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:
- 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.
- 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 () until the request is reviewed and either approved or rejected.