ABSTRACT

Each site contact requires specific monitoring techniques, including on-site monitoring visits, telephone contacts, written correspondences, and investigator meetings. Each contact must be documented to provide a written record of the contact and decisions made. There are four types of monitoring visits: prestudy, initiation, periodic, and study termination; some of these specific types of visits are discussed in detail in other chapters. This chapter will discuss the periodic site visit and the specific processes that should occur during any monitoring of a clinical trial.