Overview of screening and enrollment

Subject registration is the process of screening candidates, enrolling them into an InForm study, and creating an electronic case report book (CRB) for them.

Screening and enrollment forms can vary from study to study. The basic registration forms required in all InForm studies include:

• Screening form —Use to capture subject initials, record basic candidate information, and indicate whether the candidate is eligible for the study.

  When you submit the Screening form, the candidate is added to the Screening Log.

• Enrollment form —Use to capture a subject number, record whether a screened candidate meets the enrollment criteria of the study, and complete the enrollment of the candidate.

  Note: If some information is not available when you begin the Enrollment form, you can enter partial enrollment data and submit the incomplete form. Then, at a later time, you can return to the form, complete the data, and submit the form again.

• Screening Log —Use to view the list of study subjects.

Note: If your study uses an IVRS system (Interactive Voice Response System) for subject screening and enrollment, the screening and enrollment forms may be automatically populated from that system.