Unblinded Kits dataset

You can use the Unblinded Kits dataset to analyze and visualize data and the audit history of specific kits in the study, from management and dispensation. This dataset includes information that could potentially unblind a user.

In Clinical One Cloud Service you can define kits to be Blinded, Unblinded (open label) or Unblinded Pharmacist for distribution. This dataset includes data about all blinded, unblinded and unblinded pharmacist kits, including details that may compromise the integrity of the study blind, such as treatment arm information. To work with blinded data see Blinded Kits dataset.

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.

    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 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:

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 3-79 Data elements in the Study folder

Data element Description
STUDY_MODE Indicates the study mode used in the referencing data in a custom report. Values can be
  • Testing
  • Training
  • Active
STUDY_ID_NAME

The study ID as specified when the study was created. The study ID typically includes the protocol acronym or protocol number and must be unique within a tenant.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

STUDY_TITLE

The Study Title as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

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

The study phase as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The study phase is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.studyPhase codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

THERAPEUTIC_AREA

Indicates the therapeutic area as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The therapeutic area is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.therapeuticArea codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

BLINDING_TYPE Indicates the blinding type of the study (whether the study is open-label or blinded) as specified when the study was created.

You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.

The blinding type is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.openLableBlinded codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.

Parent topic: Unblinded Kits dataset

Site folder

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

Note:

A site may have multiple addresses added that are used for different purposes (primary address, shipping address, billing address, alternate address), but only one address can and must be configured as the main primary address.
  • Only a site's main primary address is transmitted to Oracle Clinical One Analytics for the address data elements (those starting with ADDRESS_).
  • The shipping address data elements (those staring with SHIPPING_) return the site's shipping address details only if added in Clinical One Cloud Service, otherwise it will return null.

    If a site has multiple shipping addresses, only the first entered shipping address is transmitted to Oracle Clinical One Analytics.

Table 3-80 Data elements in the site folder

Data element Description
ADD_SUBJECTS Setting defined at the study site level to allow site users to add subjects. Values can be:
  • true
  • false
ADDRESS_CITY The city of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_COUNTRY

The country of the site's main primary address, as entered when the site was created or last modified.

This field displays the country's two-digit ISO code.
ADDRESS_POSTALCODE The zip postal code of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STATE_OR_PROV_OR_CNTY The state, province or county of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STREET_1 The first line of the site's main primary address, as entered in the Address Line 1 field when the site was created or last modified.
ADDRESS_STREET_2 The second line of the site's main primary address, as entered in the Address Line 2 field when the site was created or last modified.
DEA_NUMBER The DEA registration number of the site's contact.
DISPENSE_TO_SUBJECTS Setting defined at the study site level to allow site users to dispense kits to subjects. Values can be:
  • true
  • false
DRUG_DESTRUCTION_CAPABLE Indicates if the site has drug destruction capabilities. Values can be:
  • true
  • false
EMAIL The email address associated to the site's main primary address, as entered when the site was created or last modified.
EXPIRATION The expiration date of the DEA registration number of the site's contact.
FAX The fax number associated to the site's main primary address, as entered when the site was created or last modified.
INITIAL_SUBJECTS_COUNT Total count of initial subjects in a site that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
INITIAL_SUBJECTS_SDV_TYPE Type of Source Data Verification (SDV) applied to initial subjects, as defined in the SDV strategy. Values can be:
  • All Questions - meaning all questions must be verified for the subject.
  • Critical Questions Only - meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
PHONE The phone number associated to the site's main primary address, as entered when the site was created or last modified.
PI_PREFIX Indicates the prefix for the site's principal investigator. Values can be:
  • First Liutenant
  • Admiral
  • Attorney
  • Brother
  • Captain
  • Chief
  • Commander
  • Colonel
  • University Dean
  • Doctor
  • Elder
  • Father
  • General
  • Fees
  • Honorable
  • Liutenant Colonel
  • Major
  • Major/Master Sergeant
  • Mister
  • Married Woman
  • Single or Married Woman
  • Prince
  • Professor
  • Rabbi
  • Reverend
  • Sister
RANDOMIZE_SUBJECTS Setting defined at the study site level to allow site users to randomize subjects. Values can be:
  • true
  • false
REMAINING_SUBJECTS_PERCENTAGE Percentage of remaining subjects in a site, after the initial subjects, that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
REMAINING_SUBJECTS_SDV_TYPE Type of Source Data Verification (SDV) applied to the remaining subjects, as defined in the SDV strategy. Values can be:
  • All Questions - meaning all questions must be verified for the subject.
  • Critical Questions Only - meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
SCREEN_SUBJECTS Setting defined at the study site level to allow site users to screen subjects. Values can be:
  • true
  • false
SDV_GROUP_NAME Name of the SDV strategy that is associated with the site. This name is entered by the user when creating an SDV strategy.
SHIPPING_ADDRESS_1 The first line of the site's shipping address, as entered in the Address Line 1 field when the site was created or last modified.
SHIPPING_ADDRESS_2 The second line of the site's shipping address, as entered in the Address Line 2 field when the site was created or last modified.
SHIPPING_ATTENTION Indicates the name of the person who will receive shipments at the site, as specified when the site was created or last modified.
SHIPPING_CITY The city of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_COUNTRY The country of the site's shipping address, as entered when the site was created or last modified. This field displays the country's two-digit ISO code.
SHIPPING_EMAIL The email address associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_FAX The fax number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_PHONE The phone number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_STATE_OR_PROV_OR_CNTY The state, province, or county of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_ZIP The zip postal code of the site's shipping address, as entered when the site was created or last modified.
SITE_ID_NAME The site ID, as entered when the site was created or last modified.
SITE_STATUS Indicates the status of the site within the study. Values can be:
  • New: the site is new within the study.
  • Active: the site is currently active within the study.
  • Retired: the site is no longer active in the study.
SITE_STUDY_VERSION The latest study version associated with the site. This is defined in the Sites & Labs tab of the study's settings.
TIMEZONE Indicates the time zone for the site, as specified when the site was created or last modified.

