Clinical Study Preparation: Sponsor Support for the Quality of Site Management

Abstract

This paper provides an overview of the role of the sponsor in supporting and improving quality in the conduct of a trial through improved performance at the site. Critical issues reside in ensuring standardization of performance at all sites, hence homogeneous and unbiased results. Sponsor responsibilities in this process mainly include preparation of a feasible protocol, care in ensuring that personnel are qualified and trained, providing a communication and information network, and definition and enforcement of standards. A leading function is played by study monitors whose role is evolving into process-managers who are no longer confined to data verification. In such a context, the monitor’s careful analysis of microactivities at the site substantially facilitates implementation of a system aimed at preventing performance deficiencies and delays.

A key to success is commitment to the project by all involved parties, not only the company and the investigator, but also hospital staff, monitors, clinical research organization (CRO) personnel, and patients. The sponsor’s support in organizing and coordinating teams with different levels of responsibility, either managerial or operational, facilitates harmonized behavior, integrated communications, recognition of each mem-ber’s role, and ultimately improved global performance and quality.