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 frozen, verified, or locked visits for a subject, or for all subjects within a site or study.
• 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.

• 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 3-12 Data elements in the Study folder

Data element	Description
STUDY_MODE	Indicates the study mode used in the referencing data in a custom report. Values can be Testing Training Active
STUDY_ID_NAME	The study ID as specified when the study was created. The study ID typically includes the protocol acronym or protocol number and must be unique within a tenant. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.
STUDY_TITLE	The Study Title as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings.
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	The study phase as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings. The study phase is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.studyPhase codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.
THERAPEUTIC_AREA	Indicates the therapeutic area as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings. The therapeutic area is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.therapeuticArea codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.
BLINDING_TYPE	Indicates the blinding type of the study (whether the study is open-label or blinded) as specified when the study was created. You can view or update this value in Clinical One Cloud Service from the General tab of the Study's settings. The blinding type is specified by selecting an option from a drop-down list of options, which is populated with the labels from the studyGeneralSettings.openLableBlinded codelist within the system codelist selected for the study. Users with the appropriate permissions can update codelists used within a study at any time. See Create and manage code lists.
STUDY_VERSION	Indicates the study version of the referencing data in a custom report. The study version is associated to a subject and corresponds to that on which a subject was added to the study. This value does not change for a subject, regardless of the creation of new study versions for a given mode.

Site folder

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

Note:

A site may have multiple addresses added that are used for different purposes (primary address, shipping address, billing address, alternate address), but only one address can and must be configured as the main primary address.

• Only a site's main primary address is transmitted to Oracle Clinical One Analytics for the address data elements (those starting with ADDRESS_).
• The shipping address data elements (those staring with SHIPPING_) return the site's shipping address details only if added in Clinical One Cloud Service, otherwise it will return null.

  If a site has multiple shipping addresses, only the first entered shipping address is transmitted to Oracle Clinical One Analytics.

Table 3-13 Data elements in the site folder

Data element	Description
ADD_SUBJECTS	Setting defined at the study site level to allow site users to add subjects. Values can be: true false
ADDRESS_CITY	The city of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_COUNTRY	The country of the site's main primary address, as entered when the site was created or last modified. This field displays the country's two-digit ISO code.
ADDRESS_POSTALCODE	The zip postal code of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STATE_OR_PROV_OR_CNTY	The state, province or county of the site's main primary address, as entered when the site was created or last modified.
ADDRESS_STREET_1	The first line of the site's main primary address, as entered in the Address Line 1 field when the site was created or last modified.
ADDRESS_STREET_2	The second line of the site's main primary address, as entered in the Address Line 2 field when the site was created or last modified.
DEA_NUMBER	The DEA registration number of the site's contact.
DISPENSE_TO_SUBJECTS	Setting defined at the study site level to allow site users to dispense kits to subjects. Values can be: true false
DRUG_DESTRUCTION_CAPABLE	Indicates if the site has drug destruction capabilities. Values can be: true false
EMAIL	The email address associated to the site's main primary address, as entered when the site was created or last modified.
EXPIRATION	The expiration date of the DEA registration number of the site's contact.
FAX	The fax number associated to the site's main primary address, as entered when the site was created or last modified.
INITIAL_SUBJECTS_COUNT	Total count of initial subjects in a site that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
INITIAL_SUBJECTS_SDV_TYPE	Type of Source Data Verification (SDV) applied to initial subjects, as defined in the SDV strategy. Values can be: All Questions - meaning all questions must be verified for the subject. Critical Questions Only - meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
PHONE	The phone number associated to the site's main primary address, as entered when the site was created or last modified.
PI_PREFIX	Indicates the prefix for the site's principal investigator. Values can be: First Liutenant Admiral Attorney Brother Captain Chief Commander Colonel University Dean Doctor Elder Father General Fees Honorable Liutenant Colonel Major Major/Master Sergeant Mister Married Woman Single or Married Woman Prince Professor Rabbi Reverend Sister
RANDOMIZE_SUBJECTS	Setting defined at the study site level to allow site users to randomize subjects. Values can be: true false
REMAINING_SUBJECTS_PERCENTAGE	Percentage of remaining subjects in a site, after the initial subjects, that must undergo Source Data Verification (SDV). This is according to the SDV strategy assigned to the site.
REMAINING_SUBJECTS_SDV_TYPE	Type of Source Data Verification (SDV) applied to the remaining subjects, as defined in the SDV strategy. Values can be: All Questions - meaning all questions must be verified for the subject. Critical Questions Only - meaning only the questions marked as either SDV for All Subjects or Critical Variable (Targeted SDV) must be verified for the subject.
SCREEN_SUBJECTS	Setting defined at the study site level to allow site users to screen subjects. Values can be: true false
SDV_GROUP_NAME	Name of the SDV strategy that is associated with the site. This name is entered by the user when creating an SDV strategy.
SHIPPING_ADDRESS_1	The first line of the site's shipping address, as entered in the Address Line 1 field when the site was created or last modified.
SHIPPING_ADDRESS_2	The second line of the site's shipping address, as entered in the Address Line 2 field when the site was created or last modified.
SHIPPING_ATTENTION	Indicates the name of the person who will receive shipments at the site, as specified when the site was created or last modified.
SHIPPING_CITY	The city of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_COUNTRY	The country of the site's shipping address, as entered when the site was created or last modified. This field displays the country's two-digit ISO code.
SHIPPING_EMAIL	The email address associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_FAX	The fax number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_PHONE	The phone number associated to the site's shipping address, as entered when the site was created or last modified.
SHIPPING_STATE_OR_PROV_OR_CNTY	The state, province, or county of the site's shipping address, as entered when the site was created or last modified.
SHIPPING_ZIP	The zip postal code of the site's shipping address, as entered when the site was created or last modified.
SITE_ID_NAME	The site ID, as entered when the site was created or last modified.
SITE_STATUS	Indicates the status of the site within the study. Values can be: New: the site is new within the study. Active: the site is currently active within the study. Retired: the site is no longer active in the study.
SITE_STUDY_VERSION	The latest study version associated with the site. This is defined in the Sites & Labs tab of the study's settings.
TIMEZONE	Indicates the time zone for the site, as specified when the site was created or last modified. Values can be, for example, EST5EDT or America/New_York. Depends on the selected value in Clinical One Cloud Service.
INVESTIGATOR	Last name of the principal investigator associated with the site.
SITE_NAME	Name of the site, as entered when the site was created or last modified.
SITE_TYPE	Indicates the type of organization. Values can be: Site Depot
EHR_ENABLED	Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. Displays Y (yes) for sites currently enabled for EHR data import. Displays N (no) if EHR has never been enabled for a site or if a site was disabled for EHR.