Values can be, for example, EST5EDT or America/New_York. Depends on the selected value in Clinical One Cloud Service.

INVESTIGATOR Last name of the principal investigator associated with the site.
SITE_NAME Name of the site, as entered when the site was created or last modified.
SITE_TYPE Indicates the type of organization. Values can be:
  • Site
  • Depot

Parent topic: Unblinded Kits dataset

Country folder

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

Table 3-81 Data elements in the Country folder

Data element Description
COUNTRY_NAME The country of the site's main primary address, as entered when the site was created or last modified.

This field displays the 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 3-82 Data elements in the Subject folder

Data element Description
SUBJECT_NUMBER

The number currently assigned to the subject in the system as identifier.

Note: NULL is displayed if a subject was removed using the Undo Add Subject feature.
SUBJECT_STATE A subject's state in Clinical One Cloud Service.
Note:
  • When a subject is Screened, Oracle Clinical One Analytics displays screening_initiated until the next visit is complete and the subject becomes Active.
  • When a subject is Screen Failed , Oracle Clinical One Analytics displays auto_screen_failed.
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: Unblinded Kits dataset

Event folder

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

Table 3-83 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, if it is the first visit in the schedule.

VISIT_STATUS Indicates a visit's status in the system. Can have one of the following values:
  • COMPLETED: all required items within the visit are completed and there are no open queries.
  • COMPLETED_ERR: all required items within the visit are completed but there are open queries.
  • INCOPLETE: the visit was completed at some point but now has one or more required items that are not completed.
  • INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.
  • IN_PROGRESS: the visit was never completed and has one or more required items with no saved data.
  • NEW: the visit was either dynamically triggered or added as part of Advanced Study Versioning (ASV) and has no data.
  • SCHEDULED: the visit is scheduled for the subject but has no data.

    Note: 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.

  • SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.
  • UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
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
  • Study Completion
EVENT_TYPE
Displays the type of event that 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_DATE Date when the next scheduled visit should take place 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_START_DATE Date when the next scheduled visit should start 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_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 Clinical One Cloud Service.
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 Clinical One Cloud Service 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 that visit’s own refname..

Parent topic: Unblinded Kits dataset

Randomization folder

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

Table 3-84 Data elements in the randomization folder

Data elements Description

RANDOMIZATION_TITLE

 s

Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service.

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 users should be aware of the titles of the treatment arms used in the randomization design.

COHORT_NAME

Indicates the name of the cohort as defined by the study designer when creating a randomization design.

