[Deprecated]: V1.0

post

/ec-datahub-svc/rest/v1.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits

Deprecated: Use latest version instead.

Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.

The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.

Supports select, filter, sort, limit, and offset query patterns.

The dataset returns rows at inventory level for unblinded kits associated with the study and mode.

Required permission: UnblindedKitsDatasetPost.

Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.

Request

Path Parameters
  • Execution mode for the study.

    Allowed values: test, active, training.

    Example: test.

  • Unique study identifier supplied in the studyId path parameter.

    Use the uppercase hexadecimal UUID value for the study.

    Example: 0C7CBA3F70034C47947E2FAB086BFBF5.

  • Unique tenant identifier supplied in the tenantId path parameter.

    Use the uppercase hexadecimal UUID value for the tenant.

    Example: EC942244BB30163BE053BEC44C64CF34.

Query Parameters
  • Minimum Value: 0

    Page size for the result set.

    • 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.
    • Positive values enable pagination.
    • Negative values return HTTP 400.
  • Minimum Value: 0

    Zero-based row offset.

    • Counts rows, not pages.
    • To fetch the next page, repeat the same request body and set offset = previous offset + previous count.
    • When limit = 0, this value is ignored and the response echoes offset = 0.
    • When limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page.
    • Negative values return HTTP 400.
Supported Media Types
Request Body - application/json ()
Root Schema : schema
Type: object

Submit a structured query for a Data Hub dataset.

  • selectColumns is required and must contain one or more valid column names exposed by the target dataset version.
  • whereColumns is optional and provides structured filter predicates. Supported operators are =, !=, <>, >, >=, <, <=, LIKE, NOT LIKE, IN, NOT IN, BETWEEN, NOT BETWEEN, IS, and IS NOT.

    Default behavior: Data is filtered based on the STUDY_WID column.

  • orderColumns is optional and controls sort order. For stable multi-page retrieval, keep the same orderColumns across page requests.
Show Source
  • orderColumns

    Optional sort instructions to apply to the result set.

    Duplicate order-by columns are rejected.

  • selectColumns

    Required non-empty list of dataset column names to return.

    Column validation is case-insensitive, and the response echoes canonical uppercase dataset column names in the same order.

  • whereColumns

    Optional structured filter predicates.

    This is the request-body equivalent of a WHERE clause.

    All predicate values are supplied as strings and are parsed according to the underlying dataset column type.

Nested Schema : orderColumns
Type: array

Optional sort instructions to apply to the result set.

Duplicate order-by columns are rejected.

Show Source
Example:
[
    {
        "columnName":"VERSION_START",
        "sortOrder":"ASC"
    }
]
Nested Schema : selectColumns
Type: array

Required non-empty list of dataset column names to return.

Column validation is case-insensitive, and the response echoes canonical uppercase dataset column names in the same order.

Show Source
  • Required non-empty list of dataset column names to return.

    Column validation is case-insensitive, and the response echoes canonical uppercase dataset column names in the same order.

    Example: ["STUDY_VERSION","STUDY_ID"]
Example:
[
    "STUDY_VERSION",
    "STUDY_ID"
]
Nested Schema : whereColumns
Type: array

Optional structured filter predicates.

This is the request-body equivalent of a WHERE clause.

All predicate values are supplied as strings and are parsed according to the underlying dataset column type.

Show Source
Example:
[
    {
        "columnName":"STUDY_ID",
        "operator":"=",
        "value":[
            "A86F2D0BB610404DB62D37AFA9C20B50"
        ]
    }
]
Nested Schema : QueryOrder
Type: object

Sort instruction specifying a dataset column and optional order direction.

Show Source
  • Required dataset column name to sort by.

    Column-name validation is case-insensitive.

    Example: VERSION_START
  • Allowed Values: [ "ASC", "DESC" ]

    Optional sort direction.

    If omitted, SQL default ascending order is used for that column. Allowed values are ASC and DESC.

