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

Blinded Kits dataset

Use this dataset to analyze and visualize data and the audit history of specific kits in the study, from management and dispensation, without viewing details that could potentially unblind users.

In Oracle Clinical One Platform you can define kits to be Blinded, Unblinded (open label) or Unblinded Pharmacist for distribution. This dataset includes data about both blinded and unblinded kits, but omits details that may compromise the integrity of the study blind, such as treatment arm information. Data from unblinded pharmacist kits is not available in this dataset. To work with unblinded pharmacists kits and other unblinded data see Unblinded Kits dataset.

Modes

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

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

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

  • Blinded kit inventory status at all sites in a study.

    Note:

    Non-serialized kits are managed in bulk and only display the current status for a count of kits grouped in a lot. To track each kit individually, you need to use serialized kits.
  • What kit numbers are included in a shipment and the shipment status.
  • Randomization blinded details for all subjects in a study.
  • Blinded lots status blinded data.
  • Kit dispensation blinded 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:

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 2-1 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 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.

Parent topic: Blinded Kits dataset

Site folder

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

Note:

Only a site's primary address is transmitted to Oracle Clinical One Analytics.

Table 2-2 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.
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 The first line of a site's shipping address as entered by the site manager when they created or last modified the site.
SHIPPING_ADDRESS_2 The second line of 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: Blinded Kits dataset

Country folder

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

Table 2-3 Data elements in the Country folder

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

Parent topic: Blinded Kits dataset

Subject folder

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

Table 2-4 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.
SCREENING_NUMBER Always displays the original screening number, assigned to the subject at screening.

Parent topic: Blinded Kits dataset

Event folder

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

Table 2-5 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_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 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.
PROJECTED_VISIT_START_DATE Date when the next scheduled visit should start in the study, based on the configured visit schedule.
PROJECTED_VISIT_END_DATE Date when the next scheduled visit should end in the study, based on the configured visit schedule.
PROJECTED_VISIT_DATE Date when the next scheduled visit should take place in the study, based on the configured visit schedule.
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_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.
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.
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_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: Blinded Kits dataset

Randomization folder

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

Table 2-6 Data elements in the randomization folder

Data elements Description

RAND_NUMBER

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

Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings.

RANDOMIZATION_DATE

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

Parent topic: Blinded Kits dataset

Lot folder

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

Table 2-7 Data elements in the lot folder

Data element Description

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_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.

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.

Parent topic: Blinded Kits dataset

Shipment folder

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

Table 2-8 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 point of contact). 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.

SHIPMENT_RECEIPT_DATE

Indicates the date on which the shipment was received.

SHIPMENT_RECEIVED_BY

Indicates the user who received the given shipment.

TRACKING_NUMBER

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

Parent topic: Blinded Kits dataset

Kits (Required) folder

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

Table 2-9 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.

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

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.

CRA_VERIFIED

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

BALANCE_UNITS

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

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?.

KIT_NUMBER

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

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 bar code as generated by the system.

DISPENSATION_CONFIRMED

Indicates whether a kit's dispensation was confirmed by a site user.

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.

QUANTITY

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

INSTANCE_NUMBER

Indicates the repeat instance number of the visit.

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 dispensation was confirmed.

Parent topic: Blinded Kits dataset

Audit folder

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

Table 2-10 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.

Parent topic: Blinded Kits dataset

Reference folder

This table describes the data elements in the Reference folder.

Table 2-11 Data elements in the reference folder

Data element Description

STUDY_WID

A number that represents the unique identifier of the study.

SITE_WID

A number that represents the unique identifier of a site.

SUBJECT_WID

Indicates a subject's numeric identifier.

EVENT_WID

A number that represents the unique identifier of an event.

COHORT_WID

Indicates a cohort's numeric identifier.

SHIPMENT_WID

A number that represents the unique identifier of a shipment.

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.

USER_WID

Indicates a user's numeric identifier.

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.

Parent topic: Blinded Kits dataset