ABSTRACT

Site Evaluation Visits may also be known as site selection visits or pre-study site visits (PSSV). These visits may be conducted only by individuals at the level of MonitorIClinical Research Associate (CRA) or above. A Site Evaluation Visit is required unless someone from Company has conducted a visit to the site within the last 12 months for a study in the same therapeutic area or which utilizes the same Principal Investigator. In this case, a memo will be written and kept in the Central Study File documenting the date and purpose of the previous site visit.