Screen failures (after screening)
A subject can be screen failed if that person does not meet the requirements of the study—for example, the subject does not pass the medical screening.
If the subject does not meet the age requirements of the study, you might be able to request an out-of-age approval during screening as an alternative to screen failure.
When you screen fail the subject, IRT does the following:
- Removes the visit schedule from the subject's record to prevent additional visits from being logged for this subject.
- Adds the subject to the total count of screen failures for the study.
During the screen failure process, you do the following:
- Check to make sure the subject was registered in IRT during screening. If a subject must be screen failed but has not been registered in IRT, you must create a screening visit before you can log the screen failure.
- When you screen fail the subject, IRT steps you through a series of prompts to verify the identity of the subject. Check the information in IRT against the source record to make sure you are screen failing the right person.
When you complete the screen failure, IRT sends you an email confirmation as a record of the transaction.