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 Source Data Verification (SDV), either for the entire study, by subject or by site.
  • The percentage of forms items with a status of Incomplete, Completed, Frozen, SDV Complete, Signed or locked by either country, site, subject, and visit.
  • 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 Clinical One Cloud Service, 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 3-61 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.

Parent topic: Subject Form Items 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.

Table 3-62 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.

Parent topic: Subject Form Items dataset

Country folder

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

Table 3-63 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.

Parent topic: Subject Form Items dataset

Subject folder

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

Table 3-64 Data elements in the Subject folder

Data element Description
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.
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 3-65 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 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.

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.
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..

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 Clinical One Cloud Service.

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

Table 3-66 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 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).
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 3-67 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).
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.
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.
HAS_QUERY Indicates if there is a query raised against a question, irrespective of the status.
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 Clinical One Cloud Service converted to the question data type as per form design.

Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces).

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 Clinical One Cloud Service 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.
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.
LOCKED Indicates the lock status of the given question. This field can have the following values:
  • <null>: No lock has ever been applied to this question.
  • LOCKED: The question is currently locked.
  • UNLOCKED: The question has no locks applied after being locked at one point in the past.
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 numeric 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. For example:|
  • Text
  • Number
  • Age
  • Date/time
  • Drop-down
  • Radio buttons
  • Checkboxes
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.
SDV_SELECTION_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.
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).

Parent topic: Subject Form Items dataset

Audit folder

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

Table 3-68 Data elements 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.
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.
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.
DATA_EVENT_TYPE Indicates the type of event in the data-change lifecycle. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL.

Parent topic: Subject Form Items 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

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.
FORM_WID

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

A number that represents the form item, as a unique identifier within the study.
PARENT_WID

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

A sentinel value of -1 can appear when no parent record applies.
ROOT_WID

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

A sentinel value of -1 can appear when no parent record applies.
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_EVENTINST_FORM_WID

A number that represents a subject form associated with a specific visit instance, as a unique identifier within the study.
SUBJECT_EVENTINST_FORMITEM_WID

A number that represents an item within a subject form associated with a specific visit 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.

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.

Parent topic: Subject Form Items dataset