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The screening visit
Screening is the process of registering the subject in IRT. A screened subject has not yet been accepted in the study, but a record of the subject is logged in IRT in preparation for the next step in the visit schedule (typically, randomization).
During screening, IRT does the following:
- Registers the subject for this study in IRT.
- Assigns a screening number for the subject in IRT.
The screening number can be assigned by IRT, or you might enter it manually from a list of subject numbers provided to you at your site.
- Sets up the visit schedule for the subject in IRT.
- Adds the subject to the total count of screened subjects for the study that is maintained in IRT.
During the screening visit, you do the following:
- Log basic demographic information so you can accurately identify the subject at each visit. You log this information by responding to prompts, or questions, in IRT for the screening visit.
A request for approval is sent to the IRT approval system if:
- The subject does not meet the age requirements of the study (an out-of-age subject).
- The study is set up to use the IRT approval system.
- Confirm the information you have logged is correct.
When you complete the visit, IRT sends you an email confirmation as a record of the information you entered.
