HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)

Clinical research is necessary to establish the safety and effectiveness of specifi c health and medical products and practices. Much of what is known today about the safety and effi cacy of specifi c products and treatments has come from randomized controlled clinical trials1 that are designed to answer important scientifi c and health care questions. Randomized controlled trials form the foundation for “evidence-based medicine”, but such research can be relied upon
only if it is conducted according to principles and standards collectively referred to as “Good Clinical Research Practice” (GCP).