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The process of configuring rollbacks

You can roll back a visit to a previous state. For more information, see Visit rollbacks defined.

Note: If a study threshold fluctuates and drops below threshold values more than once due to a rollback, the alert message is sent the first time the study drops below the threshold values. It is not sent again.

During rollback configuration, you complete each of these tasks:

  1. Authorize rollbacks for the study.

    This procedure switches on the ability for users of IRT for this study to roll back a visit to a previous state. If the visit you want to roll back to occurred several visits ago, you must roll back one visit at a time.

    You cannot roll back a screening visit.

  2. Identify specific properties and permissions for the rollback.

    For example, you can determine whether you want to roll back the drug status.

    You can also set the approval level for the rollback: no approval, one level of approval, or two levels of approval.

    A subject affected by a request for approval is locked (Locked subject) until the request is reviewed and either approved or rejected.

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