Subject Form SVFL dataset

You can use the Subject Form SVFL dataset in Oracle Clinical One Analytics to analyze and visualize Sign, Verify, Freeze and Lock (SVFL) actions applied to a form, as well as their audit history.

Note:

For repeating form instances, the Subject Form SVFL dataset now tracks instance-level statuses for all newly collected data, providing complete audit points going forward. Historical data is different: past repeating form instances don't include instance-level SVFL statuses, so you may see gaps when reviewing older records. Item-by-item actions are still tracked for the data itself, as well as at the visit level, but detailed status information at the form-instance level is only available for new data collected after this update.

You can rely on full-instance level status and audit history for repeating forms from now on, but historical repeating form data will not retroactively include these details.

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 form SVFL actions?

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

  • Identify all frozen, verified, or locked forms for a subject, or for all subjects within a site or study.
  • Review when SVFL actions took place for a form in a study and when any of them were undone and why.
  • Get details on the timestamp and specific user who signed the form.
  • 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.
  • Identify what forms are available for source data verification (SDV) at a particular site that have recently become unverified.
  • Analyze the percentage of signed and verified forms against the total forms or the unsigned and unverified counts.

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 Form 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 Form 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 Form 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.

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.
SCREENING_NUMBER Always displays the original screening number, assigned to the subject at screening.

Parent topic: Subject Form SVFL dataset

Event 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'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, 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 Form SVFL dataset

Form (Required) folder

This table describes the data elements included in the Form (Required) 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 Clinical One Cloud Service.
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 The status of the given form. Can have one of the following values:
  • COMPLETED: all required items are completed with no open queries.
  • COMPLETE_WITH_ERRORS: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.
  • IN_PROGRESS: the form was never completed and has one or more required items not completed.
  • INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.
  • INCOMPLETE_WITH_ERRORS: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.
  • SCHEDULED: the form is new and has no data entered for it.
  • DELETED: All questions in a form have been cleared or skipped and the form is considered deleted. Forms with skipped visit items can include the a status flag NOT ANSWERED, indicating that eligible flat form items associated with the skipped visit were incomplete (left blank or partially filled).
  • BLANK: indicates null or not applicable.
  • OPTIONAL: the form does not have any required or completed items.
  • NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
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.
IS_REPEATING Indicates if it is a repeating form.
IS_ROLLOVER Indicates whether the form contains a rollover type of question.
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.
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.
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.

Parent topic: Subject Form 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.
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.
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 on the record:
  • CREATED
  • MODIFIED
  • REMOVED
  • CLEARED

Note: For form records in skipped visits, OPERATION_TYPE is set to CLEARED.
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.

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.

Parent topic: Subject Form 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.

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 Form SVFL dataset

Reference folder

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

Data element Description

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.

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.
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 increases incrementally 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_WID

Indicates a subject's numeric identifier.

USER_WID

Indicates a user's numeric identifier.

Parent topic: Subject Form SVFL dataset