Kits and Randomization Design dataset

You can use the Kits and Randomization Design dataset to analyze and visualize data in Oracle Clinical One Analytics regarding the metadata of kit definition, dispensation schedule and randomization definition for the study.

Modes

This dataset displays kits and randomization design details of a study version available in any mode.

What type of data can I include in a custom report or visualization on Kits and Randomization design?

With this dataset you can:

Identify the kits and randomization configurations
Identify randomization and dispensation visits
Identify dispensation schedules

For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.

Browse description of data elements included in this dataset:

Note:

Blank columns in Oracle Clinical One Analytics indicate null or not applicable.

Tip:

In order for Oracle Clinical One Analytics to perform optimally, begin by adding data elements from the Required folder to your workbook. For more information, see Create and edit a data visualization.

Parent topic: Dataset descriptions

Study folder

This table describes the data elements included in the Study folder

Table 2-22 Data elements in the Study folder

Data element	Description
STUDY_ID_NAME	A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number.
STUDY_TITLE	A protocol's title as specified by the study manager.
STUDY_REFNAME	Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed.
STUDY_PHASE	A study's phase as indicated by the study manager when they created the study.
THERAPEUTIC_AREA	Indicates the therapeutic area as specified by the study manager when they created the study.
BLINDING_TYPE	Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study.
STUDY_VERSION	Indicates the study version number of the referencing data in a custom report.
STUDY_DESIGN_STATUS	Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active.
DH_TIMESTAMP	A timestamp that indicates when the data became available in the dataset.
MODIFIED_BY	The user who last modify the study.
VERSION_END	Indicates the date and time of when data was changed, if the data is not current.
VERSION_START	Indicates the date and time of when the data was changed.

Parent topic: Kits and Randomization Design dataset

Randomization folder

This table describes the data elements included in the Randomization folder.

Table 2-23 Data elements in the randomization folder

Data elements	Description
RANDOMIZATION_TITLE	Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode.
RANDOMIZATION_DESCRIPTION	Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode.
RANDOMIZATION_TYPE	Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if blinded users should always see the titles of the treatment arms used in the randomization design.
COHORT_NAME	Indicates the type of cohort selected by a study designer when creating a randomization design: None: this indicates that the study has no cohorts Adaptive: this indicates that the study contains cohorts that allow site staff to open treatment arms in a gradual manner so that the study team can better measure safety and efficacy as the study progresses. Demography: this indicates that the study contains population groups according to demographic criteria, such as age.
COHORTTYPE	Indicates the type of cohort selected by a study designer when creating a randomization design: None: this indicates that the study has no cohorts Adaptive: this indicates that the study contains cohorts that allow site staff to open treatment arms in a gradual manner so that the study team can better measure safety and efficacy as the study progresses. Demography: this indicates that the study contains population groups according to demographic criteria, such as age.
RERANDOMIZATION	Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0.
TREATMENT_ARM_TITLE	Indicates the title of the treatment arm from the protocol, as specified by the study designer when they created the treatment arm in Study Design mode. Displays the title for every treatment arm created in the study.
TREATMENT_ARM_DESCRIPTION	Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode.
TREATMENT_ARM_ID	Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm.
RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES	Indicates the option that a study designer chose (Yes or No) when configuring this setting. Yes: Indicates that the study designer created the randomization to skip the randomization number for an out-of-stock kit and assign the randomization number for the next available kit. No: Indicates that a study designer chose not to restrict the randomization to available kit types, determining a randomization failure to occur when there are no available kit types in the study for a site user to randomize a subject.
ASSIGN_SKIPPED_RANDOMIZATION_NUMBERS	Indicates the option that a study designer chose (Yes or No) when configuring this setting. Yes: indicates that, when a randomization number is skipped because its kit is not in stock, the skipped randomization number is assigned to a subject who enrolls after the out-of-stock kit is available again. No: indicates that skipped randomization numbers are never assigned to subjects.
RANDOMIZATION_VERSION_START	Indicates the date and time of when the randomization data was entered.
RANDOMIZATION_VERSION_END	Indicates the date and time of when randomization data was changed, if the data is not current.

Parent topic: Kits and Randomization Design dataset

Event folder

This table describes the data elements included in the event folder.