    Example: ASC
Example:
[
    {
        "columnName":"VERSION_START",
        "sortOrder":"ASC"
    }
]
Nested Schema : QueryPredicate
Type: object
Structured filter predicate used to constrain dataset results by column, operator, and value
Show Source
  • Required dataset column name to filter on. Column-name validation is case-insensitive.
    Example: STUDY_ID
  • Allowed Values: [ ">", "<", "=", ">=", "<=", "<>", "!=", "IN", "NOT IN", "BETWEEN", "NOT BETWEEN", "LIKE", "NOT LIKE", "IS", "IS NOT" ]
    Required comparison operator. Use one value for =, !=, <>, >, >=, <, <="," like, and not like; one or more values for in in; exactly two between between; value equal to null is not.< div>
    Example: =
  • value
    Filter values as strings. Value cardinality depends on the operator: one for most operators, one or more for IN/NOT IN, exactly two for BETWEEN/NOT BETWEEN, and exactly one value equal to NULL for IS/IS NOT.
Example:
[
    {
        "columnName":"STUDY_ID",
        "operator":"=",
        "value":[
            "A86F2D0BB610404DB62D37AFA9C20B50"
        ]
    }
]
Nested Schema : value
Type: array
Filter values as strings. Value cardinality depends on the operator: one for most operators, one or more for IN/NOT IN, exactly two for BETWEEN/NOT BETWEEN, and exactly one value equal to NULL for IS/IS NOT.
Show Source
  • Filter values as strings. Value cardinality depends on the operator: one for most operators, one or more for IN/NOT IN, exactly two for BETWEEN/NOT BETWEEN, and exactly one value equal to NULL for IS/IS NOT.
    Example: ["A86F2D0BB610404DB62D37AFA9C20B50"]
Example:
[
    "A86F2D0BB610404DB62D37AFA9C20B50"
]
Examples

Back to Top

Response

Supported Media Types

200 Response

Response behavior

  • The response is tabular. columns defines the selected output order, and each row in data follows that same order.
  • Every value in data is returned as a JSON string or null, including logical numbers and date/time values.
  • hasMore = "true" means more matching rows exist after the current page.
  • If filters match no rows, or offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = "false".

Section index

Study context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers

Study context

Study-level identifiers, version metadata, and protocol attributes associated with the dataset row.

Column Name Data Type Description
STUDY_TITLEVARCHAR2(4000 CHAR)

The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode.

When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset:

  • P_01_A23 (for study version 1.0.2)
  • P01_A23_Production2 (for study version 1.0.3)
  • P01_A23_Production3 (for study version 1.0.4)
STUDY_ID_NAMEVARCHAR2(64 CHAR)A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number.
STUDY_REFNAMEVARCHAR2(64 CHAR)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_PHASEVARCHAR2(64 CHAR)A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other.
BLINDING_TYPEVARCHAR2(64 CHAR)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. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational.
THERAPEUTIC_AREAVARCHAR2(64 CHAR)Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines.

Parent topic: Section index


Site context

Site profile, operational settings, and site-maintained contact details associated with the dataset row.

