1. Analytics User Guide
  2. Prepare data
  3. Dataset descriptions
  4. Unblinded Kits dataset

Unblinded Kits dataset

You can use the Unblinded Kits dataset to analyze and visualize customized unblinded supply data in Oracle Clinical One Analytics.

Modes

Available in all 3 modes: Testing, Training, and Production

What type of data can I include in an unblinded custom report or visualization?

With this dataset, you can get custom data such as:

  • Kit inventory status at all sites in a study.
  • What kit numbers are included in a shipment and the shipment status.
  • Randomization and treatment arm details for all subjects in a study.
  • Manufacturing and blinded lots status data.
  • Kit dispensation data.

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:

Parent topic: Dataset descriptions

Study folder

This table describes the data elements included in the Study folder

Table 2-67 Data elements in the Study folder

Data element Description
STUDY_MODE Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active.
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 The STUDY_ID_NAME data element that is converted to uppercase and spaces are removed. This value never changes after created even if STUDY_ID_NAME changes.
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.

Parent topic: Unblinded Kits dataset

Site folder

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

Table 2-68 Data elements in the site folder

Data element Description
ADD_SUBJECTS Flag that enables or prevents site users from adding subjects at one or multiple sites.
ADDRESS_CITY A site's city as entered by the site manager when they created or last modified the site.
ADDRESS_COUNTRY A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code.
ADDRESS_POSTALCODE The Zip Postal Code associated with a site's address.
ADDRESS_STATE_OR_PROV_OR_CNTY A site's state, province, or county as entered by the site manager when they created or last modified the site.
ADDRESS_STREET_1 A site's first address as entered by the site manager when they created or last modified the site.
ADDRESS_STREET_2 A site's second address as entered by the site manager when they created or last modified the site.
DEA_NUMBER The DEA registration number.
DISPENSE_TO_SUBJECTS Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites.
DRUG_DESTRUCTION_CAPABLE Flag that defines if the kit type is destructible at the site or not.
EMAIL Email address of the site as entered by the site administrator when they created or last modified the site.
EXPIRATION Indicates the expiration date of the DEA Registration Number as defined by a site manager.
FAX The contact fax number as entered by the site administrator when they created or last modified the site.
INITIAL_SUBJECTS_COUNT Number of initial subjects included in the SDV strategy.
INITIAL_SUBJECTS_SDV_TYPE Type of Source Data Verification: All Questions or Critical Questions.
PHONE The contact phone number as entered by the site manager when they created or last modified the site.
PI_PREFIX The principal investigator's prefix at the site.
RANDOMIZE_SUBJECTS Flag that enables or prevents site users from randomizing subjects at one or multiple sites.
REMAINING_SUBJECTS_PERCENTAGE Number of remaining subjects included in the SDV strategy.
REMAINING_SUBJECTS_SDV_TYPE Type of Source Data Verification: All Questions or Critical Questions.
SCREEN_SUBJECTS Flag that enables or prevents site users from screening subjects at one or multiple sites.
SDV_GROUP_NAME Name of the SDV Strategy, as entered by the study manager.
SHIPPING_ADDRESS_1 A site's first shipping address as entered by the site manager when they created or last modified the site.
SHIPPING_ADDRESS_2 A site's second shipping address as entered by the site manager when they created or last modified the site.
SHIPPING_ATTENTION Indicates the name of the person who will receive shipments at the site, as specified by a site manager.
SHIPPING_CITY City associated with the shipping address, as entered by the site manager when they created or last modified the site.
SHIPPING_COUNTRY Country associated with the shipping address, as entered by the site manager when they created or last modified the site.
SHIPPING_EMAIL Email address associated with the shipping address.
SHIPPING_FAX Fax number associated with the shipping address.
SHIPPING_PHONE Phone number associated with the shipping address.
SHIPPING_STATE_OR_PROV_OR_CNTY State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site.
SHIPPING_ZIP Zip Postal Code associated with the shipping address.
SITE_ID_NAME Indicates the site ID as entered by a site manager when they created or last modified a site.
SITE_STATUS Indicates the status of a site whether it is New, Active, or Retired.
SITE_STUDY_VERSION The study version assigned to the site, as configured by a site manager.
TIMEZONE Indicates the time zone the site is currently placed on as specified by a site manager.
INVESTIGATOR A Principal Investigator's Full Name as listed when the site manager created the site.
SITE_NAME Indicates the site's name as entered by a site manager when they created or last modified a site.
SITE_TYPE Indicates the type of organization.

