V9.0

post

/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/dataCollection

Retrieves the study-permissioned Study Design dataset for a single study and mode.

The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.

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

The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.

This version additionally includes the following data points: SDV_VISIT_START, CODELIST_LINK_TYPE, and CODELIST_LANG.

Required permission: DataCollectionDesignDatasetPost.

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, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.

Request

Path Parameters
  • 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.
    Example:
    100
  • 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.
    Example:
    0
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 | Branch context | Event context | Form context | Item 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_VERSIONVARCHAR2(32 CHAR)Indicates the study version number of the referencing data in a custom report.
VERSION_TITLEVARCHAR2(64 CHAR)

Indicates the title of the study version.

If a value has not been specified for this element, its value displays as NULL.

STUDY_DESIGN_STATUSVARCHAR2(16 CHAR)Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT.
IS_APPROVEDCHAR(1)

This element aides in reviewing Archived study versions that may have been in the Active container in the past. It is applicable to all study versions, and is labeled as:

  • N for any Study Version that was never moved to Active mode.
  • Y for study versions moved from Test to Active. Also applicable when those versions are subsequently moved to archive.
REASON_FOR_REVISIONVARCHAR2(32 CHAR)Indicates the user provided reason for revising the study version. This reason is provided when moving a study version from Test to Active container. If a value has not been specified for this element, its value displays as NULL. Possible values include INITIAL, PROTOCOL_AMENDMENT, REVISION, or VERSION.
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.
REQ_SCREENINGCHAR(1)Indicates if the question is required for screening. Possible values include Y or N.
REQ_RANDOMIZECHAR(1)Indicates if the question is required for randomization. Possible values include Y or N.
REQ_DISPENSECHAR(1)Indicates if the question is required for dispensation. Possible values include Y or N.
OCC_ENABLEDCHAR(1)

Indicates if a study is currently enabled for Electronic Health Record (EHR) data import.

No is displayed if EHR has never been enabled for a study or if a study was disabled for EHR. Possible values include Y or N.

SAFETY_INTEGRATION_ENABLEDCHAR(1)Indicates if the Clinical One Cloud Service to Safety integration is enabled for the study. Possible values include Y or N.

Parent topic: Section index


Branch context

Branching and assignment rules that determine subject flow through the study design.

Column Name Data Type Description
BRANCH_TITLEVARCHAR2(64 CHAR)Indicates the branch title or name.
BRANCH_REFNAMEVARCHAR2(64 CHAR)Indicates the branch reference name used by the system.
BRANCH_VISITVARCHAR2(64 CHAR)Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_FORMVARCHAR2(64 CHAR)Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_QUESTIONVARCHAR2(4000 CHAR)Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_ANSWERVARCHAR2(4000 CHAR)Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question.
BRANCH_ARMVARCHAR2(32767 CHAR)Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm.
IS_CYCLE_BRANCHCHAR(1)States whether the branch is cycled. Possible values include Y or N.
CYCLE_COUNTNUMBERSpecifies the number of cycles in case the branch is cycled.
ASSIGN_SUBJECT_USING_FORM_QUESTIONCHAR(1)Indicates if subjects get assigned to branch by a form question. Possible values include Y or N.
ASSIGN_SUBJECT_USING_TREATMENT_ARMCHAR(1)Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N.

Parent topic: Section index


Event context

Event metadata, visit scheduling, 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(32)

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.
VISIT_TYPEVARCHAR2(32 CHAR)Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent.
VISIT_ORDERNUMBER

An integer indicating a visit's ordinal position (order) within the visit schedule for the selected study version. These values may change across versions; for example, a visit that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new visit is inserted at position 3.

Note: Ordinal values are study design attributes only and do not reflect a subject's progress through a study or carry clinical significance.

About draft study versions: VISIT_ORDER values won't appear in the dataset for a draft study version until you either move the draft to the test container or choose Send to Analytics from the draft container menu.

About visits: The dataset output displays scheduled (non-branch and branch) visits and unscheduled visits in the following manner.

  • Scheduled non-branch visits (for example, a screening visit) are listed first, followed by scheduled branch visits, and finally unscheduled visits when the VISIT_ORDER is sorted in ascending order.
  • Scheduled branch visits are assigned an ordinal value that reflects their position in a branch. When sorted in ascending order, visits from earlier tiers appear before those in later ones.

