Subject dataset
You can use the Subject dataset to analyze and visualize customized subject data in Oracle Clinical One Analytics.
Modes
Available in all 3 modes: Testing, Training, and Production
What type of data can I include in a custom report or visualization on subject data?
With this dataset, you can find information such as:
- The number of subjects that have been screened at a specific site
- All subjects over 60 that have been screened failed
- All the reasons why subjects have failed screening at a specific site
- The number of subjects that have been randomized in a selected country
For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.
Note:
Blank columns in Oracle Clinical One Analytics indicatenull
or not applicable.
Tip:
In order for Oracle Clinical One Analytics to perform optimally, begin by adding data elements from the Required folder to your workbook. For more information, see Create and edit a data visualization.- Study folder
- Site folder
- Country folder
- Subject (Required) folder
- Event folder
- Audit folder
- Aggregation
- Reference folder
Parent topic: Dataset descriptions
Study folder
This table describes the data elements included in the Study folder
Table 2-43 Data elements in the Study folder
Data element | Description |
---|---|
STUDY_MODE | Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. |
STUDY_ID_NAME | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
STUDY_TITLE | A protocol's title as specified by the study manager. |
STUDY_REFNAME | The STUDY_ID_NAME data element that is converted to uppercase and spaces are removed. This value never changes after created even if STUDY_ID_NAME changes. |
STUDY_PHASE | A study's phase as indicated by the study manager when they created the study. |
THERAPEUTIC_AREA | Indicates the therapeutic area as specified by the study manager when they created the study. |
BLINDING_TYPE | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. |
STUDY_VERSION | Indicates the study version number of the referencing data in a custom report. |
STUDY_SERIAL_NUMBER |
For internal use only. Internal Clinical One study identifier. |
Parent topic: Subject dataset
Site folder
This table describes the data elements included in the Site folder.
Note:
Only a site's primary address is transmitted to Oracle Clinical One Analytics.Table 2-44 Data elements in the site folder
Data element | Description |
---|---|
ADD_SUBJECTS | Flag that enables or prevents site users from adding subjects at one or multiple sites. |
ADDRESS_CITY | A site's city as entered by the site manager when they created or last modified the site. |
ADDRESS_COUNTRY | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
ADDRESS_POSTALCODE | The Zip Postal Code associated with a site's address. |
ADDRESS_STATE_OR_PROV_OR_CNTY | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
ADDRESS_STREET_1 | A site's first address as entered by the site manager when they created or last modified the site. |
ADDRESS_STREET_2 | A site's second address as entered by the site manager when they created or last modified the site. |
DEA_NUMBER | The DEA registration number. |
DISPENSE_TO_SUBJECTS | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. |
DRUG_DESTRUCTION_CAPABLE | Flag that defines if the kit type is destructible at the site. |
Email address of the site as entered by the site administrator when they created or last modified the site. | |
EXPIRATION | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
FAX | The contact fax number as entered by the site administrator when they created or last modified the site. |
INITIAL_SUBJECTS_COUNT | Number of initial subjects included in the SDV strategy. |
INITIAL_SUBJECTS_SDV_TYPE | Type of Source Data Verification: All Questions or Critical Questions. |
PHONE | The contact phone number as entered by the site manager when they created or last modified the site. |
PI_PREFIX | The principal investigator's prefix at the site. |
RANDOMIZE_SUBJECTS | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. |
REMAINING_SUBJECTS_PERCENTAGE | Number of remaining subjects included in the SDV strategy. |
REMAINING_SUBJECTS_SDV_TYPE | Type of Source Data Verification: All Questions or Critical Questions. |
SCREEN_SUBJECTS | Flag that enables or prevents site users from screening subjects at one or multiple sites. |
SDV_GROUP_NAME | Name of the SDV Strategy, as entered by the study manager. |
SHIPPING_ADDRESS_1 | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
SHIPPING_ADDRESS_2 | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
SHIPPING_ATTENTION | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
SHIPPING_CITY | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
SHIPPING_COUNTRY | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
SHIPPING_EMAIL | Email address associated with the shipping address. |
SHIPPING_FAX | Fax number associated with the shipping address. |
SHIPPING_PHONE | Phone number associated with the shipping address. |
SHIPPING_STATE_OR_PROV_OR_CNTY | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
SHIPPING_ZIP | Zip Postal Code associated with the shipping address. |
SITE_ID_NAME | Indicates the site ID as entered by a site manager when they created or last modified a site. |
SITE_STATUS | Indicates the status of a site whether it is New, Active, or Retired. |
SITE_STUDY_VERSION | The study version assigned to the site, as configured by a site manager. |
TIMEZONE | Indicates the time zone the site is currently placed on as specified by a site manager. |
INVESTIGATOR | A Principal Investigator's Full Name as listed when the site manager created the site. |
SITE_NAME | Indicates the site's name as entered by a site manager when they created or last modified a site. |
SITE_SERIAL_NUMBER | The serial number of the site |
FROM_SITE_NAME | If a subject is transferred, this field is populated with the site the subject was transferred from |
SITE_TYPE | Indicates the type of organization. |
Parent topic: Subject dataset
Country folder
This table describes the data elements included in the Country folder.
