V1.0
/ec-datahub-svc/rest/v1.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/safetyCases
Retrieves the study-permissioned Subject Safety Cases dataset for a single study and mode. This dataset applies only to studies integrated with a configured safety system.
The dataset exposes safety case history linked to subjects and sites, including the Clinical One case ID, safety case identifiers, case label, case status, case state, safety comment, submission count, creation timestamp, acceptance timestamp, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns safety case rows for subjects associated with the study and mode.
Required permission: SubjectSafetyCaseDatasetPost.
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, SITE_ID, SUBJECT_ID, and CASE_ID in the orderColumns field of the request payload.
Request
-
mode(required): string
Execution
modefor the study.Allowed values:
test,active,training.Example:
test. -
studyId(required): string(uuid)
Unique study identifier supplied in the
studyIdpath parameter.Use the uppercase hexadecimal UUID value for the study.
Example:
0C7CBA3F70034C47947E2FAB086BFBF5. -
tenantId(required): string(uuid)
Unique tenant identifier supplied in the
tenantIdpath parameter.Use the uppercase hexadecimal UUID value for the tenant.
Example:
EC942244BB30163BE053BEC44C64CF34.
-
limit: integer(int32)
Minimum Value:
0Page size for the result set.
0disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
- Negative values return HTTP 400.
Example:100 -
offset: integer(int32)
Minimum Value:
0Zero-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 echoesoffset = 0. - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. - Negative values return HTTP 400.
Example:0
- application/json
objectSubmit a structured query for a Data Hub dataset.
selectColumnsis required and must contain one or more valid column names exposed by the target dataset version.whereColumnsis optional and provides structured filter predicates. Supported operators are=,!=,<>,>,>=,<,<=,LIKE,NOT LIKE,IN,NOT IN,BETWEEN,NOT BETWEEN,IS, andIS NOT.Default behavior: Data is filtered based on the
STUDY_WIDcolumn.orderColumnsis optional and controls sort order. For stable multi-page retrieval, keep the sameorderColumnsacross page requests.
-
orderColumns: array
orderColumns
Optional sort instructions to apply to the result set.
Duplicate order-by columns are rejected.
-
selectColumns: array
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: array
whereColumns
Optional structured filter predicates.
This is the request-body equivalent of a
WHEREclause.All predicate values are supplied as strings and are parsed according to the underlying dataset column type.
arrayOptional sort instructions to apply to the result set.
Duplicate order-by columns are rejected.
-
Array of:
object QueryOrder
Sort instruction specifying a dataset column and optional order direction.
[
{
"columnName":"VERSION_START",
"sortOrder":"ASC"
}
]arrayRequired 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.
-
Array of:
string
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"]
[
"STUDY_VERSION",
"STUDY_ID"
]arrayOptional 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.
-
Array of:
object QueryPredicate
Structured filter predicate used to constrain dataset results by column, operator, and value
[
{
"columnName":"STUDY_ID",
"operator":"=",
"value":[
"A86F2D0BB610404DB62D37AFA9C20B50"
]
}
]objectSort instruction specifying a dataset column and optional order direction.
-
columnName: string
Required dataset column name to sort by.
Column-name validation is case-insensitive.
Example:VERSION_START -
sortOrder: string
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
[
{
"columnName":"VERSION_START",
"sortOrder":"ASC"
}
]object-
columnName: string
Required dataset column name to filter on. Column-name validation is case-insensitive.Example:
STUDY_ID -
operator: string
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: array
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.
[
{
"columnName":"STUDY_ID",
"operator":"=",
"value":[
"A86F2D0BB610404DB62D37AFA9C20B50"
]
}
]array-
Array of:
string
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"]
[
"A86F2D0BB610404DB62D37AFA9C20B50"
]Response
- application/json
- text/plain
200 Response
Response behavior
- The response is tabular.
columnsdefines the selected output order, and each row indatafollows that same order. - Every value in
datais returned as a JSON string ornull, including logical numbers and date/time values. hasMore = "true"means more matching rows exist after the current page.- If filters match no rows, or
offsetis beyond the last row, the API returns HTTP 200 withdata = [],count = 0, andhasMore = "false".