Note: A tier, the highest level in visit branch design, is used to organize parallel branches, also called arms or cohorts. Each branch consists of a group of visits.

For instance, a study includes two tiers (Tier1 and Tier2); each consists of two branches (BranchA and BranchB), and each branch contains a set of visits (Day1 and Day15). When sorted in ascending order, they appear as follows in the output.

  • Tier1.BranchA.Day1
  • Tier1.BranchA.Day15
  • Tier1.BranchB.Day1
  • Tier1.BranchB.Day15
  • Tier2.BranchA.Day1
  • Tier2.BranchA.Day15
  • Tier2.BranchB.Day1
  • Tier2.BranchB.Day15
  • Unscheduled visits, which include Withdrawal, Screen Fail, Rescreen, and Study Completion visits, are assigned an ordinal value based on the sequence defined on the Unscheduled Visit or Event sidebar and appear after scheduled branch visits when VISIT_ORDER is sorted in ascending order.
VISIT_CREATION_ORDERNUMBERIndicates the order number the event was created in relation to when the study started.
VISIT_HOUR_SEQ_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 Y or N.
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.

SCHEDULED_FROM_EVENT_REFNAMEVARCHAR2(64 CHAR)

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..

EARLIEST_VISIT_TO_COMPLETEVARCHAR2(64 CHAR)

When creating a study completion visit, you can specify an earlier visit that must be completed in order to enable the option for marking the subject as Complete. The reference name of that specified scheduled visit is provided in this field.

This data element is added for each event. However, it is only specified when the record is for a Subject Completion event, while all other records display as a NULL value.

SDV_VISIT_STARTVARCHAR2(12)

This data element captures SDV settings for visit dates with the following possible values:

  • NULL
  • ALL SUBJECTS
  • TARGETED SDV
Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED.
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.
ALERT_OUTSIDE_VISIT_WINDOWVARCHAR2(16 CHAR)

Indicates if there is any rule set to alert if visit date is out of window. Values can be:

  • Off
  • Warning
  • Query

Parent topic: Section index


Form context

Form-level design or collected-form attributes associated with the dataset row.

Column Name Data Type Description
FORM_NAMEVARCHAR2(64 CHAR)The name of the form, as specified by the study designer.
FORM_REFNAMEVARCHAR2(64 CHAR)A form's reference name.
FORM_TYPEVARCHAR2(14)

Indicates the type of form:

  • One-section form
  • Two-section form
  • Lab form
FORM_ORDERNUMBER

An integer indicating a form's ordinal position (order) within a visit for the selected study version. These values may change across versions; for example, a form that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new form is inserted at position 3.

Note: Ordinal values are positive integers that indicate the sequence of forms in a visit as defined by the study design. They do not indicate if a form was started or completed and do not carry any clinical significance.

About Advanced Study Versioning (ASV): Duplicate FORM_ORDER values appear in the output when a new form is added using Advanced Study Versioning (ASV) and the dataset is generated for a previous study version. For example, study version 1.0.0.1 includes three forms, and study version 1.0.0.2 introduces a new form (Vitals). The output appears as follows when the dataset is generated for version 1.0.0.1.

However, if the dataset is generated for version 1.0.0.2, no duplicate values appear and the order is sequentially correct.

FORM_IS_REPEATINGCHAR(1)Indicates whether the form is repeating. Possible values include Y or N.
ALLOW_MULTIPLE_INSTANCESNUMBERIndicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1.
ALLOW_ADDITIONAL_ROWSCHAR(1)Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N.
FORM_IS_ROLLOVERCHAR(1)Indicates whether the form is rollover. Possible values include Y or N.
SOURCE_STUDY_NAMEVARCHAR2(64 CHAR)If it is a copied form, indicates the name of the study it was copied from.
SOURCE_STUDY_VERSIONVARCHAR2(32 CHAR)If it is a copied form, indicates the study version of the study it was copied from.
SOURCE_DATAVIEW_NAMEVARCHAR2(64 CHAR)If it is a copied form, indicates the original form it was copied from.
SOURCE_VERSION_STARTTIMESTAMP(6)If it is a copied form, indicates the date and time of when the copied data was entered.
RULE_COPY_STATUSNUMBERIf it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1.

