Objectives of QC systems and QA function in clinical research.

Over the recent years, the concept of Good Clinical Practice (GCP) has rapidly evolved over the world, with guidelines and regulations now existing not only in the U.S.A. but also in Europe, Scandinavia, Japan, and Australia. The systematic measures laid down in GCP are to ensure that clinical studies are conducted in conformity with strict ethical rules, are performed according to high-quality standards, and result in authentic, verifiable scientific data. Different aspects in managing quality in the clinical field are to be presented: (1) The definition of a two-stage quality system: it identifies the differences between quality control activities which reside with the operational units and auditing activities performed by an independent Quality Assurance group, which assesses the efficiency and integrity of the control systems established to ensure the quality. (2) The multidisciplinary picture of a clinical study: every operational staff contributes to quality through a chain using the "quality in/quality out" concept. (3) The review of the main responsibilities of the main professionals (Sponsor, Monitor, and Investigator) in a GCP environment, to show that quality is achievable by involving appropriate qualified staff. (4) The need of proactive control systems to reduce the risk of error and increase the credibility and confidence in building quality. (5) The role and objectives of a Quality Assurance Group.