Monitoring is a quality control measure put in place to ensure that subject’s safety, well-being and rights are protected, collected data is completed, accurate and verifiable and the study is conducted according to the protocol, GCP and local requirements. Therefore, Site Monitoring Visits (SMVs) are performed frequently during the clinical trial. The purpose is not only to verify site’s activities but also to support the site and make sure all needed supplies are in place. Course introduction to the Site Monitoring Visits provides the general understanding of the monitoring process. By attending the course, participants will learn the definition and purpose of the SMV, key aspects of the SMV, how to plan, prepare, conduct and follow-up the SMV. Participants will understand what kind of documents and SOPs are related with the SMV. During the course participants will get familiar with the real-life example. After completion of the course, obtained knowledge can be verified by taking the bank of questions. Participants also have possibility to take practical exercises to find a real-life application of a theoretical concept.