Screening and enrollment FAQs

How do I add a subject to a study?

Screen a candidate—Capture subject initials, record basic candidate information, and indicate whether the candidate is eligible for the study.
Enroll a screened candidate—Capture a subject number, record whether a screened candidate meets the enrollment criteria of the study, and complete the enrollment of the screened candidate. If you don’t have all the information, you can submit an incomplete form and complete it at a later time.

What if a subject fails screening?

Review the data and complete or correct it if necessary. Resubmit the candidate if you feel the candidate should be eligible. For more information, see Resubmitting a candidate who failed screening.

What if a subject fails enrollment?

Review the data and correct or complete it if necessary. If your study permits enrollment overrides, discuss the enrollment with a sponsor and determine whether the candidate can be enrolled. For more information, see Completing enrollment after an enrollment failure.