Enhancements to the Subject Forms dataset

Oracle Clinical One Analytics now contains more comprehensive Audit folder details for forms that are in a SCHEDULED status. New data elements have also been introduced for better audit trails.

Full audit details for SCHEDULED forms

Forms that are not yet In Progress are included in the Subject Forms dataset as SCHEDULED form records. Such records are created based on the expected forms from the study design and visit schedule.

Previously, these records did not include details such as VERSION_START or VERSION_END in the Audit folder, as these records were not part of the subject's captured data.

Note:

VERSION_START indicates the first timestamp in the system where it is known that a subject should be completing that form. For dynamic forms, this would be when the form is triggered. For forms in scheduled visits, this matches the audit information of the visit containing the form.

New audit data elements for the Forms folder

Additionally, for better audit trails, the following data elements have been introduced in the Form folder:

Note:

These two elements provide additional context for the current record with the latest revision (IS_CURRENT=Y or VERSION_END = 31-12-3099) but cannot be used to investigate modifications that occurred in the past. The values contained in these data elements change independently of form status versioning.

Data element	Type of change	Description
LAST_UPDATED_DATE	New element	This new element provides the time of the most recent clinical data change within a particular form. This includes entering data, clearing data, or restoring data. If no clinical data has been entered in a form, this data element displays a value of null. Note: Data contained within this element does not change as a result of Sign, Freeze, Verify, and Lock (SVFL) actions, nor does it change as a result of form associations or site transfers.
LAST_UPDATED_BY	New element	Whenever a user performs a clinical data change that triggers a change in the data stored in LAST_UPDATED_DATE, the user's information is stored in LAST_UPDATED_BY.

You can find additional information regarding this dataset and its data elements in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade.