_sequence=None, imputation_method_oid=None, role=None, role_codelist_oid=None)

A reference to an ItemDef as it occurs within a specific ItemGroupDef. The list of ItemRefs identifies the types of items that are allowed to occur within this type of item group.

Parameters:

  • oid (str) – OID for ItemDef

  • order_number (int) – OrderNumber for the ItemRef

  • mandatory (bool) – Is this ItemRef required?

  • key_sequence (int) – The KeySequence (if present) indicates that this item is a key for the enclosing item group. It also provides an ordering for the keys.

  • imputation_method_oid (str) – DEPRECATED

  • role (str) – Role name describing the use of this data item.

  • role_codelist_oid (str) – RoleCodeListOID may be used to reference a CodeList that defines the full set roles from which the Role attribute value is to be taken.

attributes

Collection of MdsolAttribute

class rwslib.builders.metadata.MdsolAttribute(namespace, name, value, transaction_type='Insert')

Rave Web Services element for holding Vendor Attributes

Note

This is Medidata Rave Specific Element

name

Name for the Attribute

namespace

Namespace for the Attribute

transaction_type

TransactionType for the Attribute

value

Value for the Attribute

class rwslib.builders.metadata.MdsolCheckAction(variable_oid=None, field_oid=None, form_oid=None, folder_oid=None, record_position=None, form_repeat_number=None, folder_repeat_number=None, check_action_type=None, check_string=None, check_options=None, check_script=None)

Check Action modeled after check action in Architect Loader spreadsheet.

Note

  • Do not use directly, use appropriate sub-class.

  • This is a Medidata Rave Specific Element

Parameters:

  • variable_oid (str) – OID for the Variable that is the target of the CheckAction

  • field_oid (str) – OID for the Field that is the target of the CheckAction

  • form_oid (str) – OID for the Form that is the target of the CheckAction

  • folder_oid (str) – OID for the Folder that is the target of the CheckAction

  • record_position (int) – Record Position for the CheckAction

  • form_repeat_number (int) – Form Repeat Number for the CheckAction

  • folder_repeat_number (int) – Folder Repeat Number for the CheckAction

  • check_string (str) – CheckAction String

  • check_options (str) – CheckAction Options

  • check_script (str) – CheckAction Script

property check_action_type

return the CheckAction Type

class rwslib.builders.metadata.MdsolCheckStep(variable_oid=None, data_format=None, form_oid=None, folder_oid=None, field_oid=None, static_value=None, function=None, custom_function=None, record_position=None, form_repeat_number=None, folder_repeat_number=None, logical_record_position=None)

A check step modeled after the Architect Loader definition.

Note

Do not use directly, use appropriate subclasses.

Note

this is a Medidata Rave Specific Element

Parameters:

  • variable_oid (str) – OID for Variable targeted by CheckStep

  • data_format (str) – Format for Value

  • form_oid (str) – OID for Form

  • folder_oid (str) – OID for Folder

  • field_oid (str) – OID for Field

  • custom_function (str) – Name of Custom Function for CheckStep

  • record_position (int) – Record Position - If the field is a standard (non-log) field, enter 0

  • form_repeat_number (int) – Repeat Number for Form for CheckStep

  • folder_repeat_number (int) – Repeat Number for Folder for CheckStep

  • logical_record_position (LogicalRecordPositionType) – LRP value for the CheckStep

  • static_value (str) – Static Value for CheckStep

  • function (StepType) – Check Function for CheckStep

property logical_record_position

Get the Logical Record Position :return: the Logical Record Position

class rwslib.builders.metadata.MdsolConfirmationMessage(message, lang=None)

Form is saved confirmation message

Note

this is a Medidata Rave Specific Element

Parameters:

  • message (str) – Content of confirmation message

  • lang (str) – Language declaration for Message

class rwslib.builders.metadata.MdsolCustomFunctionDef(oid, code, language='C#')

Extension for Rave Custom functions

Note

  • This is a Medidata Rave Specific Extension

  • VB has been deprecated in later Rave versions.

Parameters:

  • oid (str) – OID for CustomFunction

  • code (str) – Content for the CustomFunction

  • language (str) – Language for the CustomFunction

class rwslib.builders.metadata.MdsolDerivationDef(oid, active=True, bypass_during_migration=False, needs_retesting=False, variable_oid=None, field_oid=None, form_oid=None, folder_oid=None, record_position=None, form_repeat_number=None, folder_repeat_number=None, logical_record_position=None, all_variables_in_folders=None, all_variables_in_fields=None)

Extension for Rave derivations

Note

This is a Medidata Rave Specific Extension

Parameters:

  • oid (str) – OID for Derivation

  • active (bool) – Is this Derivation Active?