Parent topic: Unblinded Kits dataset

Country folder

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

Table 2-69 Data elements in the Country folder

Data element Description
COUNTRY_NAME Indicates a country's two-digit ISO code.

Parent topic: Unblinded Kits dataset

Subject folder

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

Table 2-70 Data elements in the Subject folder

Data element Description
SUBJECT_NUMBER The number currently assigned to the subject in the system as identifier.
SUBJECT_STATE A subject's state.
PREVIOUS_SUBJECT_NUMBER When a subject number change is applied, this field holds the number that was assigned to the subject before the change.

Parent topic: Unblinded Kits dataset

Event folder

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

Table 2-71 Data elements in the event folder

Data element Description
VISIT_IS_REQUIRED Indicates whether or not a visit is required.
IS_SCHEDULED_VISIT Indicates whether the visit is scheduled or not.
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_STATUS Indicates a visit's status in the system.

Future visits are included with the status of 'SCHEDULED'. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.
VISIT_START_DATE Date stamp of a visit's start date.
VISIT_TYPE Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion.
EVENT_TYPE Displays the type of event (visit started, visit completed).
PROJECTED_VISIT_DATE Date when the next scheduled dispensation should take place in the study.
PROJECTED_VISIT_END_DATE Date when the next scheduled dispensation should end in the study.
PROJECTED_VISIT_START_DATE Date when the next scheduled dispensation should start in the study.
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_ID_NAME The event's id as in Oracle Clinical One Platform.
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_TITLE The event's title, defined by the user when an event is created.
VISIT_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: Unblinded Kits dataset

Randomization folder

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

Table 2-72 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.

RERANDOMIZATION

Indicates whether the study designer chose to use the current randomiation 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.

RAND_NUMBER

Indicates the randomization number assigned to each randomized subject in a study.

RND_STATUS
Indicates whether a subject has been randomized or not in a study. If randomized, a subject's status must be updated to Active. If a subject is not randomized, their status can be:
  • New: If they're newly enrolled in the study at the time that you are creating a report using this data element.
  • Screened: If they're screened in the study at the time that you are creating a report using this data element.
  • Enrolled: If they're enrolled in the study at the time that you are creating a report using this data element, but they have been screened in a different system outside of Oracle Clinical One Platform.

RANDOMIZATION_DATE

Indicates the date on which a subject has been randomized in the study.

Parent topic: Unblinded Kits dataset

Lot folder

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

Table 2-73 Data elements in the lot folder

Data element Description

MANFACTURING_LOT_TITLE

Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot.

BLINDED_LOT_TITLE

Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot.

BLINDED_LOT_DO_NOT_COUNT_DAYS

Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot.

BLINDED_LOT_DO_NOT_SHIP_DAYS

Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot.

BLINDED_LOT_EXPIRATION_DATE

Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot.

BLINDED_LOT_SHORT_NAME

Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot.

A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name.

MANFACTURING_LOT_SHORT_NAME

Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot.

A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot.

MANFACTURING_LOT_DO_NOT_COUNT_DAYS

Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot.

MANFACTURING_LOT_DO_NOT_SHIP_DAYS

Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot.

MANFACTURING_LOT_EXPIRATION_DATE

Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot.

Parent topic: Unblinded Kits dataset

Shipment folder

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

Table 2-74 Data elements in the shipment folder

Data elements Description

SHIPMENT_NAME

Indicates a shipment's full name.

SHIPMENT_STATUS
Indicates the status of a shipment, as updated by the system or by a user in the study:
  • Pending
  • In Transit
  • Received
  • Cancelled
  • Lost
  • Confirmed
  • Invalid
  • Pending Destruction
  • Received for Destruction
  • Destroyed

SHIPMENT_CREATED_DATE
Indicates the date a shipment was created, whether it is a:
  • Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC).
  • Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle Project Manager). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC).

SHIPMENT_DATE

Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot.

TRACKING_NUMBER

Indicates a shipment's tracking number, as specified by the depot user.

Parent topic: Unblinded Kits dataset

Kits (Required) folder

This table describes the data elements included in the Kit (Required) folder.

Table 2-75 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:

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.

MINIMUM_KITS_TO_SHIP

Indicates the minim number of kits to include in each shipment to meet pacakinging 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.

BALANCE_UNITS

Indicates the total units of a kit minus the missing and returned units.

TITRATION

Indicates if a kit type is part of a kit type titration or not. Values can be 1 or 0.

