Randomized controlled trials(RCTs)provide optimal evidence of the effectiveness and safety of a new drug,a new medical device,or a new therapeutic strategy with the necessary scientific design[1].Traditional electroni...Randomized controlled trials(RCTs)provide optimal evidence of the effectiveness and safety of a new drug,a new medical device,or a new therapeutic strategy with the necessary scientific design[1].Traditional electronic data collection(EDC)systems for clinical trials primarily focus on data entry,validation,and compliance monitoring.However,their reliance on centralized architectures introduces vulnerabilities in data security and integrity。展开更多
基金supported by the National Natural Science Foundation of China(92368205 and 82301265)the Guangdong Provincial Natural Science Foundation for Progressive Young Scholars(2023A1515030170)+3 种基金the Science and Technology Planning Projects of Guangdong Province(2018B010109008)the Science and Technology Planning Project of the Guangzhou Municipal Health Commission(2024A031004)the Basic Scientific Research Projects of Sun Yat-sen University(23ykcxqt002)the China Postdoctoral Science Foundation(2023M734047).
文摘Randomized controlled trials(RCTs)provide optimal evidence of the effectiveness and safety of a new drug,a new medical device,or a new therapeutic strategy with the necessary scientific design[1].Traditional electronic data collection(EDC)systems for clinical trials primarily focus on data entry,validation,and compliance monitoring.However,their reliance on centralized architectures introduces vulnerabilities in data security and integrity。