  • bypass_during_migration (bool) – Bypass this Derivation on Study Migration?

  • needs_retesting (bool) – Does this Derivation need retesting?

  • variable_oid (str) – OID for target variable (eg OID for ItemDef)

  • field_oid (str) – OID for target field (eg OID for ItemDef)

  • form_oid (str) – OID for Form for target of Derivation (eg OID for FormDef)

  • folder_oid (str) – OID for Folder for target of Derivation (eg OID for StudyEventDef)

  • record_position (int) – Record Position for the Derivation

  • form_repeat_number (int) – Form Repeat Number for the CheckAction

  • folder_repeat_number (int) – Folder Repeat Number for the CheckAction

  • logical_record_position (LogicalRecordPositionType)

  • all_variables_in_folders (bool) – Evaluates the derivation according to any field using the specified variable within a specific folder.

  • all_variables_in_fields (bool) – Evaluates the derivation according to any field using the specified variable across the whole subject.

derivation_steps

Set of MdsolDerivationStep for this derivation

property logical_record_position

Get the Logical Record Position :return: the Logical Record Position

class rwslib.builders.metadata.MdsolDerivationStep(variable_oid=None, data_format=None, form_oid=None, folder_oid=None, field_oid=None, value=None, function=None, custom_function=None, record_position=None, form_repeat_number=None, folder_repeat_number=None, logical_record_position=None)

A derivation step modeled after the Architect Loader definition.

Note

Do not use directly, use appropriate subclasses.

Note

this is a Medidata Rave Specific Element

Parameters:

  • variable_oid (str) – OID for Variable targeted by Derivation

  • data_format (str) – Format for Value

  • form_oid (str) – OID for Form

  • folder_oid (str) – OID for Folder

  • field_oid (str) – OID for Field

  • value (str) – Value for DerivationStep

  • custom_function (str) – Name of Custom Function for DerivationStep

  • record_position (int) – Record Position - If the field is a standard (non-log) field, enter 0

  • form_repeat_number (int) – Repeat Number for Form for DerivationStep

  • folder_repeat_number (int) – Repeat Number for Folder for DerivationStep

  • logical_record_position (LogicalRecordPositionType) – LRP value for the DerivationStep

property function

Return the Derivation Function :return:

property logical_record_position

Get the Logical Record Position :return: the Logical Record Position

class rwslib.builders.metadata.MdsolEditCheckDef(oid, active=True, bypass_during_migration=False, needs_retesting=False)

Extension for Rave edit checks

Note

This is a Medidata Rave Specific Extension

Parameters:

  • oid (str) – EditCheck OID

  • active (bool) – Is this EditCheck active?

  • bypass_during_migration (bool) – Bypass this EditCheck during a Study Migration

  • needs_retesting (bool) – Does this EditCheck need Retesting?

check_actions

Set of MdsolCheckAction for this EditCheck

check_steps

Set of MdsolCheckStep for this EditCheck

class rwslib.builders.metadata.MdsolEntryRestriction(rolename)

EntryRestriction for FormDef and ItemDef

Note

This is Medidata Rave Specific Element

rolename

Name for the role for which the EntryRestriction applies

class rwslib.builders.metadata.MdsolHeaderText(content, lang=None)

Header text for ItemDef when shown in grid

Note

this is a Medidata Rave Specific Element

Parameters:

  • content (str) – Content for the Header Text

  • lang (str) – Language specification for Header

class rwslib.builders.metadata.MdsolHelpText(lang, content)

Help element for FormDef and ItemDef

Note

This is Medidata Rave Specific Element

content

HelpText content

lang

Language specification for HelpText

class rwslib.builders.metadata.MdsolLabelDef(oid, name, field_number=None)

Label definition

Note

This is a Medidata Rave Specific Element

Parameters:

  • oid – OID for the MdsolLabelDef

  • name – Name for the MdsolLabelDef

  • field_number (int) – FieldNumber for the MdsolLabelDef

help_texts

Collection of HelpText

translations

Collection of Translation

view_restrictions

Collection of ViewRestriction

class rwslib.builders.metadata.MdsolLabelRef(oid, order_number)

