Requesting an out-of-age approval

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. For more information, see Alternatives to screen failure.

Out-of-age visits might require approval. The subject's record is locked () until the approver makes a decision, and you cannot give the drug units to the subject until approval is received.

Screen the subject.
If the subject does not meet the required age limits for the study, IRT asks you if you want to continue.
Select Yes.
Complete the steps of the screening visit.

When you complete the screening, IRT sends you an email confirmation as a record of the information you entered and the request for an out-of-age approval.

You receive a second email when the approver has made a decision.