Column Name Data Type Description
SITE_NAMEVARCHAR2(500 CHAR)Indicates the site's name as entered by a site manager when they created or last modified a site.
SITE_ID_NAMEVARCHAR2(50 CHAR)Indicates the site ID as entered by a site manager when they created or last modified a site.
SITE_STATUSVARCHAR2(50 CHAR)Indicates the status of a site whether it is New, Active, or Retired.
SITE_TYPEVARCHAR2(50 CHAR)Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other.
SITE_STUDY_VERSIONVARCHAR2(2048 CHAR)The study version assigned to the site, as configured by a site manager.
INVESTIGATORVARCHAR2(2048 CHAR)A Principal Investigator's Full Name as listed when the site manager created the site.
PI_PREFIXVARCHAR2(2048 CHAR)The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister.
DEA_NUMBERVARCHAR2(2048 CHAR)The DEA registration number.
EXPIRATIONVARCHAR2(2048 CHAR)Indicates the expiration date of the DEA Registration Number as defined by a site manager.
ADD_SUBJECTSVARCHAR2(2048 CHAR)Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false.
SCREEN_SUBJECTSVARCHAR2(2048 CHAR)Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false.
RANDOMIZE_SUBJECTSVARCHAR2(2048 CHAR)Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false.
DISPENSE_TO_SUBJECTSVARCHAR2(2048 CHAR)Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false.
DRUG_DESTRUCTION_CAPABLEVARCHAR2(2048 CHAR)Flag that defines if the kit type is destructible at the site. Possible values include true or false.
SDV_GROUP_NAMEVARCHAR2(255)Name of the SDV Strategy, as entered by the study manager.
INITIAL_SUBJECTS_COUNTVARCHAR2(2048)Number of initial subjects included in the SDV strategy.
INITIAL_SUBJECTS_SDV_TYPEVARCHAR2(2048)Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only.
REMAINING_SUBJECTS_PERCENTAGEVARCHAR2(2048)Number of remaining subjects included in the SDV strategy.
REMAINING_SUBJECTS_SDV_TYPEVARCHAR2(2048)Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only.
ADDRESS_STREET_1VARCHAR2(150 CHAR)A site's first address as entered by the site manager when they created or last modified the site.
ADDRESS_STREET_2VARCHAR2(150 CHAR)A site's second address as entered by the site manager when they created or last modified the site.
ADDRESS_CITYVARCHAR2(100 CHAR)A site's city as entered by the site manager when they created or last modified the site.
ADDRESS_STATE_OR_PROV_OR_CNTYVARCHAR2(100 CHAR)A site's state, province, or county as entered by the site manager when they created or last modified the site.
ADDRESS_POSTALCODEVARCHAR2(20 CHAR)The Zip Postal Code associated with a site's address.
ADDRESS_COUNTRYVARCHAR2(4000 CHAR)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.
PHONEVARCHAR2(500 CHAR)The contact phone number as entered by the site manager when they created or last modified the site.
FAXVARCHAR2(500 CHAR)The contact fax number as entered by the site administrator when they created or last modified the site.
EMAILVARCHAR2(500 CHAR)Email address of the site as entered by the site administrator when they created or last modified the site.
TIMEZONEVARCHAR2(2048 CHAR)Indicates the time zone the site is currently placed on as specified by a site manager.
SHIPPING_ATTENTIONVARCHAR2(2048 CHAR)Indicates the name of the person who will receive shipments at the site, as specified by a site manager.
SHIPPING_ADDRESS_1VARCHAR2(150 CHAR)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_2VARCHAR2(150 CHAR)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_CITYVARCHAR2(100 CHAR)City associated with the shipping address, as entered by the site manager when they created or last modified the site.
SHIPPING_STATE_OR_PROV_OR_CNTYVARCHAR2(100 CHAR)State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site.
SHIPPING_ZIPVARCHAR2(20 CHAR)Zip Postal Code associated with the shipping address.
SHIPPING_COUNTRYVARCHAR2(4000 CHAR)Country associated with the shipping address, as entered by the site manager when they created or last modified the site.
SHIPPING_PHONEVARCHAR2(500 CHAR)Phone number associated with the shipping address.
SHIPPING_FAXVARCHAR2(500 CHAR)Fax number associated with the shipping address.
SHIPPING_EMAILVARCHAR2(500 CHAR)Email address associated with the shipping address.

Parent topic: Section index


Country context

Country-level fields exposed separately in Oracle Analytics for geographic reporting.

Column Name Data Type Description
COUNTRY_NAMEVARCHAR2(4000 CHAR)Indicates a country's two-digit ISO code.

Parent topic: Section index


Subject context

Subject identity, status, enrollment, and transfer attributes associated with the record.

Column Name Data Type Description
SUBJECT_NUMBERVARCHAR2(500 CHAR)

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_STATEVARCHAR2(100 CHAR)

A subject's state in Clinical One Cloud Service.

Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete.

Parent topic: Section index


Event context

Visit metadata, scheduling rules, and visit-status attributes associated with the dataset row.

