Site Monitoring Visit Overview

The purpose of site monitor visits is to ensure compliance with study protocol, and standards for protection of human research subjects, and to ensure that all data are accurate and reliable.

• An initial site visit, also called a site initiation visit, should occur prior to subject enrollment. The monitor will review the protocol, implementation plan and delegation log with research staff.
• Visits happen on a periodic, reoccurring basis. Monitor visits require research staff to be available to answer questions. Staff do not need to be with the monitor at all times.
• The monitor will let research staff know the frequency of monitoring visits and the percentage of records to be reviewed each visit during the site initiation visit.

IMPORTANT: If the monitor asks a question during the visit and you do not know the answer, find the answer from the appropriate person and report back. It is ok to say that you do not know and will find out the answer.

Core(s): Regulatory Knowledge and Support