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.
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.
Note:
Blank columns in Oracle Clinical One Analytics indicatenull
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.- Study folder
- Site folder
- Country folder
- Subject folder
- Event folder
- Randomization folder
- Lot folder
- Shipment folder
- Kits (Required) folder
- Calculated dose folder
- Audit folder
- Reference folder
Parent topic: Dataset descriptions
Study folder
This table describes the data elements included in the Study folder
Table 2-69 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: Unblinded 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 2-70 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 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: Unblinded Kits dataset
Country folder
This table describes the data elements included in the Country folder.
Table 2-71 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 2-72 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: Unblinded Kits dataset
Event folder
This table describes the data elements included in the event folder.
Table 2-73 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:
|
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 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 2-74 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:
|
COHORT_NAME |
Indicates the type of cohort selected by a 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 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.
|
ASSIGN_SKIPPED_RANDOMIZATION_NUMBERS |
Indicates the option that a study designer chose (Yes or No) when configuring this setting.
|
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 |
Indicates whether a subject has been randomized or not in a study.
|
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 2-75 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 2-76 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:
|
SHIPMENT_CREATED_DATE |
Indicates the date a shipment was created, whether it is a:
|
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 2-77 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:
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:
|
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:
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:
|
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. |
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:
|
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 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 Oracle Clinical One Platform. |
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 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):
|
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 2-78 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