5 Administering Clinical Subjects and Clinical Visits

This chapter covers administering clinical subjects and clinical visits. It includes the following topics:

• About Subject Visit Templates

• Process of Defining Subject Visit Templates

• Approving Subject Visit Templates

• About Automatic Tracking of Subject Status

• Creating Records for Clinical Subjects

• Scheduling Clinical Subjects

• Rescheduling Clinical Subjects

• Administering Subject Visits in Batch Mode

• Screening Clinical Subjects

• Rescreening Clinical Subjects

• Enrolling Clinical Subjects

• Randomizing Clinical Subjects

• Overriding Initial Subject Status

• Transferring Clinical Subjects

• Viewing Subject Transfer Information for Clinical Subjects and Sites

• Viewing Subject Visits Information for Sites

• Creating Unscheduled Subject Visits

• Terminating Clinical Trials Early for Clinical Subjects

• Applying Protocol Amendments to Sites and Clinical Subjects

• About Rolling Up Information for Subject Enrollment

• Viewing Status Accruals for Clinical Subjects of Sites

• Viewing Status Accruals for Clinical Subjects of Clinical Regions

• Viewing Status Accruals for Clinical Subjects of Clinical Protocols

• Monitoring Rates for Subject Enrollment

• Monitoring Status Accruals for Clinical Subjects by Visit Type

• Using Audit Trail for Changes to Subject Status

• Generating Oracle BI Publisher Reports for Site Enrollment Status

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