Section index
Study context | Site context | Country context | Subject context | Safety Case context | Audit context | Reference and system identifiers
Study context
Study-level identifiers, version metadata, and protocol attributes associated with the subject safety case row.
| Column Name | Data Type | Description |
|---|---|---|
STUDY_ID_NAME | VARCHAR2(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_TITLE | VARCHAR2(64 CHAR) | The When you include multiple study versions in your dataset, and each has a different title, the
|
STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
STUDY_PHASE | VARCHAR2(64 CHAR) | Indicates the study phase. Possible values include I, I/II, II, II/III, III, IV, or Other. |
THERAPEUTIC_AREA | VARCHAR2(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. |
BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates the study blinding type. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
Parent topic: Section index
Site context
Site profile, contact, shipping, SDV, and site capability details associated with the subject safety case row.
| Column Name | Data Type | Description |
|---|---|---|
SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
SITE_STATUS | VARCHAR2(32767 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
SITE_TYPE | VARCHAR2(32767 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
SITE_STUDY_VERSION | VARCHAR2(32 CHAR) | The study version assigned to the site, as configured by a site manager. |
TIMEZONE | VARCHAR2(50 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
EHR_ENABLED | VARCHAR2(5 CHAR) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import.
|
ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
ADDRESS_CITY | VARCHAR2(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_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
ADDRESS_COUNTRY | VARCHAR2(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. |
PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
SHIPPING_ADDRESS_1 | VARCHAR2(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_2 | VARCHAR2(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_ATTENTION | VARCHAR2(500 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
SHIPPING_CITY | VARCHAR2(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_CNTY | VARCHAR2(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_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
PI_PREFIX | VARCHAR2(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_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
ADD_SUBJECTS | VARCHAR2(5 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
SCREEN_SUBJECTS | VARCHAR2(5 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
RANDOMIZE_SUBJECTS | VARCHAR2(5 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
DISPENSE_TO_SUBJECTS | VARCHAR2(5 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_CAPABLE | VARCHAR2(5 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
SDV_GROUP_NAME | VARCHAR2(255 CHAR) | Name of the SDV Strategy, as entered by the study manager. |
INITIAL_SUBJECTS_COUNT | VARCHAR2(2048 CHAR) | Number of initial subjects included in the SDV strategy. |
INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048 CHAR) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048 CHAR) | Number of remaining subjects included in the SDV strategy. |
REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048 CHAR) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
Parent topic: Section index
Country context
Country-level fields exposed separately for geographic reporting.
| Column Name | Data Type | Description |
|---|---|---|
COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
Parent topic: Section index
Subject context
Subject identity and state details associated with the safety case row.
| Column Name | Data Type | Description |
|---|---|---|
SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: |
SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is |
Parent topic: Section index
Safety Case context
Safety case identifiers, status, submission, and acceptance details associated with the subject safety case row.
| Column Name | Data Type | Description |
|---|---|---|
CASE_ID | VARCHAR2(32 CHAR) | Clinical One case ID representing the Clinical One case identity. |
SAFETY_CASE_ID | VARCHAR2(4000 CHAR) | Safety case identifier loaded into Clinical One from the configured safety system (ex. Argus). |
CASE_LABEL | VARCHAR2(4000 CHAR) | Safety case label associated with the subject safety case row. Its value depends on the item configured as the safety-case label in the Clinical One study design. |
CASE_STATUS | VARCHAR2(100 CHAR) | Current safety case status displayed consistently with Clinical One UI. Possible values include Not Submitted, Submitted, Transfer Failed, Canceled, Accepted, Rejected, or Dismissed. |
CASE_STATE | VARCHAR2(16 CHAR) | Case state derived from the as-of submitted-row count for the safety case row; blank before first submission. Possible values include INITIAL or FOLLOWUP. |
SUBMISSION_COUNT | NUMBER | Submission count derived from loaded safety case source data. |
CREATION_TIMESTAMP | TIMESTAMP(6) | Source subject safety case record creation timestamp. |
ACCEPTANCE_TIMESTAMP | TIMESTAMP(6) | Timestamp populated only for accepted subject safety case rows. Non-accepted rows return blank. For accepted rows, this is the latest transition into accepted status as of that accepted historical row. |
SAFETY_COMMENT | VARCHAR2(4000 CHAR) | Safety comment captured for the subject safety case. Includes comments integrated from the configured safety system or safety team. |
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_START | TIMESTAMP(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_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced.
