Subject Form Items dataset

You can use the Subject Form Items dataset in Oracle Clinical One Analytics to analyze and visualize item-level data and the audit history of data entered for a question in a form for individual subjects.

Modes

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

What type of data can I include in a custom report or visualization on questions?

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

All the form questions and answers that have been completed for a specific subject.
All the incomplete form items by visit for all active subjects. Or how many subjects have an incomplete form at a specific site for a particular visit.
All subjects with a specified answer value.
Show all missing forms and questions for a subject.
How many form items that require verification are there pending to be verified for a subject, site or study.
Calculate the completion percentage of SDV, either for the entire study, by subject or by site.
Build a report to project how much data will be collected at a site over a period of time to schedule monitoring visits.
Identify all questions with queries raised against them. Including visit dates.
For this use case, consider that queries on visit dates are associated to 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.

Browse descriptions of data elements included in this dataset:

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.
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 2-53 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: Subject Form Items 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 2-54 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: Subject Form Items dataset

Country folder

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

Table 2-55 Data elements in the Country folder

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

Parent topic: Subject Form Items dataset

Subject folder

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

Table 2-56 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: Subject Form Items dataset

Event folder

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

Table 2-57 Data elements in the event folder

Data element	Description
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).
EVENT_ID_NAME	The event's id as in Oracle Clinical One Platform.
EVENT_INSTANCE_NUM	Indicates the unscheduled visit instance number as designed by the study designer.
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_TITLE	The event's title, defined by the user when an event is created.
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.
IS_SCHEDULED_VISIT	Indicates if the visit is scheduled.
PROJECTED_VISIT_DATE	Date when the next scheduled visit should take place 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_START_DATE	Date when the next scheduled visit should start in the study, based on the configured visit schedule.
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_IS_REQUIRED	Indicates if a visit is required.
VISIT_ORDER	The order in which subject visits occur, as configured in the study design.
VISIT_START_DATE	Date stamp of a visit's start date.
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_TYPE	Displays the type of visit: Screening, Randomization, Dispensation, Non-Dispensation, Optional, Withdrawal or Study Completion.
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_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.
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: Subject Form Items dataset

Form folder

Note:

If a form contains a hidden and required question that wasn’t answered, the status of the form is considered Incomplete and reflected in the FORM_STATUS data element, despite its status being displayed as Complete in the Oracle Clinical One Platform.

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

Table 2-58 Data elements in Form folder

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

Parent topic: Subject Form Items dataset

Item (Required) folder

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

Table 2-59 Data elements in the Item folder

Data Element	Description
DAY_VALUE	If the question type is Date/Time, this field is populated with the day value (1-31).
FLOAT_VALUE	Item value without decimal places, if precision is provided in the study design.
FREEZE	Indicates if a question is frozen by a data manager or CRA.
HIDDEN	Indicates if a question is hidden, as marked by a study designer.
HOUR_VALUE	If the question type is Date/Time, this field is populated with the hour value (0-23).
IS_REQUIRED	Indicates if the question is required. Required questions must be answered in order to save the form that contains it.
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_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_NAME	Indicates the title of the question, as entered by a study designer.
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_TYPE	The form item's question type.
MEASURE_UNIT	Indicates the measure of unit specified by a study designer for a Number type of question.
MINUTE_VALUE	If the question type is Date/Time, this field is populated with the minute value (0-59).
MONTH_VALUE	If the question type is Date/Time, this field is populated with the month value (1-12).
NORMALIZED_VALUE	Currently not populated.
NUM_VALUE	If the question type is a calculation, measurement, or number, this field is populated with that number.
QUESTION_HINT	Indicates information that a study designer provided as a hint to help answer a question.
QUESTION_TYPE	Indicates the type of question as defined by a study designer.
READONLY	Indicates that the question is marked as read-only by a study designer.
REFERENCE_CODE	Indicates a question's reference code.
SAS_LABEL	Indicates the SAS Label of a form defined by a study designer.
SAS_VARIABLE	Indicates the SAS Variable of a form defined by a study designer.
SECOND_VALUE	If the question type is Date/Time, this field is populated with the second value (0-59).
SIGNED	Indicates if a valid casebook signature is applied to the item.
UTC_DATETIME_VALUE	Indicates the date and time in UTC for a Date/Time type of question.
VALIDATION_FAILURE	Reason for failure if validation status is failed or the rule validation failed.
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.
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.
YEAR_VALUE	If the question type is Date/Time, this field is populated with the year value (i.e. 2021).
LAB_ID	Indicates the associated lab ID, when the item is part of a lab form.
LAB_NAME	Indicates the associated lab name, when the item is part of a lab form.
HAS_QUERY	Indicates if there is a query raised against a question, irrespective of the status.
SDV_SELECTED_STATUS	Indicates if, after all applicable Source Data Verification (SDV) settings combined, the question requires verification or not for the subject. This is determined based on the study SDV settings, the SDV strategy assigned to the site, whether the subject is part of the pool of selected subjects for SDV, and SDV settings defined at the item level in form design. For more information, see Understand Source Data Verification. This data element is populated with four possible values: OBLIGATORY: the question requires verification. This means that either the study has a 100% SDV configuration or it has a Targeted SDV configuration and the question is selected for SDV for that given subject. OPTIONAL: the question may be verified but it is not required for that given subject. This is only applicable for Targeted SDV studies that allow SDV overrides. OPTIONAL_CRITICAL: the question is set as a critical variable but the subject is not part of the SDV subject pool, hence the question may be verified but it is not required for that given subject. This is only applicable for Targeted SDV studies that allow SDV overrides. IRRELEVANT: the question is not configured for SDV for this subject and it is not expected to be verified. This would be the case of: Read-only questions. Studies set up for no SDV. Studies with Targeted SDV configuration that don't allow SDV overrides. Screen failed subjects when excluded from SDV.

Parent topic: Subject Form Items dataset

Audit folder

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

Table 2-60 Datat elements in the audit folder

Data element	Description
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.
OBJECT_VERSION_NUMBER	Audit trail field that represents the version number of the data.
OPERATION_TYPE	Audit trail field that represents the type of operation performed (i.e. create, modify).
REASON	Indicates a reason for changes in a subject's data. Populated by drop-down list.
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.
VERSION_END	Indicates the date and time of when data was changed, if the data is not current.
VERSION_START	Indicates the date and time of when the data was changed.
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.
EHR_IMPORTED	Indicates if a question was populated via an Electronic Health Record (EHR) data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes.

Parent topic: Subject Form Items dataset

Reference folder

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

Data Element	Description
DH_TIMESTAMP	A timestamp that indicates when the data became available in the dataset.
EVENT_WID	A number that represents the unique identifier of an event.
FORM_WID	A number that represents the unique identifier of a form.
ITEM_WID	A number that represents the unique identifier of an item.
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.
SITE_WID	A number that represents the unique identifier of a site.
SOFTWARE_VERSION_NUMBER	A number that represents an incremental increase every time a data point is modified.
STUDY_WID	A number that represents the unique identifier of the study.
SUBJECT_EVENT_INST_WID	A number that represents the unique identifier of a subject event's instance.
SUBJECT_EVENTINST_FORM_WID	A number that represents the unique identifier of a subject form associated with a specific visit instance.
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_WID	Indicates a subject's numeric identifier.
USER_WID	Indicates a user's numeric identifier.
COUNT	Represents the count of items.
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 Form Items dataset