A reference to a label on a form

Note

This is Medidata Rave Specific Element

oid

OID for the corresponding MdsoLabel

order_number

OrderNumber for the Label

class rwslib.builders.metadata.MdsolReviewGroup(name)

Maps to Rave review groups for an ItemDef

Note

this is a Medidata Rave Specific Element

Parameters:

name (str) – Name for the MdsolReviewGroup

class rwslib.builders.metadata.MdsolViewRestriction(rolename)

ViewRestriction for FormDef and ItemDef

Note

This is Medidata Rave Specific Element

rolename

Name for the role for which the ViewRestriction applies

class rwslib.builders.metadata.MeasurementUnit(oid, name, unit_dictionary_name=None, constant_a=1, constant_b=1, constant_c=0, constant_k=0, standard_unit=False)

The physical unit of measure for a data item or value. The meaning of a MeasurementUnit is determined by its Name attribute.

Parameters:

  • oid (str) – MeasurementUnit OID

  • name (str) – Maps to Coded Unit within unit dictionary entries in Rave.

  • unit_dictionary_name (str) – Maps to unit dictionary Name in Rave. - Rave specific attribute

  • constant_a (int) – Maps to the unit dictionary Constant A in Rave. - Rave specific attribute

  • constant_b (int) – Maps to the unit dictionary Constant B in Rave. - Rave specific attribute

  • constant_c (int) – Maps to the unit dictionary Constant C in Rave. - Rave specific attribute

  • constant_k (int) – Maps to the unit dictionary Constant K in Rave. - Rave specific attribute

  • standard_unit (bool) – Yes = Standard checked within the unit dictionary entry in Rave. No = Standard unchecked within the unit dictionary entry in Rave. - Rave specific attribute

symbols

Collection of Symbol for this MeasurementUnit

class rwslib.builders.metadata.MeasurementUnitRef(oid)

A reference to a measurement unit definition (MeasurementUnit).

Parameters:

oid (str) – MeasurementUnit OID

class rwslib.builders.metadata.MetaDataVersion(oid, name, description=None, primary_formoid=None, default_matrix_oid=None, delete_existing=False, signature_prompt=None)

A metadata version (MDV) defines the types of study events, forms, item groups, and items that form the study data.

Parameters:

  • oid (str) – MDV OID

  • name (str) – Name for MDV

  • description (str) – Description for MDV

  • primary_formoid (str) – OID of Primary Form - Rave Specific Attribute

  • default_matrix_oid (str) – OID of Default Matrix - Rave Specific Attribute

  • delete_existing (bool) – Overwrite the previous version - Rave Specific Attribute

  • signature_prompt (str) – Prompt for Signature - Rave Specific Attribute

class rwslib.builders.metadata.Protocol

The Protocol lists the kinds of study events that can occur within a specific version of a Study. All clinical data must occur within one of these study events.

study_event_refs

Collection of StudyEventRef

class rwslib.builders.metadata.Question

A label shown to a human user when prompted to provide data for an item on paper or on a screen.

translations

Collection of Translation for the Question

class rwslib.builders.metadata.RangeCheck(comparator, soft_hard)

Rangecheck in Rave relates to QueryHigh QueryLow and NonConformantHigh and NonComformantLow for other types of RangeCheck, need to use an EditCheck (part of Rave’s extensions to ODM)

Parameters:

  • comparator (str) – Comparator for RangeCheck (LT, LE, GT, GE, EQ, NE, IN, NOTIN)

  • soft_hard (str) – Soft or Hard range check (Soft, Hard)

property comparator

returns the comparator

property soft_hard

returns the Soft or Hard range setting

class rwslib.builders.metadata.Study(oid, project_type=None)

This element collects static structural information about an individual study.

Parameters:

  • oid (str) – Study OID

  • project_type (str) – Type of Project (Project or Global Library) - Rave Specific Attribute

studyevent_defs

set of StudyEventDef for this Study element

class rwslib.builders.metadata.StudyEventDef(oid, name, repeating, event_type, category=None, access_days=None, start_win_days=None, target_days=None, end_win_days=None, overdue_days=None, close_days=None)

A StudyEventDef packages a set of forms. Scheduled Study Events correspond to sets of forms that are expected to be collected for each subject as part of the planned visit sequence for the study. Unscheduled Study Events are designed to collect data that may or may not occur for any particular subject such as a set of forms that are completed for an early termination due to a serious adverse event.

