Queries dataset

You can use the Queries dataset to analyze and visualize customized query 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 queries?

With this dataset, you can:

• View all queries in a state of Open and Answered to find a quick resolution.
• Identify form questions and items with the most queries across your study.
• Identify all questions with queries raised against them.
• Visualize visit dates alongside with the queries raised against them.

  Note:

  Queries on visit dates are associated with the following metadata:

  • FORM_NAME = 'Visit Date'
  • FORM_REFNAME = 'Visit Date'
  • ITEM_NAME = 'Visit Date'
  • REFERENCE_CODE = 'Visit Date'

  Other columns not applicable to visit date queries are null.

For information about permissions required to access this dataset, see About your access to Oracle Clinical One Analytics.

Note:

This dataset supports data classifications security. All data that you have access to view in Oracle Clinical One Platform will be visible to you.

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.

• Study folder
  
• Site folder
  
• Country folder
  
• Subject folder
  
• Event folder
  
• Form folder
  
• Item folder
  
• Query (Required) folder
  
• Audit folder
  
• Reference folder
  

Study folder

This table describes the data elements included in the Study folder

Table 2-26 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.

Note:

only a site's primary address is transmitted to Oracle Clinical One Analytics.

Table 2-27 Data elements in the Site folder

Data element	Description
PI_PREFIX	Indicates the principal investigator's prefix, as configured by a site manager
ADD_SUBJECTS	Indicates whether a site is restricted from adding subjects, as configured by a site manager
SCREEN_SUBJECTS	Indicates whether a site is restricted from screening subjects, as configured by a site manager
RANDOMIZE_SUBJECTS	Indicates whether a site is restricted from randomizing subjects, as configured by a site manager
DISPENSE_TO_SUBJECTS	Indicates whether a site is restricted from dispensing kits to subjects, as configured by a site manager
DEA_NUMBER	Indicates the DEA Registration Number as defined by a site manager
EXPIRATION	Indicates the expiration date of the DEA Registration Number as defined 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
SHIPPING_ATTENTION	Indicates the name of the person who will receive shipments at the site, as specified by a site manager
SDV_GROUP_NAME	Name of the SDV Strategy, as entered by the study manager
INITIAL_SUBJECTS_COUNT	Indicates the number of initial subjects at a site whose data must be verified by a CRA, as specified by a study manager
INITIAL_SUBJECTS_SDV_TYPE	Indicates the type of source data verification to be performed by a CRA for the data of initially enrolled subjects, as specified by a study manager
REMAINING_SUBJECTS_PERCENTAGE	Indicates the percentage of remaining subjects to be eligible for source data verification, as specified by a study manager
REMAINING_SUBJECTS_SDV_TYPE	Indicated the type of source data verification to be performed by a CRA for the data of the remaining subjects, as specified by a study manager
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
ADDRESS_CITY	A site's city as entered by the site manager when they created or last modified the site
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_POSTALCODE	The Zip Postal Code associated with a site's address
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
PHONE	The contact phone number as entered by the site manager when they created or last modified the site
FAX	The contact fax number as entered by the site administrator when they created or last modified the site
EMAIL	Email address of the site as entered by the site administrator when they created or last modified the site
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 shipping address as entered by the site manager when they created or last modified the site
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_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
SHIPPING_PHONE	Phone number associated with the shipping address
SHIPPING_FAX	Fax number associated with the shipping address
SHIPPING_EMAIL	Email address associated with the shipping address

Country folder

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

Table 2-28 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 2-29 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.

Event folder

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

Table 2-30 Data elements in the event folder

Data element	Description
VISIT_IS_REQUIRED	Indicates if a 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: 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).
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.
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.
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.

Form folder

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

Table 2-31 Data elements in the Form folder

Data element	Description
FORM_NAME	The name of the form, as specified by the study designer.
IS_ROLLOVER	Indicates whether the form contains a rollover type of question.
IS_REPEATING	Indicates if it is a repeating form.
FORM_STATUS	Can have one of the following values: COMPLETED COMPLETE_WITH_ERRORS IN_PROGRESS INCOMPLETE INCOMPLETE_WITH_ERRORS SCHEDULED BLANK
FORM_REFNAME	A form's reference name.
REPEAT_FORM_NUMBER	Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number. Lab forms: defaulted to a value of 1. Repeating forms: this value will be null.

Item folder

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

Note:

There is a record for every change applied in Oracle Clinical One Platform. For each query, the query item displays the value at the time the query was raised. If a user updates the item and automatically closes the query or manually updates the query status, a new record is created and, for that record, the item displays its value at the time of the update.

