Ensuring Quality in Clinical Research: The Impact of Quality Assurance and Quality Control in the Field of Good Clinical Practice

Abstract

Good Clinical Practice (GCP) compliance delivers assurance that the study participants' safety is protected and that the obtained data are legitimate and credible. One of the tools to obtain quality in clinical research is to assure robust quality assurance and quality control as part of the quality management system. This is considered essential for sponsors to assure that the data from the clinical trial have integrity and reliability. One of the purposes of this article was to provide information to allow clinical research, quality assurance professionals, academics, and members of ethics committees to stay up to date with clinical research and good practice developments. This article investigates the enormous value of quality assurance and control in clinical trials, highlighting their pivotal role in ensuring the integrity, safety, and efficacy of research findings.