ABSTRACT
The study sponsor is charged by the Food and Drug Administration (FDA) with the responsibility of monitoring the study’s progress and the site’s study activities [21 CFR 312.56 (a)]. Monitoring visits are usually performed by the sponsor’s representative, the Clinical Research Associate (CRA). Monitoring occurs through telephone communication, correspondence, and site visits. Site visits have differing purposes and agendas, depending on the stage of the study. This chapter will describe the qualifications, duties, and responsibilities of the CRA, investigator, subinvestigator, and Clinical Research Coordinator (CRC). Specific types of site visits are discussed in other chapters, and specific monitoring activities are discussed in Chapter 12.
