Ⅰ期临床试验中生物样本管理的风险管控

Risk control of biological sample management in phaseⅠclinical trial

Ⅰ期临床试验项目中的生物样本具有数量庞大、管理集中等特点,所以需要更为专业的管理体系来保证生物样本的准确性、精确性。针对生物样本管理中的风险识别,在试验前和试验中做好规避风险的措施。研究中心不仅要培养研究人员专业技能和管理能力,而且应该增加其识别风险以及规避风险的能力,建立完整的风险管理体系,提高临床试验质量。

The biological samples in phase I clinical trials are characterized by a large number and centralized management,so a more professional management system is needed to ensure the accuracy of biological samples.For the risk identification in biological sample management,measures should be taken to avoid risks before and during trials.Research centers should not only train researchers’professional skills and management capabilities,but also increase their ability to identify and avoid risks,finally establishing a complete risk management system,and improving the quality of clinical trials.