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.
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.
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
- Audit folder
- Reference folder
Parent topic: Dataset descriptions
Study folder
This table describes the data elements included in the Study folder
Table 3-1 Data elements in the Study folder
| Data element | Description |
|---|---|
| STUDY_MODE | Indicates the study mode used in the referencing data in a custom report. Values can be
|
| 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: Blinded Kits dataset
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 returnnull.If a site has multiple shipping addresses, only the first entered shipping address is transmitted to Oracle Clinical One Analytics.
Table 3-2 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:
|
| 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:
|
| DRUG_DESTRUCTION_CAPABLE | Indicates if the site has drug destruction capabilities. Values can be:
|
| 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:
|
| 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:
|
| RANDOMIZE_SUBJECTS | Setting defined at the study site level to allow site users to randomize subjects. Values can be:
|
| 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:
|
| SCREEN_SUBJECTS | Setting defined at the study site level to allow site users to screen subjects. Values can be:
|
| 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:
|
| 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:
|
Parent topic: Blinded Kits dataset
Country folder
This table describes the data elements included in the Country folder.
Table 3-3 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: Blinded Kits dataset
Subject folder
This table describes the data elements included in the Subject folder.
Table 3-4 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:
|
| 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 3-5 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, 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:
|
| VISIT_START_DATE | Date stamp of a visit's start date. |
| VISIT_TYPE | Displays the type of visit:
|
| 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:
|
| 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 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_ID_NAME | The event's id as in Clinical One Cloud Service. |
| 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: Blinded Kits dataset
Randomization folder
This table describes the data elements included in the Randomization folder.
Table 3-6 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 |
Represents the status of the subject's randomization number. Values can be:
|
|
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. |
Parent topic: Blinded Kits dataset
Lot folder
This table describes the data elements included in the Lot folder.
Table 3-7 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 3-8 Data elements in the shipment folder
| Data elements | Description |
|---|---|
|
ORDER_TYPE |
Indicates how a shipment was initiated:
|
|
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. |
|
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:
|
|
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 3-9 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:
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. |
|
TRIAL_SUPPLY_TYPE |
Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed:
|
|
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 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. |
| COUNT_OF_KITS | The total count of kits. |
| IS_NON_SERIALIZED_KIT | Indicates if the kit is non serialized:
|
Parent topic: Blinded Kits dataset
Audit folder
This table describes the data elements included in the Audit folder.
Table 3-10 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:
|
| 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:
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:
|
| 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: Blinded Kits dataset
Reference folder
This table describes the data elements in the Reference folder.
Table 3-11 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. |
|
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 increases incrementally every time a data point is modified. |
|
DH_TIMESTAMP |
A timestamp that indicates when the data became available in the dataset. |
|
INVENTORY_WID |
Indicates the numeric identifier of the study's inventory. |
|
SHIPMENT_RECEIVED_BY_WID |
Indicates the numeric identifier of the user who registered the shipment. For more information, see Register a shipment. |
|
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. |
|
COUNT |
Represents the count of records in the dataset. |
Parent topic: Blinded Kits dataset