Table 2-32 Data elements in the Item folder

Data element	Description
ITEM_NAME	Indicates the title of the question, as entered by a study designer.
VALIDATION_STATUS	Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken.
VALUE	The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts.
MEASURE_UNIT	Indicates the measure of unit specified by a study designer for a Number type of question.
NORMALIZED_VALUE	Currently not populated.
VALIDATION_FAILURE	Reason for failure if validation status is failed or the rule validation failed.
NUM_VALUE	If the question type is a calculation, measurement, or number, this field is populated with that number.
FLOAT_VALUE	Item value without decimal places, if precision is provided in the study design.
UTC_DATETIME_VALUE	Indicates the date and time in UTC for a Date/Time type of question.
MONTH_VALUE	If the question type is Date/Time, this field is populated with the month value (1-12).
DAY_VALUE	If the question type is Date/Time, this field is populated with the day value (1-31).
YEAR_VALUE	If the question type is Date/Time, this field is populated with the year value (i.e. 2021).
HOUR_VALUE	If the question type is Date/Time, this field is populated with the hour value (0-23).
MINUTE_VALUE	If the question type is Date/Time, this field is populated with the minute value (0-59).
SECOND_VALUE	If the question type is Date/Time, this field is populated with the second value (0-59).
ITEM_D	Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts.
ITEM_R	The raw value: alphanumeric value as entered in Oracle Clinical One Platform with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts.
ITEM_F	The formatted value: value as entered in Oracle Clinical One Platform converted to the question data type as per form design. For more details see Form item output mapping in data extracts.
ITEM_TYPE	The form item's question type.
QUESTION_TYPE	Indicates the type of question as defined by a study designer.
QUESTION_HINT	Indicates information that a study designer provided as a hint to help answer a question.
FORMITEM_IS_REQUIRED	Indicates if the question is required. Required questions must be answered in order to save the form that contains it.
READONLY	Indicates that the question is marked as read-only by a study designer.
SAS_VARIABLE	Indicates the SAS Variable of a form defined by a study designer.
SAS_LABEL	Indicates the SAS Label of a form defined by a study designer.
REFERENCE_CODE	Indicates a question's reference code.
HIDDEN	Indicates if a question is hidden, as marked by a study designer.
FREEZE	Indicates if a question is frozen by a data manager or CRA.
VERIFIED	Indicates the question'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. Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics.
SIGNED	Indicates whether a question is signed by a PI.

Query (Required) folder

This table describes the data elements included in the Query (Required) folder.

Data element	Description
STATE	Indicates a query's status: Opened Answered Closed Candidate query
HAS_QUERY	Indicates if there is a query raised against a question, irrespective of the status.
ASSIGNED_ROLES	Indicates the roles that are assigned to receive a query.
QUERYAGE	Indicates the number of days passed since a query was first opened.
QUERY_COMMENT	Indicates a comment associated with a query, as entered by the user who last modified the query.
IS_AUTO_QUERY	Indicates whether this is an automated query.
QUERY_TYPE	Indicates the query type.
PROPERTY_NAME	Name of the property to which the query is associated to. This only applies to queries on visit dates and the default is visitStartDate. Note: For other queries, this value is null.
PROPERTY_TYPE	Type of property to which the query is associated to. This only applies to queries on visit dates and the default is visit. Note: For other queries, this value is null.

Audit folder

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

Table 2-33 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).
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.
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.
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.

Reference folder

This table describes data elements in the Reference folder.

Table 2-34 Data elements in the Reference folder

Data element	Description
QUERY_WID	A number that represents unique identifier of a query.
STATE_ID	Numeric value that represents a query state.
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.
EVENT_INSTANCE_NUM	Indicates the unscheduled visit instance number as designed by the study designer.
FORM_WID	A number that represents the unique identifier of a form.
REPEAT_SEQUENCE_NUMBER	Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section. Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results. Repeating forms: indicates the repeating form number.
ITEM_WID	A number that represents the unique identifier of an item.
SOFTWARE_VERSION_NUMBER	A number that represents an incremental increase every time a data point is modified.
USER_WID	Indicates a user's numeric identifier.
DH_TIMESTAMP	A timestamp that indicates when the data became available in the dataset.
SUBJECT_EVENTINST_FORMITEM_WID	A number that represents the unique identifier of an item within a subject form associated with a specific visit instance.
SUBJECT_EVENT_INST_WID	A number that represents the unique identifier of a subject event's instance.
PARENT_WID	Currently not populated.
ROOT_WID	Currently not populated.
SCHEDULED_FROM_EVENT_WID	A number that represents the unique identifier of the previously scheduled event.
COUNT	Represents the count of queries.
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.