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.

Browse descriptions of data elements included in this dataset:

• Study folder
  
• Site folder
  
• Country folder
  
• Subject (Required) folder
  
• Event folder
  
• Audit folder
  
• Aggregation
  
• Reference folder
  

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.

Site folder

This table describes the data elements included in the Site folder.

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 or not.
EMAIL	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	A site's first shipping address as entered by the site manager when they created or last modified the site.
SHIPPING_ADDRESS_2	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.

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.

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.
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.

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: Visit_Complete Visit_Started Visit_Date_Changed Visit_Inserted New visits added to the schedule and applied to a study using Advanced Study Versioning (ASV).

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.

Aggregation

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. A repeating form instance is counted as one form. Forms assigned to an unscheduled visit are not included in this count.
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.

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.