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Alternatives to screen failure
Out-of-age subjects are either younger or older than the age requirements for the study. A subject who does not meet these age requirements is often screen failed. However, instead of screen failing the subject and if the study permits, you can request approval for an out-of-age subject to continue in the study.
The sponsor can set up the screening process to respond to out-of-age subjects in one of these ways:
- IRT stops the screening process with a message that the subject is out of age and does not meet the requirements of the study.
You cannot complete the screening in IRT. If you are not sure of the next step, check with the field monitor.
- IRT advises you that the subject is out of age, and asks if you want to continue.
The subject must be approved to continue in the study. An email notification is sent to the approver. When the approver accepts or rejects the request, you receive an email with the decision.
When you complete the screening, IRT sends you an email confirmation as a record of the transaction.