KIT_NUMBER

Indicates a kit's number, as assigned in the system.

KIT_DESCRIPTION

Indicates a kit's description, as specified by the study designer when they created the kit type.

DISPENSATION_DATE

Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject.

DOSAGE

Indicates the dosage for the dispensed kit, when the kit contains calculated doses.

BAR_CODE

If included in a study, this indicates a kit's barcode as generated by the sysem.

DISPENSATION_CONFIRMED

Indicates whether a kit's dispensation was confirmed by a site user or not

MEASUREMENT

Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer

FREQUENCY

Indicates the dosing frequency as defined by a study designer

RETURNED_UNITS

Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA)

MISSING_UNITS

Number of lost or damaged units in the kit as indicated by the site user

CONSERVED

Indicates whether a kit was conserved by a site user or not

QUANTITY

Indicates a kit's quantity, as specified by the study designer.

INSTANCE_NUMBER

Indicates the repeat instance number of the visit

TRIAL_SUPPLY_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

SINGLE_UNIT_DOSE_VALUE

Indicates how one unit in the kit is measured, specifically its specified value.

CRA_VERIFIED

Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA).

KIT_STATUS

Indicates a kit's status in the study's inventory.

For more information on what a kit's status may be, see What statuses can kits have?.

VERIFIED_BY

Indicates the user who verified data associated with a question, a form, or a visit.

VERIFIED_DATE

Indicates the date when a question, form, or visit was verified. Date is displayed in UTC.

CONFIRMED_BY

Indicates the email address of the user who confirmed the dispensation of a specified kit.

CONFIRMED_DATE

Indicates the date at which a specified kit's dispenstion was confirmed.

SEQUENCE_NUMBER

Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence.

BLOCK_NUMBER

Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs.

ITEM_NUMBER
Numeric value used as a reference element for batch processing.

Note:

This field is part of the SAP system and populated via integration. This field does not display in Oracle Clinical One Platform.

MATERIAL_ID
Alphanumeric identifier of the material of a given kit, used as a refrence element for batch processing.

Note:

This field is part of the SAP system and populated via integration. This field does not display in Oracle Clinical One Platform.

Parent topic: Unblinded Kits 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.

DOSE_FREQUENCY

Indicates how many doses the subject must consume, 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.

DOSE_PRECISION

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.

DOSE_ROUND_UP

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.

DOSE_LEFT_OVER_UNITS

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.

Parent topic: Unblinded Kits dataset

Audit folder

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

Table 2-76 Datat elements in the audit folder

Data element Description
VERSION_START Indicates the date and time of when the data was changed.
VERSION_END Indicates the date and time of when data was changed, if the data is not current.
OPERATION_TYPE Audit trail field that represents the type of operation performed (i.e. create, modify).
OBJECT_VERSION_NUMBER Audit trail field that represents the version number of the data.
REASON Indicates a reason for changes in a subject's data. Populated by drop-down list.
COMMENTS Required comment in a reason for change if ‘Other’ is selected. Populated as Rule Execution for calculated values.
USER_NAME

Audit trail field that represents the user who performed the action.

The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS.

IS_CURRENT Audit trail field to display either current status or full audit trail of the data.
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: Unblinded Kits dataset

Reference folder

Data element Description

SITE_WID

A number that represents the unique identifier of a site.

STUDY_WID

A number that represents the unique identifier of the study.

SUBJECT_WID

Indicates a subject's numeric identifier.
COUNT Represents the count of kits.

COHORT_WID

Indicates a cohort's numeric identifier.

INVENTORY_WID

Indicates the numeric identifier of the study's inventory.

KIT_DESIGN_WID

Indicates the numeric identifier of a kit's design.

SHIPMENT_WID

A number that represents the unique identifier of a shipment.

TREATMENT_WID

A number that represents the unique identifier of a treatment arm.

USER_WID

Indicates a user's numeric identifier.

EVENT_WID

A number that represents the unique identifier of an event.

CALCULATED_DOSE_WID

Indicates the numeric identifier of a kit containing calculated doses.

VERIFIED_BY_WID

Indicates the numeric identifier of a user who verified data associated with a visit.

CONFIRMED_BY_WID

Indicates the numeric identifier of a user who confirmed the dispensation of a kit during a visit.

SOFTWARE_VERSION_NUMBER

A number that represents an incremental increase every time a data point is modified.

DH_TIMESTAMP

A timestamp that indicates when the data became available in the dataset.

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: Unblinded Kits dataset