[Quality assurance in clinical studies: a necessity].

Abstract

Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) are the constituents of a new concept for quality assurance in pharmaceutical research. They are to establish standards for preclinical and experimental research in animals (GLP), for the manufacturing of drugs (GMP), and for trials on medical products in human beings (GCP), respectively. Each of the 3 entities is characterized by the same principles of control; these involve written instruction describing the general operations to be performed, the so called Standard Operating Procedures (SOP), and Quality Assurance Units being responsible for surveying the operations in accordance with the SOP, and ensuring that the generated data will satisfy the requirements for quality. As far as clinical trials are concerned, the SOP is represented by the study protocol and a Monitor provides for the surveying of the trial. GCP is further characterized by ethical principles, which aim primarily at protecting personal integrity and welfare of the trial subjects. The Declaration of Helsinki is the accepted basis for clinical trial ethics. Following the Declaration of Helsinki during the planning, conducting, surveying and evaluating of clinical trials provides for a degree of seriousness being the real hallmark of Good Clinical Practice.