Parent topic: Section index


Item context

Question-level configuration and collected item attributes associated with the dataset row.

Column Name Data Type Description
ITEM_NAMEVARCHAR2(4000 CHAR)Indicates the title of the question, as entered by a study designer.
QUESTION_TYPEVARCHAR2(32 CHAR)

Indicates the type of question as defined by a study designer. For example:

  • Text
  • Number
  • Age
  • Date/time
  • Drop-down
  • Radio buttons
  • Checkboxes
DATA_TYPEVARCHAR2(64 CHAR)

Indicates the data format of the collected data.

Note: Data type refers to how collected data is stored, which is different from the question type that defines how the question is presented to the site user. Possible values include VARCHAR, NUMBER, or DATE.

FORMATVARCHAR2(40 CHAR)Specifies the answer format. For example an specific date format, or the number of decimals after the point.
QUESTION_HINTVARCHAR2(4000 CHAR)Indicates information that a study designer provided as a hint to help answer a question.
MEASURE_UNITVARCHAR2(64 CHAR)Indicates the measure of unit specified by a study designer for a Number type of question.
ITEM_GROUPVARCHAR2(64 CHAR)If this is a group question, indicates the group question title.
ITEM_GROUP_ORDERNUMBER

Indicates the order of items on two-section forms and in question group type questions.

For example, a study's design includes a question group labeled Scan 1 with two questions: Scan Date and Upload Scan. In the design the group is treated as a single question, so in the output, the ITEM_GROUP and ITEM_ORDER are the same for each question in the group, and ITEM_GROUP_ORDER reflects each question's position within the group.

For any other form or question types, ITEM_GROUP_ORDER is NULL.

ITEM_ORDERNUMBER

A numeric value indicating the ordinal position (order) of a question on a form for the selected study version.

  • Version-specific: ITEM_ORDER reflects the order as defined in that specific study version. Values may change across study versions. For example, a question that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new question is inserted at position 3.
  • Not always an integer: In some study versions, ITEM_ORDER may appear as a decimal value (for example, 2.001 or 4.001). This can occur when new items are inserted into an existing form in a particular study version (for example, items inserted after an existing question and associated with ASV). In these cases, the decimal value indicates the position of the inserted item relative to the prior item without renumbering all subsequent items in that version.
  • Latest version may be re-sequenced: When viewing a later or the latest study version, the same form may show a fully re-sequenced order using consecutive integers (for example, 1, 2, 3, 4, 5, 6).

In a later/latest study version, the order may be displayed as consecutive integers (for example): 1, 2, 3, 4, 5, 6

Note: Ordinal values indicate the sequence of questions on forms as defined by the study design for the selected study version. They do not indicate whether a question was answered and do not carry any clinical significance.

About Age items on forms: When an Age item is added to a form, the system also adds a Date of Birth field and displays them together, making it appear as a single question in the study design. In the study design dataset, however, Age (a calculated item) and Date of Birth are recorded as two distinct items, each on its own row with a unique ordinal value.

GROUP_TYPEVARCHAR2(32 CHAR)Indicates if this is a group question. Possible values include QuestionGroup, section, or table.
SAS_VARIABLEVARCHAR2(32 CHAR)Indicates the SAS Variable of a form defined by a study designer.
SAS_LABELVARCHAR2(4000 CHAR)Indicates the SAS Label of a form defined by a study designer.
REFERENCE_CODEVARCHAR2(64 CHAR)Indicates a question's reference code.
CODE_QUESTIONVARCHAR2(32767 CHAR)

If the question has a Coding Question property, lists the following information:

  • Dictionary
  • Coding Item Type
  • Tag for Central Coding
ITEM_VALUESVARCHAR2(32767)

The raw value of the form question value (can be an array in questions with decodes).

Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible.

For more details see Form item output mapping in data extracts.

CODELIST_VALUESVARCHAR2(32767)

Lists the codelist values added as answers to the current question.

Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible.

CODELIST_LINK_TYPEVARCHAR2(20)

Indicates whether choice questions are DYNAMIC or STATIC.

This value displays as NULL for non-choice questions.

CODELIST_LANGVARCHAR2(5)Indicates the selected language (English, Chinese, Japanese) for the code list values. Possible values include en, zh, or ja.
FORMITEM_IS_REQUIREDCHAR(1)Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N.
READONLYCHAR(1)Indicates that the question is marked as read-only by a study designer. Possible values include Y or N.
ALLOW_FUTURE_DATENUMBER(1)

For Date/Time questions.

