临床研究数据安全等级划分的初步探索

Preliminary exploration of the classification of data security in clinical research

目的针对临床研究数据特征,构建面向真实世界研究的临床研究数据安全等级划分策略。方法以相关法规要求为依据,参考相关领域的安全性等级划分策略初步将临床研究数据划分为五个安全等级。进而遴选参与临床研究过程,且具有丰富经验的临床医学、临床研究方法学、临床研究管理、伦理学、遗传学以及公共卫生数据应用与管理专家,采用三轮德尔菲法咨询专家意见。结果经过专家咨询及逐轮次修订,专家意见渐趋一致。最终将临床研究数据共划分为五个安全性等级并明确了各等级相应的数据属性和安全策略。其中共包括数据类别33项,涵盖临床研究可能涉及的人口学信息,临床检查、诊断、治疗信息,遗传信息,卫生经济学信息以及研究可能涉及的已经公开发表的医学数据和研究过程信息。结论在临床研究数据规模日益扩大的应用背景下,实现数据安全等级划分及管理是保障数据安全,实现合理利用的必要措施。针对临床研究数据,本文所提出的临床研究数据安全等级划分策略可以为今后进一步完善数据安全策略提供有益参考。

Objective To construct a strategy for classification of clinical research data security for real-world research,based on the features of clinical research data.Methods Based on the laws,regulations,and data security classification method in relevant fields,the clinical research data was classified into five security levels.Then,the method was gradually perfected through three times of revisions,which followed the advice from experts who were experienced in many relative areas,such as clinical medicine,clinical research methodology,clinical research management,ethics,genetics and public health data application and management.Results Experts’opinions gradually converged through several times of consultation.The clinical research data was finally classified into five security levels with explicit definition and security policy for each security level.Thirty-three data categories,which covered demographic information,clinical examination,diagnosis,treatment information,genetic information,health economics information,medical data and information on research processes that have been published,were included in the five security levels.Conclusions Since there is an increasing trend of data scale and the data security classification and management are necessary to ensure the data security and appropriately utilization of data.The method of clinical research data classification proposed in this paper can provide beneficial references for the further improvement of data security in the future.