|
CURRENT_STUDY_ROLE_NAME | VARCHAR2(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. |
USER_NAME | VARCHAR2(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_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
REASON | VARCHAR2(4000 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
COMMENTS | VARCHAR2(4000 CHAR) | Audit trail comment recorded for the dataset row change. Captures comments specific to case data changes, such as data added to or removed from the case, that are sent to safety. |
IS_CURRENT | CHAR(1 CHAR) | 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 |
|---|---|---|
CASE_WID | NUMBER(10) | A number that represents the unique identifier of the Clinical One case. |
STUDY_ID | RAW(16 BYTE) | GUID of the study. |
STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
SITE_ID | RAW(16 BYTE) | GUID of the site. |
SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
USER_ID | RAW(16 BYTE) | GUID of the user. |
USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
CURRENT_STUDY_ROLE_ID | RAW(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_WID | NUMBER(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. |
DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
SOFTWARE_VERSION_NUMBER | NUMBER | Software version number stored on the subject safety case dataset record. |
Parent topic: Section index
objectTabular dataset response for a dynamic Data Hub query.
columns defines the selected output order, and each row in data aligns positionally to that list.
-
columns: array
columns
Ordered dataset column names selected by the client.
Each row in
datauses this exact order. -
count: integer
(int32)
Number of rows returned in the current page.
Example:2 -
data: array
data
Row data aligned positionally with
columns.Each cell is serialized as a JSON string or
null, even for logical numbers and timestamps. -
hasMore: string
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 -
limit: integer
(int32)
Requested page size.
Dataset endpoints commonly use
0to mean unpaginated or all rows.Example:100 -
offset: integer
(int32)
Zero-based row offset applied to the result set.
Dataset endpoints that disable pagination with
limit = 0typically echooffset = 0in the response.Example:0 -
totalResults: integer
(int32)
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
arrayOrdered dataset column names selected by the client.
Each row in data uses this exact order.
-
Array of:
string
Ordered dataset column names selected by the client.
Each row in
datauses this exact order.Example:["STUDY_ID","RECORD_ID","STATUS"]
[
"STUDY_ID",
"RECORD_ID",
"STATUS"
]arrayRow data aligned positionally with columns.
Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.
-
Array of:
array items
Row data aligned positionally with
columns.Each cell is serialized as a JSON string or
null, even for logical numbers and timestamps.
[
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC001",
"Active"
],
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC002",
"Inactive"
]
]arrayRow data aligned positionally with columns.
Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.
-
Array of:
string
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"]]
[
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC001",
"Active"
],
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC002",
"Inactive"
]
]400 Response
Returned when the request is invalid.
- Causes include invalid
tenantIdorstudyId, negativelimitoroffset, emptyselectColumns, invalid dataset columns, invalidwhereColumnsoperator/value combinations, duplicateorderColumns, invalidsortOrder, and malformed typed filter values. - Error payload format:
{"status":"failed","result":null,"errorData":{"errorCode":"...","errorMessage":"...","details":{...}},"version":1}.
objectStandard Data Hub response envelope.
Successful responses return status as "success" and populate result. Failed responses return status as "failed" and populate errorData.
-
errorData: object
errorData
Machine-readable error payload when
statusis "failed".This field is null when
statusis "success". -
result: object
result
Payload returned by the API when
statusis "success".This field is null when
statusis "failed". -
status: string
Overall request processing status.
Allowed values are "success" and "failed".
Example:success -
version: integer
(int32)
Envelope version number.Example:
1
objectMachine-readable error payload when status is "failed".
This field is null when status is "success".
{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: SITE_ID1",
"details":{
"field":"selectColumns"
}
}objectPayload returned by the API when status is "success".
This field is null when status is "failed".
{
"message":"Operation succeeded"
}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.
string500 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.