Exploration And Discussions On The "Guidance For Industry Oversight Of Clinical Investigations—a Risk-based Approach To Monitoring"

On the August,2011, FDA (Food and Drug Administration) of the United States issued the " Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring". The guidance emphasized the great important of centralized monitoring to substitute the original one which was issued in1988and emphasized on the part of on-site monitoring to guide the sponsor and CRO (Contract Research Organization) in every aspect like formulated the SOP for clinical trials. This guidance is intended to assist sponsors of clinical trials in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data.With the high speed of the US medicine and technology development, FDA had more power in the global drug administration, so the guidance almost been the most important symbol of the global clinical trial monitoring. Meanwhile, US and other developed countries have encouraging risk-based monitoring approaches, and it will bring a new chapter in the clinical trial monitoring. So the study of the guidance is good for our clinical trial monitoring and the administration of new drug.My paper will study through the perspective of Pharmacy Administration, using the method of comparative analysis and logical antithesis and also doing a lot of tracking about the Internet News Information, to discuss the guidance and domestic policies, laws and regulations. Finally, my paper will give the suggestions on the clinical trial monitoring in our country.