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The process of configuring out-of-age approvals

An out-of-age approval request is a request for a subject who does not meet the study age requirements to continue in the study. If these approvals are authorized for the study, a request for approval is automatically sent to the approval system when an out-of-age subject is screened. The age is calculated from the date of birth.

During configuration, you complete each of these tasks:

  1. Authorize and configure out-of-age approvals during study design, if requested by the sponsor.

    An Oracle representative must perform this task. This task switches on out-of-age approvals for the study.

  2. Set the approver permissions for out-of-age visits.

    You can set none or one level of approval for out-of-age visits. Set the approval by assigning a role to the out-of-age approval function on the Manage Permissions page.

    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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