Subject Event SVFL dataset

You can use the Subject Events SVFL dataset in Oracle Clinical One Analytics to analyze and visualize Sign, Verify, Freeze and Lock (SVFL) actions applied to an event or visit, as well as their audit history.

Modes

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

What type of data can I include in a custom report or visualization on subject event SVFL actions?

With this dataset, you can get relevant insights such as:

  • Identify all frozen, verified, or locked visits for a subject, or for all subjects within a site or study.
  • Review when SVFL actions took place for a visit in a study and when any of them were undone and why.
  • Get details on the timestamp and specific user who signed the visit.
  • Analyze metrics about how many times an investigator signs and unsigns objects within a casebook.
  • Retrieve the ALCOA audit details about how a signature changed.

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:

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.
  • Blank columns in Oracle Clinical One Analytics indicate null or not applicable.

Parent topic: Dataset descriptions

Study folder

This table describes the data elements included 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

The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode.

When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset:
  • P_01_A23 (for study version 1.0.2)
  • P01_A23_Production2 (for study version 1.0.3)
  • P01_A23_Production3 (for study version 1.0.4)
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 Event SVFL dataset

Site folder

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

Note:

Only a site's primary address is sent to Oracle Clinical One Analytics.
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 Event SVFL dataset

Country folder

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

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

Parent topic: Subject Event SVFL dataset

Subject folder

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

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

Parent topic: Subject Event SVFL dataset

Event (Required) folder

This table describes the data elements included 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 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.

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.

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. 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 dynamically triggered 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_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.

Parent topic: Subject Event SVFL dataset

Audit folder

This table describes the data elements included 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.
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.
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.

Parent topic: Subject Event SVFL dataset

Actions folder

This table describes the data elements included in the Actions folder:

Data element Description
ACTION_DATE The version start of the audit where the action was applied.
ACTION_OBJECT Indicates the refname of the Clinical One object where the action was applied.
ACTION_STATUS The resulting status after the action update. Possible values depend on the action type and can be:
  • SIGNED
  • UNSIGNED
  • FROZEN
  • UNFROZEN
  • VERIFIED
  • UNVERIFIED
  • LOCKED
  • UNLOCKED

Note: There will be no record for the initial state where no Action was applied. This is when the status for a given SVFL action to the object is <null>. For example, when the object is not currently signed and it has never been, so it cannot be unsigned either.
ACTION_TYPE Indicates the action that was updated for the given object. Possible values are:
  • SIGN
  • VERIFY
  • FREEZE
  • LOCK
ACTION_USER Indicates the user that performed the update to the action.

This field displays SYSTEM if it is not a direct action update and is instead the result of an automatic recalculation performed by the system or any other user action that indirectly impacts SVFL status.

OBJECT_TYPE Specifies if the action took place for the event itself or for the visit date.
SIGN_AFFIDAVIT_NAME Only applicable for sign actions.

Indicates the name of the affidavit that the signature displays to users for their endorsement.
SIGN_LEVEL Only applicable for sign actions.
Indicates the level at which the signature was applied:
  • Event
  • Form
  • Subject
SIGN_NAME Only applicable for sign actions.

The configured name of the signature.

Parent topic: Subject Event SVFL dataset

Reference folder

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

Data element Description
COUNT Represents the count of total 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.

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.
INTEGRATION_ID A number that represents the unique identifier of the configured integration, if applicable.
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_WID

Indicates a subject's numeric identifier.

USER_WID

Indicates a user's numeric identifier.

Parent topic: Subject Event SVFL dataset