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 in Clinical One Cloud Service. 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 subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.
  • No: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.

ASSIGNED_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 due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.
  • 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.

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.

RND_STATUS
Represents the status of the subject's randomization number. Values can be:
  • Assigned
  • Randomized in error

RANDOMIZATION_DATE

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

FORCED_RAND
Indicates whether the subject underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study. This scenario can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization. For this data element, the following values can be displayed:
  • Y: indicates that a subject underwent forced randomization.
  • N: indicates that a subject was randomized normally.
  • NULL: indicates that a subject has not yet been randomized.

Parent topic: Unblinded Kits dataset

Lot folder

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

Table 3-85 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 3-86 Data elements in the shipment folder

Data elements Description

COMPOUNDING_KITS

 Indicates whether a shipment contains compounding kits:
  • Y: the shipment does contain compounding kits.
  • N: the shipment does not contain compounding kits.

ORDER_TYPE

 Indicates how a shipment was initiated:
  • INITIAL
  • MANUAL
  • RESUPPLY

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_NAME

Indicates a shipment's full name.

SHIPMENT_RCVD_SITE_DEPOT_DATE

 Indicates the Registered On (UTC) date from the Shipments tab and indicates when a shipment was registered in Clinical One Cloud Service, regardless of shipment type (depot to site, site to depot, or depot to depot). For more information, see Register a shipment.

SHIPMENT_RECEIPT_DATE

Initially indicates the Registered On (UTC) date at the time of shipment registration and updates to reflect the Received On (UTC) date if the Received On (UTC) is modified. Fore more information, see Register a shipment.

SHIPMENT_RECEIVED_BY

Indicates the user name of the person who registered the shipment. For more information, see Register a shipment

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

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 3-87 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 calculated doses defined based on subjects' answers to one or more questions.

The 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 users should always be aware of 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 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. For example: g, mg, ml, etc.

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. 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 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.

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 the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule.

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 inventory data.

VERIFIED_DATE

Indicates the date when inventory 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.

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 Clinical One Cloud Service.

MATERIAL_ID

Alphanumeric identifier of the material of a given kit, 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 Clinical One Cloud Service.
COUNT_OF_KITS The total count of kits.
IS_NON_SERIALIZED_KIT Indicates if the kit is non serialized:
  • Y (Yes) the kit is non-serialized.
  • N (No) the kit is serialized.

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 Clinical One Cloud Service):
  • 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 3-88 Data elements in the audit folder

Data element Description
VERSION_START

Indicates the date and time of when the data was changed.

This data element indicates the first timestamp in the system where it was known that the subject should be completing that form for the following scenarios:
  • For dynamic forms, this is when the form is triggered.
  • For forms in scheduled visits, the temporal information matches the timestamp of the visit that contains it, and this information comes from the study design.
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 on the record:
  • CREATED
  • MODIFIED
  • REMOVED
  • CLEARED

Note: For form records in skipped visits, OPERATION_TYPE is set to CLEARED.
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.
Note:
  • For repeating forms, 2-section, and lab forms, this element is associated with both form-level records and row-level records.
  • For form records in skipped visits, forms are not current and IS_CURRENT is set to N.
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

CALCULATED_DOSE_WID

Indicates the numeric identifier of a kit containing calculated doses.

COHORT_WID

Indicates a cohort's numeric identifier.

CONFIRMED_BY_WID

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

COUNT

Represents the count of records 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.

DH_TIMESTAMP

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

EVENT_WID

A number that represents the unique identifier of an event.

INVENTORY_WID

Indicates the numeric identifier of the study's inventory.

KIT_DESIGN_WID

Indicates the numeric identifier of a kit's design.

SHIPMENT_RECEIVED_BY_WID

Indicates the numeric identifier of the user who registered the shipment. For more information, see Register a shipment.

SHIPMENT_WID

A number that represents the unique identifier of a shipment.

SITE_WID

A number that represents the unique identifier of a site.

SOFTWARE_VERSION_NUMBER

A number that increases incrementally every time a data point is modified.

STUDY_WID

A number that represents the unique identifier of the study.

SUBJECT_WID

Indicates a subject's numeric identifier.

TREATMENT_WID

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

USER_WID

Indicates a user's numeric identifier.

VERIFIED_BY_WID

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

Parent topic: Unblinded Kits dataset