Parameters:

  • oid (str) – OID for StudyEventDef

  • name (str) – Name for StudyEventDef

  • repeating (bool) – Is this a repeating StudyEvent?

  • event_type (str) – Type of StudyEvent (either Scheduled, Unscheduled, Common)

  • category (str) – Category attribute is typically used to indicate the study phase appropriate to this type of study event. Examples might include Screening, PreTreatment, Treatment, and FollowUp.

  • access_days (int) – The number of days before the Target date that the folder may be opened, viewed and edited from the Task List in Rave EDC. - Rave Specific Attribute

  • start_win_days (int) – The number of days before the Target date that is considered to be the ideal start-date for use of this folder. - Rave Specific Attribute

  • target_days (int) – The ideal number of days between Time Zero and the date of use for the folder. - Rave Specific Attribute

  • end_win_days (int) – The number of days after the Target date that is considered to be the ideal end date for use of this folder. - Rave Specific Attribute

  • overdue_days (int) – The number of days after the Target date at which point empty data points are marked overdue, and are displayed in the Task Summary in Rave EDC. - Rave Specific Attribute

  • close_days (int) – The number of days after the Target date at which point no new data may be entered into the folder. - Rave Specific Attribute

class rwslib.builders.metadata.StudyEventRef(oid, order_number=None, mandatory=False)

A reference to a StudyEventDef as it occurs within a specific version of a Study. The list of StudyEventRef identifies the types of study events that are allowed to occur within the study. The StudyEventRef within a Protocol must not have duplicate StudyEventOIDs nor duplicate OrderNumbers.

Note

In Rave the OrderNumber attribute is not reported for the SUBJECT Form, for this reason the order_number attribute is not mandatory and will default to None

Parameters:

  • oid (str) – StudyEventDef OID

  • order_number (Union(int, None)) – OrderNumber for the StudyEventRef within the Study

  • mandatory (bool) – Is this StudyEventDef Mandatory? (True|False)

class rwslib.builders.metadata.Symbol

A human-readable name for a MeasurementUnit.

translations

Collection of TranslatedText

class rwslib.builders.metadata.TranslatedText(text, lang=None)

Represents a language and a translated text for that language

Parameters:

  • text (str) – Content expressed in language designated by lang

  • lang (str) – Language code

Clinical Data Builders

Clinical Data Builders provide an API for creating ODM data elements

class rwslib.builders.clinicaldata.Annotation(annotation_id=None, seqnum=1, flags=None, comment=None, transaction_type=None)

A general note about clinical data. If an annotation has both a comment and flags, the flags should be related to the comment.

Note

Annotation is not supported by Medidata Rave

Parameters:

  • id (str or None) – ID for this Annotation (required if contained within an Annotations element)

  • seqnum (int) – SeqNum for Annotation

  • flags (Flag or list(Flag)) – one or more Flag for the Annotation

  • comment (Comment) – one or more Comment for the Annotation

  • transaction_type – TransactionType for Annotation (one of Insert, Update, Remove, Upsert, Context)

property annotation_id

ID for annotation

Note

If an Annotation is contained with an Annotations element, the ID attribute is required.

property seqnum

SeqNum attribute (a small positive integer) uniquely identifies the annotation within its parent entity.

class rwslib.builders.clinicaldata.Annotations(annotations=[])

Groups Annotation elements referenced by ItemData[TYPE] elements.

class rwslib.builders.clinicaldata.AuditRecord(edit_point=None, used_imputation_method=None, identifier=None, include_file_oid=None)

An AuditRecord carries information pertaining to the creation, deletion, or modification of clinical data. This information includes who performed that action, and where, when, and why that action was performed.

Note

AuditRecord is supported only by ItemData in Rave

Parameters:

  • identifier (str) – Audit identifier

  • edit_point (str) – EditPoint attribute identifies the phase of data processing in which action occurred (Monitoring, DataManagement, DBAudit)

  • used_imputation_method (bool) – Indicates whether the action involved the use of a Method

  • include_file_oid (bool) – Include the FileOID in the AuditRecord

property audit_id

AuditRecord ID

Note

If an AuditRecord is contained within an AuditRecords element, the ID attribute must be provided.

date_time_stamp

DateTimeStamp for the AuditRecord

property edit_point
EditPoint attribute identifies the phase of data processing in which action occurred

