Blinded Subject Event dataset

You can use the Blinded Subject Events dataset in Oracle Clinical One Analytics to analyze and visualize blinded data and audit history of events associated to each subject, including randomization and trials supply management (RTSM) related data.

Modes

Available in all 3 modes: Testing, Training, and Production

What type of data can I include in a blinded custom report or visualization on subject events?

With this dataset, you can get custom data such as:

All the week 3 visits for a site that have not been completed
All skipped visits for a subject.
All the subjects that have completed a screening visit in a country
All events that occurred at a site during March
All of the patients that have been randomized in a country in the last 2 weeks
Are my events being completed within the event window?

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:

Note:

Blank columns in Oracle Clinical One Analytics indicate null 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.

Parent topic: Dataset descriptions

Study folder

This table describes the data elements included in the Study folder

Table 2-12 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	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_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.

Parent topic: Blinded Subject Event 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 2-13 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	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_TYPE	Indicates the type of organization.
EHR_ENABLED	Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR.

Parent topic: Blinded Subject Event dataset

Country folder

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

Table 2-14 Data elements in the Country folder

Data element	Description
COUNTRY_NAME	Indicates a country's two-digit ISO code.

Parent topic: Blinded Subject Event dataset

Subject folder

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

Table 2-15 Data elements in the Subject folder

Data element	Description
SUBJECT_NUMBER	The number currently assigned to the subject in the system as identifier.
SUBJECT_STATE	A subject's state.
PREVIOUS_SUBJECT_NUMBER	When a subject number change is applied, this field holds the number that was assigned to the subject before the change.
SCREENING_NUMBER	Always displays the original screening number, assigned to the subject at screening.

Parent topic: Blinded Subject Event dataset

Event (Required) folder

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

Table 2-16 Data elements in the event folder

Data element	Description
FREEZE	Indicates if a visit is frozen by a data manager or CRA.
VERIFIED	Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified. UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified. VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
SIGNED	Indicates if a valid casebook signature is applied to the event.
IS_REQUIRED	Indicates if the visit is required.
IS_SCHEDULED_VISIT	Indicates if the visit is scheduled.
SCHEDULED_FROM_EVENT_NAME	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, as it is the first visit in the schedule.
VISIT_STATUS	Indicates a visit's status in the system. 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.
VISIT_START_DATE	Date stamp of a visit's start date.
VISIT_TYPE	Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion.
EVENT_TYPE	Displays the type of event that primarly 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.
EVENT_INSTANCE_NUM	Indicates the unscheduled visit instance number as designed by the study designer.
PROJECTED_VISIT_START_DATE	Date when the next scheduled visit should start in the study, based on the configured visit schedule.
PROJECTED_VISIT_END_DATE	Date when the next scheduled visit should end in the study, based on the configured visit schedule.
PROJECTED_VISIT_DATE	Date when the next scheduled visit should take place in the study, based on the configured visit schedule.
DELAY_DAYS	The number of days between the prior scheduled visit.
DELAY_HOURS	The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field).
VISIT_WINDOW_BEFORE_DAYS	Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer.
VISIT_WINDOW_BEFORE_HOURS	Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer.
VISIT_WINDOW_AFTER_DAYS	Indicates how many days after the scheduled date and time the visit can occur.
VISIT_WINDOW_AFTER_HOURS	Indicates how many hours after the scheduled date and time the visit can occur.
EVENT_TITLE	The event's title, defined by the user when an event is created.
EVENT_REFNAME	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 Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version.
EVENT_ID_NAME	The event's id as in Oracle Clinical One Platform.
VISIT_ORDER	The order in which subject visits occur, as configured in the study design.
IS_MISSING_VISIT	N (No) indicates that a standard visit has been started. Y (Yes) indicates that a standard (expected) visit has not been started. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred.
IS_OVERDUE_VISIT	Indicates whether the current date has passed the projected visit date.
SCHEDULED_FROM_EVENT_REFNAME	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 the visit’s own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule.

Parent topic: Blinded Subject Event dataset

Kit folder

This table describes the data elements in the Kit folder.

Table 2-17 Data elements in the Kit folder

Data element	Description
RAND_NUMBER	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.
KIT_NUMBERS	Indicates a kit's number, as assigned in the system.

Data element

Description

RAND_NUMBER

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.

KIT_NUMBERS

Indicates a kit's number, as assigned in the system.

Parent topic: Blinded Subject Event dataset

Audit folder

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

Table 2-18 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: Blinded Subject Event dataset

Aggregation folder

This table describes the data elements in the Aggregation folder.

Table 2-19 Data elements in the Aggregation folder

Data element	Description
FORM_TOTAL_COUNT	Count of all forms created as part of the study design.
FORM_COMPLETED_COUNT	Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form.

Parent topic: Blinded Subject Event dataset

Reference folder

Data element	Description
STUDY_WID	A number that represents the unique identifier of the study.
SITE_WID	A number that represents the unique identifier of a site.
SUBJECT_EVENT_INST_WID	A number that represents the unique identifier of a subject event's instance.
SUBJECT_WID	Indicates a subject's numeric identifier.
EVENT_WID	A number that represents the unique identifier of an event.
SCHEDULED_FROM_EVENT_WID	A number that represents the unique identifier of the previously scheduled event.
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.
COUNT	Represents the count of blinded events.
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: Blinded Subject Event dataset