Indicates if the user is allowed to enter a future date. Possible values include 0 or 1.

ITEM_DATE_PARTIAL_REQUIREDVARCHAR2(32 CHAR)Indicates the partial date format allowed when partial date entry is enabled for the question.
HIDDENCHAR(1)Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N.
DATA_CLASSIFICATIONVARCHAR2(2048 CHAR)

Indicates how the data is categorized according to its sensitivity and intended use. Applicable only to hidden items.

This data element populates with a comma separated list of all the selected data classification groups of a hidden item. Possible values for this element include:

  • Adjudication data
  • Blinded data
  • PII data
  • Public data
  • Sponsor data
EHR_MAPPINGVARCHAR2(32767 CHAR)Displays the OCC data dictionary mapping value for a question mapped for Electronic Health Record (EHR) data import.
VALIDATION_RULESVARCHAR2(32767)

Specifies the question's validation rule if any. Validation rules types available depend on the type of question:

  • Text questions:
    • Doesn't contain
  • Date/Time and Date of birth questions:
    • After
    • On or After
    • Before
    • On or Before
    • On
    • Not On
    • Not Between
    • Range
  • Number and Age questions:
    • Greater Than
    • Greater Than or Equal To
    • Less Than
    • Less Than or Equal To
    • Is
    • Not Equal To
    • Not Between
    • Range
  • Drop-down and checkboxes questions:
    • Select at Least
    • Select at Most
    • Select Exactly
    • Answer Must Be
  • Radio Buttons questions:
    • Answer Must Be
RULE_ERRORVARCHAR2(32767)Reason for failure if validation status is failed or the rule validation failed.
ACTION_RULESVARCHAR2(32767 CHAR)

Details the action rule of a question which can be of the types:

  • Show Question
  • Show Form
  • Show Visit
  • Link & Show Form
APPLY_CHANGE_VERSIONVARCHAR2(32 CHAR)

Indicates the version in which changes to the form item apply.

This data element refers to the lowest study version in which the change is applied. This means the change is included in all study versions between the APPLY_CHANGE_VERSION and the current study version.

SDVVARCHAR2(12)Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED.

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.
CURRENT_STUDY_ROLE_NAMEVARCHAR2(100 CHAR)Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role.
MODIFIED_BYVARCHAR2(255 CHAR)Indicates the user who last modified the study design record.

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.
EVENT_IDRAW(16 BYTE)GUID of the event.
EVENT_WIDNUMBER(10)A number that represents the unique identifier of the event.
SCHEDULED_FROM_EVENT_IDRAW(16 BYTE)GUID of the event from which the visit was scheduled.
SCHEDULED_FROM_EVENT_WIDNUMBERA number that represents the unique identifier of the parent visit from which the associated visit was scheduled.
FORM_IDRAW(16 BYTE)GUID of the form.
FORM_WIDNUMBERA number that represents the unique identifier of the form.
ITEM_IDRAW(16 BYTE)GUID of the item.
ITEM_WIDNUMBER(10)A number that represents the unique identifier of the item.
MODIFIED_BY_IDRAW(16 BYTE)GUID of the user who modified the study design record.
MODIFIED_BY_WIDNUMBER(10)A number that represents the unique identifier of the user who modified the study.
CURRENT_STUDY_ROLE_IDRAW(16 BYTE)The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user.
CURRENT_STUDY_ROLE_WIDNUMBER(10)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.
BRANCH_IDRAW(16 BYTE)Indicates the branch identifier associated with the row.
BRANCH_WIDNUMBER(10)A number that represents the unique identifier of the visit branch.
SOURCE_DATAVIEW_WIDNUMBERA number that represents the unique identifier of the source form data view in a reference copy rule.
SOURCE_STUDY_WIDNUMBERA number that represents the unique identifier of the source study in a reference copy rule.
ITEM_GROUP_IDNUMBERIndicates the item group ID associated with the question.
DH_TIMESTAMPTIMESTAMP(6)A timestamp that indicates when the data became available in the dataset.

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.

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  • 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.

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  • 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.

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  • 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.

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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
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Examples

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