The Quality Working Party examines ethical, safety, and data oversight issues in clinical research. Its primary focus is on the work of the professional clinical trial auditor, with a view toward the regulatory and legal issues that distinguish this expertise. The Quality Working Party also looks at issues related to clinical trial monitoring and inspection. It is particularly concerned with the development of European standards for monitoring clinical trials, ethics committees, and sponsor-related responsibilities. It provides a framework for considering the impact and development of a European clinical trials inspection system within the context of sponsor, investigator, and ethics committee responsibilities