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강준봉(Jungbong Kang),우요섭(Yoseop Woo) 한국정보기술학회 2021 한국정보기술학회논문지 Vol.19 No.10
Clinical trials are very complex and lengthy processes that require compliance with procedures and regulations. Clinical trials are a very important process for facilitating the development of new drugs and improving outcomes and procedures that can lead to a better way of life for many patients. During the clinical trial study, the subject manually signs the consent or not on the document, but after the end of the clinical trial, it cannot be confirmed that the subjects research data will be used for other research purposes. Clinical trials have a structure in which it is difficult to quickly share information, and it is difficult to guarantee the transparency of clinical trial information and the reliability of the result value manipulation of original data. Since clinical trial data contains sensitive personal health information, it is very sensitive. We propose a management method using chain technology. Encryption application and components, distributed application functions, transaction headers and bodies were defined targeting biomarker data of multiple biosignals, and chaincode configuration and data inquiry experiments were performed in a distributed computing environment. By blockchainizing key data such as metadata in clinical trials, it was confirmed that there are strong advantages in privacy and security compared to the existing clinical trial data management system.