Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 26

To describe the nature and scope of controls that are in place to ensure that human biomedical clinical trials are conducted in a manner which ensures the protection of human subjects participating in them and the scientific integrity of the trial plan. Understanding the nature, scope and reach of the regulatory controls as well as their enforceability is essential to applying the GCP principles.