(Monitoring, DataManagement, DBAudit)

location_ref

LocationRef for the AuditRecord

reason_for_change

ReasonForChange for the AuditRecord

source_id

SourceID for the AuditRecord

user_ref

UserRef for the AuditRecord

class rwslib.builders.clinicaldata.ClinicalData(projectname, environment, metadata_version_oid='1', annotations=None)

Models the ODM ClinicalData object

Parameters:

  • projectname – Name of Project in Medidata Rave

  • environment – Rave Study Enviroment

  • metadata_version_oid – MetadataVersion OID

subject_data

collection of SubjectData for the ClinicalData Element

class rwslib.builders.clinicaldata.Comment(text=None, sponsor_or_site=None)

A free-text (uninterpreted) comment about clinical data. The comment may have come from the Sponsor or the clinical Site.

Note

Comment is not supported by Medidata Rave

Parameters:

  • text (str) – Text for Comment

  • sponsor_or_site (str) – Originator flag for Comment (either _Sponsor_ or _Site_)

property sponsor_or_site

Originator of comment (either Sponsor or Site)

property text

Text content of Comment

class rwslib.builders.clinicaldata.DateTimeStamp(date_time)

The date/time that the data entry, modification, or signature was performed. This applies to the initial occurrence of the action, not to subsequent transfers between computer systems.

date_time

specified DateTime for event

class rwslib.builders.clinicaldata.Flag(flag_type=None, flag_value=None)

A machine-processable annotation on clinical data.

Note

Flag is not supported by Rave

Parameters:
class rwslib.builders.clinicaldata.FlagType(flag_type, codelist_oid=None)

The type of flag. This determines the purpose and semantics of the flag. Different applications are expected to be interested in different types of flags. The actual value must be a member of the referenced CodeList.

Note

FlagType is not supported by Rave

Parameters:

flag_type – Type for Flag

property codelist_oid

Reference to the CodeList for the FlagType

class rwslib.builders.clinicaldata.FlagValue(flag_value, codelist_oid=None)

The value of the flag. The meaning of this value is typically dependent on the associated FlagType. The actual value must be a member of the referenced CodeList.

Note

FlagValue is not supported by Rave

Parameters:

flag_value – Value for Flag

property codelist_oid

Reference to the CodeList for the FlagType

class rwslib.builders.clinicaldata.FormData(formoid, transaction_type=None, form_repeat_key=None, lab_reference=None, lab_type=None)

Models the ODM FormData object

Parameters:

  • formoid (str) – FormDef OID

  • transaction_type (str) – Transaction Type for Data (one of Insert, Update, Upsert, Context, Remove)

  • form_repeat_key (str) – Repeat Key for FormData

  • lab_reference (str) – Name for the Lab with the ranges

  • lab_type (LabType) – Type of the Lab (Central, Local)

annotations: list(Annotation)

Collection of Annotation for FormData - Not supported by Rave

signature: Signature

Signature for FormData

class rwslib.builders.clinicaldata.ItemData(itemoid, value=<class 'rwslib.builders.common.Unset'>, specify_value=None, transaction_type=None, lock=None, freeze=None, verify=None)

Models the ODM ItemData object

Parameters:

  • itemoid (str) – OID for the matching ItemDef

  • value (str) – Value for the ItemData

  • specify_value (str) – ‘If other, specify’ value - Rave specific attribute

  • transaction_type (str) – Transaction Type for Data (one of Insert, Update, Upsert, Context, Remove)

  • lock (bool) – Lock the DataPoint? - Rave specific attribute

  • freeze (bool) – Freeze the DataPoint? - Rave specific attribute

  • verify (bool) – Verify the DataPoint? - Rave specific attribute

annotations

the list of Annotation on the DataPoint - Not supported by Rave

audit_record

the corresponding AuditRecord for the DataPoint

deviations

the list of MdsolProtocolDeviation references on the DataPoint - Rave Specific Attribute

measurement_unit_ref

the corresponding MeasurementUnitRef for the DataPoint

queries

the list of MdsolQuery on the DataPoint - Rave Specific Attribute

class rwslib.builders.clinicaldata.ItemGroupData(itemgroupoid=None, transaction_type=None, item_group_repeat_key=None, whole_item_group=False, annotations=None)

Models the ODM ItemGroupData object.

Note

No name for the ItemGroupData element is required. This is built automatically by the form.