Column Name Data Type Description
EVENT_TITLEVARCHAR2(64 CHAR)The event's title, defined by the user when an event is created.
EVENT_ID_NAMEVARCHAR2(16 CHAR)The event's id as in Clinical One Cloud Service.
EVENT_REFNAMEVARCHAR2(64 CHAR)

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_TYPEVARCHAR2(100)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. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed.
VISIT_TYPEVARCHAR2(100 CHAR)Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent.
VISIT_STATUSVARCHAR2(32 CHAR)

Indicates a visit's status in the system. Can have one of the following values:

  • NEW: the visit was dynamically triggered 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.
  • INPROGRESS: the visit was never completed and has one or more required items with no saved data.
  • INCOMPLETE: 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.
  • COMPLETE: all required items within the visit are completed and there are no open queries.
  • COMPLETE_ERR: all required items within the visit are completed but there are open queries.
  • 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_ORDERNUMBERThe order in which subject visits occur, as configured in the study design.
VISIT_IS_REQUIREDCHAR(1)Indicates if a visit is required. Possible values include 0 or 1.
IS_SCHEDULED_VISITCHAR(1)Indicates if the visit is scheduled. Possible values include Y or N.
SCHEDULED_FROM_EVENT_NAMEVARCHAR2(64 CHAR)

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_START_DATEDATEDate stamp of a visit's start date.
PROJECTED_VISIT_START_DATETIMESTAMP(6)Date when the next scheduled visit should start in the study, based on the configured visit schedule.
PROJECTED_VISIT_END_DATETIMESTAMP(6)Date when the next scheduled visit should end in the study, based on the configured visit schedule.
PROJECTED_VISIT_DATETIMESTAMP(6)Date when the next scheduled visit should take place in the study, based on the configured visit schedule.
DELAY_DAYSNUMBERThe number of days between the prior scheduled visit.
DELAY_HOURSNUMBERThe number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field).
VISIT_WINDOW_BEFORE_DAYSNUMBERIndicates how many days before the scheduled date and time the visit can occur, as entered by a study designer.
VISIT_WINDOW_BEFORE_HOURSNUMBERIndicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer.
VISIT_WINDOW_AFTER_DAYSNUMBERIndicates how many days after the scheduled date and time the visit can occur.
VISIT_WINDOW_AFTER_HOURSNUMBERIndicates how many hours after the scheduled date and time the visit can occur.

Parent topic: Section index


Randomization context

Randomization, cohort, treatment-arm, and allocation settings associated with the dataset row.

Column Name Data Type Description
RANDOMIZATION_TITLEVARCHAR2(64 CHAR)Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service.
RANDOMIZATION_DESCRIPTIONVARCHAR2(4000 CHAR)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_TYPEVARCHAR2(32 CHAR)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_NAMEVARCHAR2(64 CHAR)Indicates the name of the cohort as defined by the study designer when creating a randomization design.
TREATMENT_ARM_TITLEVARCHAR2(64 CHAR)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_DESCRIPTIONVARCHAR2(4000 CHAR)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_IDVARCHAR2(64 CHAR)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.
RAND_NUMBERNUMBER

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_STATUSVARCHAR2(64 CHAR)

Indicates the randomization status for the subject's randomization number. Can have one of the following values:

  • Assigned: the subject has a randomization number assigned.
  • Randomized in error: the subject was randomized in error.
RANDOMIZATION_DATETIMESTAMP(6)Indicates the date on which a subject has been randomized in the study.
RERANDOMIZATIONNUMBERIndicates 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.
RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPESNUMBER

Indicates the option that a study designer chose (1 or 0) when configuring this setting.

  • 1: 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.
  • 0: 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_NUMBERSNUMBER

Indicates the option that a study designer chose (1 or 0) when configuring this setting.

  • 1: 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.
  • 0: Indicates that skipped randomization numbers are never assigned to subjects.

Parent topic: Section index


Lot context

Lot identifiers, expiration controls, and supply-state attributes associated with the row.

Column Name Data Type Description
BLINDED_LOT_TITLEVARCHAR2(64 CHAR)Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot.
BLINDED_LOT_SHORT_NAMEVARCHAR2(64 CHAR)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_EXPIRATION_DATEDATEIndicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot.
BLINDED_LOT_DO_NOT_COUNT_DAYSNUMBERIndicates 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_DAYSNUMBERIndicates 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.
MANFACTURING_LOT_TITLEVARCHAR2(64 CHAR)Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot.
MANFACTURING_LOT_SHORT_NAMEVARCHAR2(64 CHAR)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_EXPIRATION_DATEDATEIndicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot.
MANFACTURING_LOT_DO_NOT_COUNT_DAYSNUMBERIndicates 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_DAYSNUMBERIndicates 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.

