Organization of the data monitoring process within the framework of clinical trials

Gogrichiani, Tinatin (2025) Organization of the data monitoring process within the framework of clinical trials. International Journal of Science and Research Archive, 14 (1). pp. 1642-1648. ISSN 25828185

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Abstract

This article explores innovative methodologies for organizing the data monitoring process in clinical trials, with a focus on traditional, remote, and risk-based approaches, as well as the integration of digital technologies. Through a comparative analysis of monitoring models, the study highlights the advantages of combining these methods in multicenter projects to enhance data accuracy, security, and compliance with modern regulatory standards. The findings demonstrate that digitalization and centralized systems significantly improve monitoring efficiency and risk management, offering actionable recommendations for clinical researchers and project managers. The materials of the article are based on a comparison of different monitoring models. Their application in multicenter projects is being considered, and their compliance with modern regulatory requirements is being assessed. Special attention is paid to the stages of planning, execution, completion of monitoring, as well as the introduction of information technologies. The possibilities of using data management systems. The results confirm that the combination of methods using elements of digitalization helps to increase the efficiency of data analysis, and minimizes the risks that arise in the process of processing large amounts of information. Ensuring data security and adapting monitoring to the specifics of specific projects is of particular importance. This work is of interest to researchers, clinical project managers, and specialists involved in the development of digital solutions. The proposed recommendations are aimed at introducing relevant approaches that meet the requirements of modern science. