ABSTRACT
This chapter presents an overview of the role and responsibilities of the contract research organization in clinical research. Increased regulatory requirements and increased complexities of human clinical research have taxed industry resources and have broadened the role of the contract research organization and the clinical trials professional. The contract researcher should provide specific assurances that mechanisms are in place to provide sufficient experience and expertise, volunteer availability, staff availability, valid procedures and associated documentation, and standardized and certified clinical instruments and equipment, so as to allow the project to move along quickly. Evaluation of the experience of the research unit and the professional history of the principal investigator(s) should provide estimates of the ability of the contract organization to meet compliance requirements and of the worth and prevalence of systems designed to address these requirements. The principal investigator, associate investigators, and clinical trials professionals typically oversee the operations of the contract research organization.
