Visit rollbacks

A rollback restores the information gathered during a visit to a previous state—typically, to the last fully correct version of data for the subject. Typical purposes of a rollback are to:

Delete a transaction for the wrong subject.
Re-do a visit with incorrect information that might affect the outcome of the visit.

Note: You cannot roll back a screening visit.

To roll back more than one visit, you must roll back one visit at a time. For example, consider the following scenario:

Visit Schedule	Notes
Screening
Randomization
Visit 2	Desired state of data
Visit 4
Visit 6	Current visit (with incorrect data)

In this situation, you must roll back:

Visit 6 to Visit 4
Visit 4 to Visit 2

When you request a rollback, you do the following:

Select the date of the visit containing the incorrect information.
Provide a reason for the rollback.
Provide the date by which you need the approval (for example, the day before the subject's next visit).
Verify, for each drug unit provided to the subject, that the supplies never left the possession of the site (if the rollback allows the drug status to be rolled back).

When you submit the rollback, IRT sends a notice to the approvers that a rollback has been requested. IRT also sends you an email confirmation of the request.

Perform a rollback as soon as you discover the error. Errors in visit information can have a large impact: the integrity of study data, the health of the subject, and the ability to conduct the next visit. It is critical that these errors be corrected immediately.
IRT cannot assign drug supplies to the subject during a lock. Since you cannot give drug supplies to the subject until they have been assigned, it is critical to request the approval for a rollback as soon as possible to make sure the subject is unlocked by the next visit.