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. 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.

Parent topic: Subject Event SVFL dataset

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.

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.

Parent topic: Subject Event SVFL dataset

Country folder

This table describes the data elements included 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.

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 its identifier within the study.

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. Values can be:
  • New: The subject was added to the study but has not been screened yet.
  • Screen_Failed: The subject was manually screen failed by a site user.
  • Auto_Screen_Failed: The subject failed the validations required for screening.
  • Screening_initiated: When a subject is Screened , Oracle Clinical One Analytics displays screening_initiated until the next visit is complete and the subject becomes Active.
  • Active: The subject is currently active in an ongoing study.
  • Complete: The subject completed the study.
  • Withdrawn: The subject was withdrawn from the study.
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 Clinical One Cloud Service.
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 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_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. Upon selecting this data element, only events that occurred in your study are displayed. This data element displays any of the following events:
  • VisitDateCleared: the visit date was cleared.
  • VisitDateEntered: the visit date was entered.
  • VisitDispensed: dispensation occurred during the visit.
  • VisitRandomized: randomization occurred during the visit.
  • VisitRandomizedDispensed: dispensation and randomization occurred during the visit.
  • VisitScreened: screening occurred during the visit.
  • Visit_Complete: the visit was completed.
  • Visit_Date_Changed: the visit date was changed.
  • Visit_Hide: the visit was hidden.
  • Visit_Inserted: a new visit is inserted into the study's schedule as an Advanced Study Versioning change.
  • Visit_Not_Started: the visit is associated to the subject but is not yet started.
  • Visit_Show
  • Visit_Skip_Undone: the visit was previously skipped, but the skip action was undone.
  • Visit_Skipped: the visit was skipped for the subject.
  • Visit_Started: the visit was started for the subject but hasn't progressed all the way to complete.
  • Visit_Scheduled: the visit is associated to the subject as part of their schedule.
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, if 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 that visit’s own refname..

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 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_TYPE Displays the type of visit:
  • Screening
  • Randomization
  • Dispensation
  • Non-Dispensation
  • Optional
  • Withdrawal
  • 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 This data element may contain Clinical One Cloud Service system-generated values populated by asynchronous event processing, depending on the record type and workflow.

This field is intended for internal system context and should not be relied on for analytic interpretation.
CURRENT_STUDY_ROLE_NAME Specifies of the role of the user who performed the action associated to the given record.

Even if the user's study role changes, this field always shows the current study role of the given user.
IS_CURRENT Audit trail field to indicate if the record represents current data. Displays:
  • Y for Yes.
  • N for No.
OBJECT_VERSION_NUMBER Audit trail field that represents a sequential number for records about operations on a same element.
OPERATION_TYPE Audit trail field that represents the type of operation performed on the record:
  • CREATED: a given action resulted in a new record.
  • MODIFIED: a given action resulted in the update of an existing record.
  • REMOVED: a given action resulted in the data removal for an existing record.
  • CLEARED: a given action resulted in the clearing of data for an existing record.
REASON Indicates a reason for the applied changes on the record, if applicable. Otherwise this field is blank.

The reason for change is specified by selecting an option from a drop-down list of options, which is populated with the labels from a 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.

USER_NAME

Audit trail field that represents the user who performed the action that generated the record.

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

As this dataset contains past and current records, the version end indicates the date and time when a change was applied that made the given record to stop being current.

If the record is current, then the version end is not defined, and '31/12/3099 12:00:00 a.m.' displays by default.

VERSION_START

As this dataset contains past and current records, the version start indicates the date and time when a given record was created.

To be used in combination with VERSION_END to determine if the record is current or version ended.

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.

Note:

Although WID values are unique identifiers at the study level, they may change over product releases and should not be used as identifiers in your reports.
Data element Description

COUNT

Represents the count of records in the dataset.

CURRENT_STUDY_ROLE_WID

A number that represents the role of the user who updated the given record, as a unique identifier within the study.

Even if the user study role changes, this field always shows 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 event, as a unique identifier within the study.
INTEGRATION_ID Identifier of the integration that generated the given record, when applicable.
SCHEDULED_FROM_EVENT_WID

A number that represents the parent visit from which the associated visit was scheduled, as a unique identifier within the study.

SITE_WID

A number that represents the site, as a unique identifier within the study.

SOFTWARE_VERSION_NUMBER

A number that increases incrementally every time a data point is modified.

STUDY_WID

A number that represents the site, as a unique identifier.
SUBJECT_EVENT_INST_WID

A number that represents the subject's event instance, as a unique identifier within the study.

SUBJECT_WID

A number that represents the subject, as a unique identifier within the study.

USER_WID

A number that represents the user, as a unique identifier within the study.

Parent topic: Subject Event SVFL dataset