Unblinded Subject Event dataset

You can use the Unblinded Subject Events dataset in Oracle Clinical One Analytics to analyze and visualize unblinded data from 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 an unblinded custom report or visualization?

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

• All the week 3 visits for a site that have not been completed
• All the subjects that have completed a screening visit in a country
• All skipped visits for a subject.
• 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.

The unblinded subject event dataset consists of numerous elements that differ from the blinded subject event dataset. Browse the descriptions of the data elements exclusive to the Unblinded Subject Event dataset:

Data element	Description
KIT_TYPE_SRC_ID	A kit type's ID as entered by a study designer when the kit was created
INVENTORY_STATUS_ID	Number value that maps to the INVENTORY_STATUS column
INVENTORY_STATUS	The status of the kit
DISPENSATION_DATE	Date of the kit dispensation
MHEALTH_DEVICE_ID	The ID of an IoT-enabled device managed with Oracle Health Sciences mHealth Connector Cloud Services
DOSAGE	Dosage for the kit dispensed
BAR_CODE	If included in a study, this indicated a kit's barcode as generated by the system
DISPENSATION_CONFIRMED	Indicates whether a kit's dispensation was confirmed by a site user or not
MEASUREMENT	Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer
FREQUENCY	Indicates the dosing frequency as defined by a study designer
RETURNED_UNITS	Number remaining in the kit as indicated by the site user or Clinical Research Associate (CRA)
MISSING_UNITS	Number of lost or damaged units in the kit as indicated by the site user
CONSERVED	Indicates whether a kit was conserved by a site user or not
KIT_DESCRIPTION	Indicates a kit's description, as defined by a study designer, the amount of dispensed kits,
QUANTITY	Kit quantity is defined in study design
TREATMENT_NAME	Indicates the treatment arm title as entered by a study designer
RANDOMIZATION_DATE	Indicates the date and time of when a subject is randomized
RND_STATUS	Randomization status of the subject
COHORT_NAME	Name of the cohort part of the randomization design
INSTANCE_NUMBER	The repeat instance number of the visit

Browse the descriptions of other data elements included in this dataset:

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

Study folder

This table describes the data elements included in the Study folder

Table 2-77 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.

Site folder

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

Table 2-78 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_TYPE	Indicates the type of organization.

Country folder

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

Table 2-79 Data elements in the Country folder

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

Subject folder

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

Table 2-80 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.
UNBLIND_COMMENT	Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment.
UNBLIND_DATE	Indicates the date when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date.
UNBLIND_REASON	Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason.

Event (Required) folder

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

Table 2-81 Data elements in the event folder

Data element	Description
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.
FREEZE	Indicates whether a visit is frozen or not by a data manager or CRA.
VERIFIED	Indicates whether a visit is verified or not by a CRA. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified. UNVERIFIED: A question, form, or visit is not verified. VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
SIGNED	Indicates whether a question is signed by a PI or not.
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: 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).
EVENT_INSTANCE_NUM	Indicates the unscheduled visit instance number as designed by the study designer.
PROJECTED_VISIT_START_DATE	Date when the next scheduled dispensation should start in the study.
PROJECTED_VISIT_END_DATE	Date when the next scheduled dispensation should end in the study.
PROJECTED_VISIT_DATE	Date when the next scheduled dispensation should take place in the study.
IS_REQUIRED	Indicates whether the visit is required or not.
IS_SCHEDULED_VISIT	Indicates whether the visit is scheduled or not.
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.
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.
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.

Kit folder

This table describes the data elements in the Kit folder.

Table 2-82 Data elements in the kit folder

Data element	Description
KIT_NUMBER	Indicates a kit's number, as assigned in the system.
INVENTORY_STATUS	Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have?.
DISPENSATION_DATE	Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject.
DOSAGE	Indicates the dosage for the dispensed kit, when the kit contains calculated doses.
BAR_CODE	If included in a study, this indicates a kit's barcode as generated by the sysem.
DISPENSATION_CONFIRMED	Indicates whether a kit's dispensation was confirmed by a site user or not
MEASUREMENT	Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer
FREQUENCY	Indicates the dosing frequency as defined by a study designer
RETURNED_UNITS	Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA)
MISSING_UNITS	Number of lost or damaged units in the kit as indicated by the site user
CONSERVED	Indicates whether a kit was conserved by a site user or not
KIT_DESCRIPTION	Indicates a kit's description, as specified by the study designer when they created the kit type.
QUANTITY	Indicates a kit's quantity, as specified by the study designer.
TREATMENT_NAME	Indicates the title of the treatment arm from the protocol, as specified by the study designer when they created the treatment arm in Study Design mode. Displays the title for every treatment arm created in the study.
RAND_NUMBER	Indicates the randomization number assigned to each randomized subject in a study.
RANDOMIZATION_DATE	Indicates the date on which a subject has been randomized in the study.
RND_STATUS	Indicates whether a subject has been randomized or not in a study. If randomized, a subject's status must be updated to Active. If a subject is not randomized, their status can be: New: If they're newly enrolled in the study at the time that you are creating a report using this data element. Screened: If they're screened in the study at the time that you are creating a report using this data element. Enrolled: If they're enrolled in the study at the time that you are creating a report using this data element, but they have been screened in a different system outside of Oracle Clinical One Platform.
COHORT_NAME	Indicates the type of cohort selected by a study designer when creating a randomization design: None: this indicates that the study has no cohorts Adaptive: this indicates that the study contains cohorts that allow site staff to open treatment arms in a gradual manner so that the study team can better measure safety and efficacy as the study progresses. Demography: this indicates that the study contains population groups according to demographic criteria, such as age.
INSTANCE_NUMBER	Indicates the repeat instance number of the visit
TITRATION	Indicates if a kit type is part of a kit type titration or not. Values can be 1 or 0.
TREATMENT_ARM_DESCRIPTION	Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode.
TREATMENT_ARM_TITLE	Indicates the title of the treatment arm from the protocol, as specified by the study designer when they created the treatment arm in Study Design mode. Displays the title for every treatment arm created in the study.

Audit folder

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

Table 2-83 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 folder

This table describes the data elements in the Aggregation folder.

Table 2-84 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.

Reference folder

Data element	Description
INVENTORY_STATUS_ID	A number that represents the unique identifier of the inventory status.
SUBJECT_EVENT_INST_WID	A number that represents the unique identifier of a subject event's instance.
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_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.
TREATMENT_WID	A number that represents the unique identifier of a treatment arm.
RND_STATUS_ID	Indicates the numeric identifier of the randomization status.
COHORT_WID	Indicates a cohort's numeric identifier.
COUNT	Represents the count of 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.