The Study On The Security Of Clinical Trials And Good Clinical Practice

At present, the medicine Clinical Trials is an important link of researching and developing the course of new medicine, is key effect appraised finally to the security and validity of the new medicine to go on the market, through the human Clinical Trials to appraise security and validity of the new medicine, to supply important evidence for appraise and approval of the new medicine. Guarantee the security of the medicine Clinical Trials and protect experimenter's right have already become one of the important contents that Clinical Trials. No matter traditional Chinese medicine than Western medicine, FDA, ICH, EMEA, and SFDA of our country are extremely paid attention to guaranteeing the medicine Clinical Trials security.Good Clinical Practice there are two cores that: First, the security, second, the scientific. It is the legal basis of ensuring the medicine Clinical Trials security effectively to carry out and implement GCP, and essential to ensuring experimenter's life and health.This text passes the content and demand of the introduction medicine with phased Clinical Trials at first, points out the medicine Clinical Trials security question runs through the whole Clinical Trials all the time, and then carried on detailed analysis to GCP. Pointed out that influences the question of the Clinical Trials security of medicine of our country at present, whether propose from to how carry out and implement to question these GCP guarantee Clinical Trials security go on the discussion effectively following seven respects.1. Training and preparation before the Clinical Trials;2. The choosing of the medicine clinical research hospital;3. Make SOP;4. Monitoring of the adverse event;5. Management of the study files; 6. Management of the investigational agent;7. CRO, to ensuring and improving the function of Clinical Trials quality.