用于评估临床试验风险的方法

• Format: Patent
• Language: Chinese
• Published: 16.04.2021
• Subjects: CALCULATING; COMPUTING; COUNTING; DATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FORADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORYOR FORECASTING PURPOSES; HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATIONTECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING ORPROCESSING OF MEDICAL OR HEALTHCARE DATA; INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTEDFOR SPECIFIC APPLICATION FIELDS; PHYSICS; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE,COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTINGPURPOSES, NOT OTHERWISE PROVIDED FOR

本发明揭示了一种用于评估临床试验风险的方法，将采集获得的数据划分成为两种类别，即与受试者安全性关联的关键数据以及数据质量数据两个维度对临床试验参与医院进行风险评估。根据本申请的方法，能够将多种临床试验数据结合后进行风险量化以得到临床试验安全性风险分项指标数据、数据质量风险分项指标数据和临床试验参与医院的风险指标数据，根据临床试验风险等级调配监查人力资源精准的进入临床试验参与医院中。并以具体的安全性风险分项指标数据和数据质量风险分项指标数据为依据以监查各个组成的数据指标的风险程度，执行相应的监查工作达到实时的管控临床试验的目的，维护受试者权益提高临床试验质量。 The invention discloses a method for assessing the risk of a clinical test, and the method comprises the steps: dividing collected data into two categories, namely key data associated with the safety of a subject and data quality data, and carrying out the risk evaluation of a hospital participating in the clinical test. According to the method provided by the invention, various clinical test data can be combined and then risk quantification is carried out so as to obtain clinical test safety risk subitem index data, data quality risk subitem index data and risk index data of clinical test participation hospitals; and monitoring human resources are allocated according to the clinical test risk level to accurately enter a clinical t