Audit Folder

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

Table 3-81 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.

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.