ABSTRACT
The monitoring process, project management, is a fairly, and essential, addition to this pursuit. In practice, the monitoring process is a specialized management method or system by which the monitoring team regulates, adjusts, and controls the sequence of drug studies for the purpose of developing a data base that will scientifically document the basic properties and clinical usefulness of the drug under study. The monitoring process begins during the preclinical phase of drug development and continues into the postmarketing phase of the drug's life cycle, as long as the sponsor continues to collect drug-related experiences and information. The monitoring process is essential to fulfilling that objective; it is the glue that bonds the many elements of the scientific drug research process together. Although members of the monitoring team are usually involved in the planning step, the monitoring process is viewed as starting at the implementation step.
