目前,作为一种相对特殊的医疗诊断药品,体外诊断试剂在医学领域的科研和临床试验的应用已经越来越普遍。然而,由于有关监管预防措施的不健全及相关法规执行力度不强,导致医院在对体外诊断试剂进行管理时,存在各方面的漏洞和问题。所以要保证体外诊断试剂的有效管理与质量安全控制,使其能够更好地确保医院临床试验结果的精确性、科学性。 At present, as a relatively special medical diagnostic drugs, in vitro diagnostic reagents in the field of medical research and clinical trials has become increasingly common. However, the inadequacies of regulatory precautions and the lack of implementation of relevant laws and regulations have led to various loopholes and problems in the management of in vitro diagnostic reagents at hospitals. So to ensure the effective management of in vitro diagnostic reagents and quality and safety control, making it better to ensure the accuracy of the hospital clinical trial results, scientific.