Country folder

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

Table 3-14 Data elements in the Country folder

Data element	Description
COUNTRY_NAME	The country of the site's main primary address, as entered when the site was created or last modified. This field displays the country's two-digit ISO code.

Subject folder

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

Table 3-15 Data elements in the Subject folder

Data element	Description
SUBJECT_NUMBER	The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature.
SUBJECT_STATE	A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, Oracle Clinical One Analytics displays screening_initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed , Oracle Clinical One Analytics displays auto_screen_failed.
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 (Required) folder

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

Table 3-16 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, if it is the first visit in the schedule.
VISIT_STATUS	Indicates a visit's status in the system. Can have one of the following values: COMPLETED: all required items within the visit are completed and there are no open queries. COMPLETED_ERR: all required items within the visit are completed but there are open queries. INCOPLETE: the visit was completed at some point but now has one or more required items that are not completed. INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries. IN_PROGRESS: the visit was never completed and has one or more required items with no saved data. NEW: the visit was either dynamically triggered or added as part of Advanced Study Versioning (ASV) and has no data. SCHEDULED: the visit is scheduled for the subject but has no data. Note: 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. SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user. UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
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 Study Completion
EVENT_TYPE	Displays the type of event that 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 Clinical One Cloud Service 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 Clinical One Cloud Service.
VISIT_ORDER	The order in which subject visits occur, as configured in the study design.
IS_MISSING_VISIT	N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. 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 that visit’s own refname..
LOCKED	Indicates the lock status of the given visit. This field can have the following values: <null>: No lock has ever been applied to this visit. LOCKED: All objects within the visit are currently locked. UNLOCKED: The visit has no locks applied after being locked at one point in the past. Note: Event or visit locking applies to the entire visit, including the Visit Date. For a visit to be marked as LOCKED, the Visit Date and all associated objects must be locked. If the Visit Date is not locked, the visit cannot be locked.
SDV_SELECTION_VISIT_DATE	This element tracks visit dates for visits that are part of the targeted SDV pool for a subject tied to the record. The possible values include: OBLIGATORY OPTIONAL OPTIONAL_CRITICAL IRRELEVANT

Kit folder

This table describes the data elements in the Kit folder.

Table 3-17 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.

Audit folder

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

Table 3-18 Data elements in the audit folder

Data element	Description
VERSION_START	Indicates the date and time of when the data was changed. This data element indicates the first timestamp in the system where it was known that the subject should be completing that form for the following scenarios: For dynamic forms, this is when the form is triggered. For forms in scheduled visits, the temporal information matches the timestamp of the visit that contains it, and this information comes from the study design.
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 on the record: CREATED MODIFIED REMOVED CLEARED Note: For form records in skipped visits, OPERATION_TYPE is set to CLEARED.
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. Note: For repeating forms, 2-section, and lab forms, this element is associated with both form-level records and row-level records. For form records in skipped visits, forms are not current and IS_CURRENT is set to N.
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 3-19 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.

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 increases incrementally 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 records in the dataset.
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.