Table 2-24 Data elements in the event folder

Data element	Description
VISIT_IS_REQUIRED	Indicates if a visit is required.
IS_SCHEDULED_VISIT	Indicates if the visit is scheduled.
SCHEDULED_FROM_EVENT_NAME	Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule.
VISIT_TYPE	Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion.
EVENT_TYPE	Displays the type of event that primarly impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete Visit_Date_Changed VisitDateCleared VisitDateEntered Visit_Not_Started Visit_Skip_Undone Visit_Skipped Visit_Started Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
DELAY_DAYS	The number of days between the prior scheduled visit.
DELAY_HOURS	The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field).
VISIT_WINDOW_AFTER_DAYS	Indicates how many days after the scheduled date and time the visit can occur.
VISIT_WINDOW_AFTER_HOURS	Indicates how many hours after the scheduled date and time the visit can occur.
VISIT_WINDOW_BEFORE_DAYS	Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer.
VISIT_WINDOW_BEFORE_HOURS	Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer.
EVENT_TITLE	The event's title, defined by the user when an event is created.
EVENT_REFNAME	The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version.
EVENT_ID_NAME	The event's id as in Oracle Clinical One Platform.
VISIT_HOUR_SEQ_ORDER	The order in which subject visits occur, as configured in the study design.
SCHEDULED_FROM_EVENT_REFNAME	Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit’s own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule.

Parent topic: Kits and Randomization Design dataset

Kit folder

This table describes the data elements included in the Kit folder.

Table 2-25 Data elements in the kit folder

Data element	Description
KIT_TYPE	A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation Product Device Kit Type Titration For more information on these kit types, see the following topics: Define the kits for investigational products Define the kits for devices Define how subjects titrate
DEVICE_TYPE	Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch Blood Pressure Monitor Glucose Monitor Weight Scale ECG Reader Spirometer Mobile App Smart Pill Bottle Pulse Oximeter Wearable Patch Other
DEVICE_CONNECTION	Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No Connection Device to Cloud Cloud to Cloud For more information on what each connection consists of, see Define the kits for devices.
CALCULATING_DOSES	Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. The values following values can be displayed: 1 or 0.
DISTRIBUTION_SETTINGS	Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: if blinded users should never see the kit type description. Unblinded: if blinded users should always see the kit type description. Unblinded Pharmacist: if blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
KIT_TYPE_ID	Indicates the unique identifier for a kit type.
TYPE	Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack Bottle Device Syringe Topical Ointment Vial Inhaler Infusion Box Other
MINIMUM_KITS_TO_SHIP	Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type.
UNITS_PER_KIT	Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products.
SINGLE_UNIT_DOSE_UNITS	Indicates how one unit in the kit is measured.
SINGLE_UNIT_DOSE_VALUE	Indicates how one unit in the kit is measured, specifically its specified value.
TITRATION	Indicates if a kit type is part of a kit type titration. Values can be 1 or 0.
KIT_VERSION_START	Indicates the date and time of when the kit data was entered.
KIT_VERSION_END	Indicates the date and time of when kit data was changed, if the data is not current.

Parent topic: Kits and Randomization Design dataset

Calculated dose folder

This table describes the data elements included in the Calculated dose folder.

Note:

For more information on each of these data elements, see Define kits with calculated doses.

Data element	Description
CALCULATED_DOSE_TITLE	Indicates the title of the kit type containing calculated doses, as specified by the study designer.
FORM_QUESTION_FOR_CALCULATED_DOSE	Indicates the question that is selected by the study designer to be used in calculating the appropriate dose.
VISIT_WHERE_FORM_IS_COLLECTED	Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer.
PRECISION_FOR_EACH_DOSE	Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4.
ROUND_UP_FOR	Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Oracle Clinical One Platform): For the dose precision, the number 4 is displayed (this value represents the number of places after the decimal point). For the dose round up, the number 6 is displayed.
DOSING_FREQUENCY	Indicates how many doses the subject must consume, as specified by the study designer.
USE_LEFTOVER_UNITS_IN_NEXT_DOSE	Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer.
KIT_MEASUREMENT	Indicates the total numeric value for the product in the kit, as specified by the study designer.
SUBJECT_MEASUREMENT	Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer.

Parent topic: Kits and Randomization Design dataset

Reference folder

This table describes the data elements in the Reference folder.

Table 2-26 Data elements in the reference folder

Data element	Description
STUDY_WID	A number that represents the unique identifier of the study.
COHORT_WID	Indicates a cohort's numeric identifier.
KIT_WID	Indicates the numeric identifier of a kit.
MODIFIED_BY_WID	The unique numeric identifier of the user who modified the study.
ARM_WID	A number that represents the unique identifier of a treatment arm.
STUDYEVENT_WID	A number that represents the unique identifier of an event.
RAND_WID	Indicates the numeric identifier of the randomization design.
CURRENT_STUDY_ROLE_WID	Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user.

Parent topic: Kits and Randomization Design dataset

Audit folder

This table describes the data elements included in the Audit folder.

Table 2-27 Datat elements in the audit folder

Data element	Description
CURRENT_STUDY_ROLE_NAME	Specifies of the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user.

Parent topic: Kits and Randomization Design dataset