Parameters:

  • transaction_type (str) – Transaction Type for Data (one of Insert, Update, Upsert, Context, Remove)

  • item_group_repeat_key (int) – RepeatKey for the ItemGroupData

  • whole_item_group (bool) – Is this the entire ItemGroupData, or just parts? - Rave specific attribute

  • annotations (list(Annotation) or Annotation) – Annotation for the ItemGroup - Not supported by Rave

signature

Signature for ItemGroupData

class rwslib.builders.clinicaldata.LocationRef(oid)

Reference to a Location

Parameters:

oid (str) – OID for referenced Location

class rwslib.builders.clinicaldata.MdsolProtocolDeviation(value, status, repeat_key=1, code=None, klass=None, transaction_type=None)

Extension for Protocol Deviations in Rave

Note

  • This is a Medidata Rave Specific Extension

  • This primarily exists as a mechanism for use by the Clinical Audit Record Service, but it is useful to define for the builders

Parameters:

  • value (str) – Value for the Protocol Deviation

  • status (rwslib.builder_constants.ProtocolDeviationStatus)

  • repeat_key (int) – RepeatKey for the Protocol Deviation

  • code (basestring) – Protocol Deviation Code

  • klass (basestring) – Protocol Deviation Class

  • transaction_type – Transaction Type for the Protocol Deviation

class rwslib.builders.clinicaldata.MdsolQuery(value=None, query_repeat_key=None, recipient=None, status=None, requires_response=None, response=None, preceding_query_repeat_key=None)

MdsolQuery extension element for Queries at item level only

Note

This is a Medidata Rave specific extension

Parameters:

  • value (str) – Query Value

  • query_repeat_key (int) – Repeat key for Query

  • recipient (str) – Recipient for Query (Marking Group)

  • status (QueryStatusType) – Query status

  • requires_response (bool) – Does this Query need a response?

  • response (str or None) – Query response (if any)

  • preceding_query_repeat_key (int) – Query Key returned by OpenQuery call

property status

Query Status

class rwslib.builders.clinicaldata.ReasonForChange(reason)

A user-supplied reason for a data change.

Parameters:

reason (str) – Supplied Reason for change

class rwslib.builders.clinicaldata.Signature(signature_id=None, user_ref=None, location_ref=None, signature_ref=None, date_time_stamp=None)

An electronic signature applies to a collection of clinical data. This indicates that some user accepts legal responsibility for that data. See 21 CFR Part 11. The signature identifies the person signing, the location of signing, the signature meaning (via the referenced SignatureDef), the date and time of signing, and (in the case of a digital signature) an encrypted hash of the included data.

Parameters:
property signature_id

The ID for the Signature

Note

If a Signature element is contained within a Signatures element, the ID attribute is required.

class rwslib.builders.clinicaldata.SignatureRef(oid)

Reference to a Signature

Parameters:

oid (str) – OID for referenced Signature

class rwslib.builders.clinicaldata.SiteRef(oid, location_oid_type: LocationOIDType | None = None, site_number: str | None = None, study_site_name: str | None = None, site_uuid: str | None = None, location_name: str | None = None, study_env_site_number: str | None = None, previous_location_oid: str | None = None, shared_location_oid: str | None = None, previous_shared_location_oid: str | None = None, subject_created_at_site: str | None = None)

Reference to a Location The default value is SiteName, and the value SiteUUID implies that the LocationOID .. note:: The mdsol:LocationOIDType attribute should be used to indicate the type of LocationOID

Parameters:

  • oid (str) – OID for referenced Location

  • location_oid_type (LocationOIDType) – Type for the oid

  • site_number – Site number

  • study_site_name – Study site name

  • site_uuid – Site UUID

  • location_name – Location name

  • study_env_site_number – Study environment site number

  • previous_location_oid – Previous location OID

  • shared_location_oid – Shared location OID

  • previous_shared_location_oid – Previous shared location OID

  • subject_created_at_site – Subject created at site

class rwslib.builders.clinicaldata.SourceID(source_id)
Information that identifies the source of the data within an originating system.

