Monitoring the Clinical Trial

The monitoring of clinical trials is an essential function for the smooth running of studies. The monitor or the clinical research assistant, in charge of this activity and a real link between the investigator and the sponsor, will have to ensure the respect of the subjects’ rights, the reliability and the traceability of the data generated, and to verify that the study is conducted in accordance with the protocol, good clinical practice (GCP) and applicable clinical regulation. Beyond these control objectives, monitoring is also a prevention tool to minimize or avoid potential problems during the study and to anticipate their too late identification, which could lead to more critical consequenceson the conformity of the study. The objective of this paper is to review the various stages of the monitoring and then to give practical tools that can be used at each of these stages. Keywords: Clinical Trial; Clinical Research Assistant; Coordinator; Good Clinical Practice