临床试验信息化平台在伦理跟踪审查中的作用

Role of Clinical Trial Information Platform in Ethical Continuing Review

伦理审查贯穿临床试验全过程。即使获得伦理委员会初始审查批准的临床试验研究项目,在实施过程中仍可能出现各种问题,而伦理委员会跟踪审查有助于降低临床试验实施过程中受试者可能面临的风险。目前伦理跟踪审查尚未引起足够重视,该文分析伦理跟踪审查过程中存在的问题,如主动性和及时性不足、伦理审查报告不规范、法规政策不完善等,结合临床试验信息化平台建设,对伦理跟踪审查面临的问题提出解决措施,以期使伦理跟踪审查工作真正做到及时、有效和优质,从而最终提升临床试验研究质量,更大程度保护受试者安全和权益。

The ethical review should commit throughout the whole process of clinical trials.Even the clinical trials which approved by the ethics committee initial review may still have a variety of problems in the process of implement,the continuing review of the ethics committee will help to reduce the risk of implementation process.The ethical continuing review still has many deficiencies,such as initiative and lack of timeliness,ethical review reportis not standard,the regulations and policies are insufficient,etc.Combination with the construction of information platform for clinical trials,we tried to putforward the solving measures for the ethical continuing review,which expect to make ethical continuing review work truly timely,effective and high quality,in order to improve the quality of clinical trials,and to protect the safety and rights of the subjects.