It is only meaningful within the context of that system.

source_id

specified DateTime for event

class rwslib.builders.clinicaldata.StudyEventData(study_event_oid, transaction_type='Update', study_event_repeat_key=None)

Models the ODM StudyEventData object

Parameters:

  • study_event_oid (str) – StudyEvent OID

  • transaction_type (str) – Transaction Type for Data (one of Insert, Update, Upsert, Context, Remove)

  • study_event_repeat_key (int) – StudyEventRepeatKey for StudyEventData

annotations

Annotation for Study Event Data - Not Supported by Rave

forms

FormData part of Study Event Data

signature

Signature for Study Event Data

class rwslib.builders.clinicaldata.SubjectData(site_location_oid, subject_key, subject_key_type='SubjectName', transaction_type='Update', location_oid_type: LocationOIDType | None = None)

Models the ODM SubjectData and ODM SiteRef objects

Parameters:

  • site_location_oid (str) – SiteLocation OID

  • subject_key (str) – Value for SubjectKey

  • subject_key_type (str) – Specifier as to the type of SubjectKey (either SubjectName or SubjectUUID)

  • transaction_type (str) – Transaction Type for Data (one of Insert, Update, Upsert, Context, Remove)

annotations

collection of Annotation

audit_record

AuditRecord for SubjectData - Not Supported By Rave

location_oid_type

LocationOIDType

signature

Signature for SubjectData

siteref

SiteRef

study_events

collection of StudyEventData

class rwslib.builders.clinicaldata.UserRef(oid)

Reference to a User

Parameters:

oid (str) – OID for referenced User

Administrative Data Builders

Admin Data Builders provide an API for creating ODM AdminData elements

class rwslib.builders.admindata.Address(street_names=None, city=None, state_prov=None, country=None, postal_code=None, other_text=None)

The user’s postal address.

Parameters:

  • street_names (list(Address)) – User street names

  • city (City) – User City

  • state_prov (StateProv) – User State or Provence

  • country (Country) – User City

  • postal_code (PostalCode) – User City

  • other_text (OtherText) – User Other Text

class rwslib.builders.admindata.AdminData(study_oid=None)

Administrative information about users, locations, and electronic signatures.

Parameters:

study_oid (str) – OID pointing to the StudyDef

class rwslib.builders.admindata.City(text)

The city name part of a user’s postal address.

class rwslib.builders.admindata.Country(country_code)

The country name part of a user’s postal address. This must be represented by an ISO 3166 two-letter country code.

class rwslib.builders.admindata.DisplayName(text)

A short displayable name for the user.

class rwslib.builders.admindata.Email(text)

The user’s email address.

class rwslib.builders.admindata.FirstName(text)

The user’s initial given name or all given names.

class rwslib.builders.admindata.FullName(text)

The user’s full formal name.

class rwslib.builders.admindata.LastName(text)

The user’s surname (family name).

class rwslib.builders.admindata.Location(oid, name, location_type=None, metadata_versions=None)

A physical location – typically a clinical research site or a sponsor’s office.

Parameters:

  • oid (str) – OID for the Location, referenced in LocationRef

  • name (str) – Name for the Location

  • location_type (rwslib.builder_constants.LocationType) – Type for this Location

  • metadata_versions (list(MetaDataVersionRef)) – The MetaDataVersionRef for this Location

class rwslib.builders.admindata.LoginName(text)

The user’s login identification.

class rwslib.builders.admindata.MetaDataVersionRef(study_oid, metadata_version_oid, effective_date)
A reference to a MetaDataVersion used at the containing Location.

The EffectiveDate expresses the fact that the metadata used at a location can vary over time.

Parameters:

  • study_oid (str) – References the Study that uses this metadata version.

  • metadata_version_oid (str) – References the rwslib.builders.MetaDataVersion (within the above Study).

  • effective_date (datetime.datetime) – Effective Date for this version and Site

class rwslib.builders.admindata.Organization(text)

The user’s organization.

class rwslib.builders.admindata.OtherText(text)

Any other text needed as part of a user’s postal address.

class rwslib.builders.admindata.Phone(text)

The user’s voice phone number.

class rwslib.builders.admindata.PostalCode(text)

The postal code part of a user’s postal address.

class rwslib.builders.admindata.SimpleChildElement(text)

Generic Element, for elements we’re not ready to flesh out in the builders

class rwslib.builders.admindata.StateProv(text)

The state or province name part of a user’s postal address.

class rwslib.builders.admindata.StreetName(text)

The street address part of a user’s postal address.

class rwslib.builders.admindata.User(oid, user_type=None, login_name=None, display_name=None, full_name=None, first_name=None, last_name=None, organisation=None, addresses=[], emails=[], phones=[], locations=[])
Information about a specific user of a clinical data collection system. This may be an investigator, a CRA, or

data management staff. Study subjects are not users in this sense.

Parameters:
property user_type

User Type :return: