ABSTRACT
In a clinical trial, the monitor's responsibilities are many and varied. A succinct description of the duties of monitors is that they oversee all aspects of the study and are the principal link between the sponsor and the study investigator or study director if several associate investigators are involved. 1be monitor should have a scientific background sufficient to understand the technical aspects of the protocol, understand data collection and auditing procedures and be fully conversant with the principles of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). A vital component of the monitor's role in a clinical study is to maintain a complete record of all contacts by telephone, visits, letters, faxes and emails with investigators, the sponsor or any other relevant personnel concerning the design, conduct, documentation and reporting of the study.