Parent topic: Section index


Shipment context

Shipment lifecycle, receipt, and tracking details associated with kit distribution.

Column Name Data Type Description
SHIPMENT_NAMEVARCHAR2(64 CHAR)Indicates a shipment's full name.
SHIPMENT_STATUSVARCHAR2(64 CHAR)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 Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED.
TRACKING_NUMBERVARCHAR2(64 CHAR)Indicates a shipment's tracking number, as specified by the depot user.
SHIPMENT_CREATED_DATETIMESTAMP(6)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_DATETIMESTAMP(6)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.

Parent topic: Section index


Kits context

Inventory, dispensing, dosing, and verification fields associated with the kit or subject record.

Column Name Data Type Description
KIT_NUMBERNUMBERIndicates a kit's number, as assigned in the system.
BAR_CODEVARCHAR2(1000 CHAR)If included in a study, this indicates a kit's bar code as generated by the system.
SEQUENCE_NUMBERNUMBERIndicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence.
KIT_DESCRIPTIONVARCHAR2(4000 CHAR)Indicates a kit's description, as specified by the study designer when they created the kit type.
KIT_TYPEVARCHAR2(255 CHAR)

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
KIT_TYPE_IDVARCHAR2(64 CHAR)Indicates the unique identifier for a kit type.
KIT_STATUSVARCHAR2(64 CHAR)

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?

INSTANCE_NUMBERNUMBERIndicates the repeat instance number of the visit.
DOSAGENUMBERIndicates the dosage for the dispensed kit, when the kit contains calculated doses.
FREQUENCYVARCHAR2(64 CHAR)Indicates the dosing frequency as defined by a study designer.
MEASUREMENTVARCHAR2(1000 CHAR)Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer.
TRIAL_SUPPLY_TYPEVARCHAR2(16 CHAR)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
TITRATIONNUMBERIndicates if a kit type is part of a kit type titration. Values can be 1 or 0.
MINIMUM_KITS_TO_SHIPNUMBERIndicates 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.
QUANTITYNUMBERIndicates a kit's quantity, as specified by the study designer.
UNITS_PER_KITNUMBER

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_VALUENUMBER(20,2)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.
SINGLE_UNIT_DOSE_UNITSVARCHAR2(16 CHAR)Indicates how one unit in the kit is measured. For example: g, mg, ml, etc.
BALANCE_UNITSNUMBERIndicates the total units of a kit minus the missing and returned units.
RETURNED_UNITSNUMBERNumber of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA)
MISSING_UNITSNUMBERNumber of lost or damaged units in the kit as indicated by the site user.
CALCULATING_DOSESNUMBERIndicates 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.
CONSERVEDVARCHAR2(16 CHAR)Indicates whether a kit was conserved by a site user. Possible values include true or false.
DEVICE_TYPEVARCHAR2(255)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_CONNECTIONVARCHAR2(255)

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
DISTRIBUTION_SETTINGSVARCHAR2(16 CHAR)

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.
CRA_VERIFIEDNUMBERIndicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA).
DISPENSATION_DATETIMESTAMP(6)Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject.
DISPENSATION_CONFIRMEDNUMBERIndicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1.
CONFIRMED_DATETIMESTAMP(6)Indicates the date at which a specified kit's dispensation was confirmed.
CONFIRMED_BYVARCHAR2(255 CHAR)Indicates the email address of the user who confirmed the dispensation of a specified kit.
VERIFIED_DATETIMESTAMP(6)Indicates the date when inventory was verified. Date is displayed in UTC.
VERIFIED_BYVARCHAR2(255 CHAR)Indicates the user who verified inventory data.

Parent topic: Section index


Calculated dose context

Calculated-dose configuration and measured values associated with dose determination for the dispensed kit.