Table 2-45 Data elements in the Country folder
Data element | Description |
---|---|
COUNTRY_NAME | Indicates a country's two-digit ISO code. |
Parent topic: Subject dataset
Subject (Required) folder
This table describes data elements in the Subject (Required) folder.
Table 2-46 Data elements in the Subject folder
Data element | Description |
---|---|
OLD_SUBJECT_NUMBER | A subject's previously assigned number in the system for a transferred subject. |
SUBJECT_NUMBER | The number currently assigned to the subject in the system as identifier. |
SCREENING_NUMBER | Always displays the original screening number, assigned to the subject at screening. |
DOB |
Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
SCREENING_DATE | Date of the subject's initial screening visit. |
STATE | A subject's state. |
STATE_DATE | The date the subject entered a state. |
SCREENING_FAILURE | Indicates whether a subject failed the screening. |
ENROLLMENT_FAILURE |
Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
ENROLLMENT_OVERRIDE |
Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
INFORMED_CONSENT_DATE |
The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
GENDER |
The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
CODE_BREAK | Indicates whether a subject went through a Code Break event. |
PREVIOUS_SUBJECT_NUMBER | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
EXTERNAL_SOURCE_STATUS_DATE | Indicates the date on which the subject status was updated by an external source. |
Parent topic: Subject dataset
Event folder
This table describes data elements in the Events folder.
Table 2-47 Data elements in the Event folder
Data element | Description |
---|---|
EVENT_TYPE | Displays the type of event:
|
Parent topic: Subject dataset
Audit folder
This table describes the data elements included in the Audit folder.
Table 2-48 Datat elements in the audit folder
Data element | Description |
---|---|
VERSION_START | Indicates the date and time of when the data was changed. |
VERSION_END | Indicates the date and time of when data was changed, if the data is not current. |
OPERATION_TYPE | Audit trail field that represents the type of operation performed (i.e. create, modify). |
USER_NAME |
Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
OBJECT_VERSION_NUMBER | Audit trail field that represents the version number of the data. |
REASON | Indicates a reason for changes in a subject's data. Populated by drop-down list. |
COMMENTS | Required comment in a reason for change if ‘Other’ is selected. Populated as Rule Execution for calculated values. |
IS_CURRENT | Audit trail field to display either current status or full audit trail of the data. |
CURRENT_STUDY_ROLE_NAME | Specifies of the role of the user who updated the given record. If the user's study role changes, this field will show the current study role of the given user. |
Parent topic: Subject dataset
Aggregation
Note:
If a form contains a hidden and required question that wasn’t answered, the form’s status is considered Incomplete and is not counted in the COMPLETED_FORMS data element, despite its status being displayed as Complete in the Oracle Clinical One Platform.This table describes data elements in the Aggregation folder.
Table 2-49 Data elements in the Aggregation folder
Data element | Description |
---|---|
COMPLETED_FORMS | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
COMPLETED_VISITS | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
TOTAL_FORMS | The total number of forms across visits in the study version.
|
TOTAL_FORMS_COMPLETED_VISITS | The total number of completed forms associated with visits |
TOTAL_VISITS | The total number of visits in a study version. This count does not include unscheduled visits. |
Parent topic: Subject dataset
Reference folder
This table describes data elements in the Reference folder.
Table 2-50 Data elements in the Reference folder
Data element | Description |
---|---|
USER_WID |
Indicates a user's numeric identifier. |
SOFTWARE_VERSION_NUMBER |
A number that represents an incremental increase every time a data point is modified. |
DH_TIMESTAMP |
A timestamp that indicates when the data became available in the dataset. |
FROM_SITE_WID | A number that represents a site's unique identifier from which a subject was transferred. |
SUBJECT_WID |
Indicates a subject's numeric identifier. |
DESCRIPTION | This is a placeholder column that does not contain any data. |
STUDY_WID |
A number that represents the unique identifier of the study. |
SITE_WID |
A number that represents the unique identifier of a site. |
COUNT | Represents the count of subjects. |
CURRENT_STUDY_ROLE_WID |
Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
Parent topic: Subject dataset