New data element to track visit, form, and item level locks

With the new data element added to multiple datasets in Oracle Clinical One Analytics, data managers can now create enhanced reports and include information about the current lock status for visits, forms, and questions.

A new data element called LOCKED is now available in the following datasets:

• Blinded Subject Events dataset
• Unblinded Subject Events dataset
• Subject Forms dataset
• Subject Form Items dataset

Depending on the dataset being used, this data element reflects the status of an event or visit, a form, or a question.

Note:

There is no LOCKED status for the entire subject that is tracked in Oracle Clinical One Analytics as part of this enhancement.

You can use this data element to track the current lock status of a given object (visit, form, or question). Regardless of the type of object you are analyzing, this data element can have the following lock status values:

Lock status	Description
<null>	No lock has ever been applied to this object.
LOCKED	All objects within the visit, form, or question have been locked.
UNLOCKED	The object has no locks applied after being locked at one point in the past. Note: Event or visit locking applies to the entire visit, including the Visit Date. For a visit to be marked as LOCKED, the Visit Date and all associated objects must be locked. If the Visit Date is not locked, the visit cannot be locked.

The data about the lock status will be loaded in Oracle Clinical One Analytics for the full audit history. This means that when past records of an item or form are retrieved, the lock status that the given item or form had at that time will be reflected for it.

Tip:

If you want to work with the audit history of lock actions for a given visit, form, or question, check out the New datasets to track sign, verify, freeze, and lock actions, also introduced in this release.

You can find additional information regarding these datasets and the new LOCKED data element, in the Analytics User Guide after the Release Assessment Environment (RAE) upgrade.