Column Name Data Type Description
CALCULATED_DOSE_TITLEVARCHAR2(64 CHAR)Indicates the title of the kit type containing calculated doses, as specified by the study designer.
FORM_QUESTION_FOR_CALCULATED_DOSEVARCHAR2(64 CHAR)Indicates the question that is selected by the study designer to be used in calculating the appropriate dose.
VISIT_WHERE_FORM_IS_COLLECTEDVARCHAR2(64 CHAR)Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer.
SUBJECT_MEASUREMENTNUMBER(20,2)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.
KIT_MEASUREMENTNUMBER(20,2)Indicates the total numeric value for the product in the kit, as specified by the study designer.
DOSE_FREQUENCYVARCHAR2(21 CHAR)Indicates how many doses the subject must consume, as specified by the study designer.
DOSE_PRECISIONNUMBERIndicates 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_UPNUMBERIndicates 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_UNITSNUMBERIndicates 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: Section index


Audit context

Audit-trail metadata describing row versioning, acting users, and reason-for-change details.

Column Name Data Type Description
VERSION_STARTTIMESTAMP(6)Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version.
VERSION_ENDTIMESTAMP(6)Indicates the date and time of when data was changed, if the data is not current.
OPERATION_TYPEVARCHAR2(16 CHAR)

Audit trail field that indicates how the dataset row version was produced.

  • CREATED: the row was initially created.
  • MODIFIED: an existing row was updated.
  • REMOVED: the row was removed from the active record set.
USER_NAMEVARCHAR2(255 CHAR)

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.

OBJECT_VERSION_NUMBERNUMBERAudit trail field that represents the version number of the data.
REASONVARCHAR2(255 CHAR)Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update.
COMMENTVARCHAR2(2048 CHAR)Required comment captured when "Other" is chosen as the change reason; rule-executed values also populate this field.
IS_CURRENTCHAR(1)Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N).

Parent topic: Section index


Reference and system identifiers

System identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.

Column Name Data Type Description
STUDY_IDRAW(16 BYTE)GUID of the study.
STUDY_WIDNUMBER(10)A number that represents the unique identifier of the study.
SITE_IDRAW(16 BYTE)GUID of the site.
SITE_WIDNUMBER(10)A number that represents the unique identifier of a site.
SUBJECT_IDRAW(16 BYTE)GUID of the subject.
SUBJECT_WIDNUMBER(10)A number that represents the unique identifier of the subject.
TREATMENT_IDRAW(16 BYTE)GUID of the treatment assigned to the subject.
TREATMENT_WIDNUMBER(10)Numeric identifier of the treatment.
EVENT_IDRAW(16 BYTE)GUID of the visit event.
EVENT_WIDNUMBER(10)A number that represents the unique identifier of the event.
CALCULATED_DOSE_IDRAW(16 BYTE)GUID of the calculated dose configuration.
CALCULATED_DOSE_WIDNUMBER(10)Numeric identifier of the calculated dose configuration.
USER_IDRAW(16 BYTE)GUID of the user.
USER_WIDNUMBER(10)Indicates a user's numeric identifier.
VERIFIED_BY_IDRAW(16 BYTE)GUID of the user who verified the kit.
VERIFIED_BY_WIDNUMBER(10)Numeric identifier of the verifying user.
CONFIRMED_BY_IDRAW(16 BYTE)GUID of the user who confirmed the kit dispensation.
CONFIRMED_BY_WIDNUMBER(10)Numeric identifier of the confirming user.
COHORT_IDRAW(16 BYTE)GUID of the cohort assigned to the subject.
COHORT_WIDNUMBER(10)A number that represents the unique identifier of the cohort.
SHIPMENT_IDRAW(16 BYTE)GUID of the shipment.
SHIPMENT_WIDNUMBER(10)Numeric identifier of the shipment.
KIT_DESIGN_IDRAW(16 BYTE)GUID of the kit design.
KIT_DESIGN_WIDNUMBER(10)Numeric identifier of the kit design.
INVENTORY_IDRAW(16 BYTE)GUID of the inventory record.
INVENTORY_WIDNUMBER(10)Numeric identifier of the inventory record.
DH_TIMESTAMPTIMESTAMP(6)A timestamp that indicates when the data became available in the dataset.
SOFTWARE_VERSION_NUMBERNUMBERA number that increases incrementally every time a data point is modified.

Parent topic: Section index


Body ()
Root Schema : DataHubReportDto
Type: object

Tabular dataset response for a dynamic Data Hub query.

columns defines the selected output order, and each row in data aligns positionally to that list.

Show Source
  • columns

    Ordered dataset column names selected by the client.

    Each row in data uses this exact order.

  • Number of rows returned in the current page.

    Example: 2
  • data

    Row data aligned positionally with columns.

    Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.

  • String pagination flag ("true" or "false") indicating whether more matching rows exist after the current page.

    Returned as a string for backward compatibility.

    Example: false
  • Requested page size.

    Dataset endpoints commonly use 0 to mean unpaginated or all rows.

    Example: 100
  • Zero-based row offset applied to the result set.

    Dataset endpoints that disable pagination with limit = 0 typically echo offset = 0 in the response.

    Example: 0
  • Total number of matching rows across all pages after filters are applied.

    This can be non-zero even when the current page is empty because the requested offset is beyond the last row.

    Example: 2
Nested Schema : columns
Type: array

Ordered dataset column names selected by the client.

Each row in data uses this exact order.

Show Source
  • Ordered dataset column names selected by the client.

    Each row in data uses this exact order.

    Example: ["STUDY_ID","RECORD_ID","STATUS"]
Example:
[
    "STUDY_ID",
    "RECORD_ID",
    "STATUS"
]
Nested Schema : data
Type: array

Row data aligned positionally with columns.

Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.

Show Source
  • items

    Row data aligned positionally with columns.

    Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.

Example:
[
    [
        "A86F2D0BB610404DB62D37AFA9C20B50",
        "REC001",
        "Active"
    ],
    [
        "A86F2D0BB610404DB62D37AFA9C20B50",
        "REC002",
        "Inactive"
    ]
]
Nested Schema : items
Type: array

Row data aligned positionally with columns.

Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.

Show Source
  • Row data aligned positionally with columns.

    Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.

    Example: [["A86F2D0BB610404DB62D37AFA9C20B50","REC001","Active"],["A86F2D0BB610404DB62D37AFA9C20B50","REC002","Inactive"]]
Example:
[
    [
        "A86F2D0BB610404DB62D37AFA9C20B50",
        "REC001",
        "Active"
    ],
    [
        "A86F2D0BB610404DB62D37AFA9C20B50",
        "REC002",
        "Inactive"
    ]
]
Examples

400 Response

Returned when the request is invalid.

  • Causes include invalid tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values.
  • Error payload format: {"status":"failed","result":null,"errorData":{"errorCode":"...","errorMessage":"...","details":{...}},"version":1}.
Body ()
Root Schema : DataHubResponse
Type: object

Standard Data Hub response envelope.

Successful responses return status as "success" and populate result. Failed responses return status as "failed" and populate errorData.

Show Source
Nested Schema : errorData
Type: object

Machine-readable error payload when status is "failed".

This field is null when status is "success".

Example:
{
    "errorCode":"VALIDATION_ERROR",
    "errorMessage":"Invalid column name specified in the select columns: SITE_ID1",
    "details":{
        "field":"selectColumns"
    }
}
Nested Schema : result
Type: object

Payload returned by the API when status is "success".

This field is null when status is "failed".

Example:
{
    "message":"Operation succeeded"
}
Examples

401 Response

Returned when the request cannot be authenticated.

The response body is empty.

403 Response

Returned when the request is authenticated but the caller is not authorized to access the requested resource.

The response body contains a plain-text authorization message.

Possible response bodies:

  • Either the resource does not exist, or the user cannot access the resource.
  • The entity is in maintenance mode, or the user cannot access the resource.
Body ()
Root Schema : schema
Type: string

500 Response

Returned when an unexpected server-side error occurs while processing the request.

The response body contains the platform error payload with the error code and description.

Body ()
Root Schema : Status
Type: object
Show Source
Examples

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