Principles of Good Clinical Practice

The design, monitoring, recording, analyzing, and reporting of clinical trials are major issues which need to be standardized all over the world. Accordingly, good clinical practice (GCP) is an international ethical and scientific quality standard for conducting the trials involving human subjects. In this chapter, a brief history of GCP, leading to its importance and functions, will be discussed. Then, we will go through some details about its principles and some major roles of components including the patients, sponsor, investigator, and other stakeholders. Before addressing the challenges which you will be faced with using the guidelines, there are some examples about different kinds of GCP guidelines around the world to show how it is implemented and influences the performance and management of clinical trials.