2019/02/11 by Olivia Choudhury, Choudhury, Olivia, Noor Fairoza +5
Computer Science · Medicine · #Blockchain Technology Applications and Security #Computers and Society (cs.CY) #Databases (cs.DB) #Ethics in Clinical Research #FOS: Computer and information sciences #Pharmaceutical Quality and Counterfeiting
paper · pdf · doi:10.48550/arxiv.1902.03975
openalex publication_date 2019/02/11 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/28
The cost of conducting multi-site clinical trials has significantly increased over time, with site monitoring, data management, and amendments being key drivers. Clinical trial data management approaches typically rely on a central database, and require manual efforts to encode and maintain data capture and reporting requirements. To reduce the administrative burden, time, and effort of ensuring data integrity and privacy in multi-site trials, we propose a novel data management framework based on permissioned blockchain technology. We demonstrate how our framework, which uses smart contracts and private channels, enables confidential data communication, protocol enforcement, and and an automated audit trail. We compare this framework with the traditional data management approach and evaluate its effectiveness in satisfying the major requirements of multi-site clinical trials. We show that our framework ensures enforcement of IRB-related regulatory requirements across multiple sites and stakeholders.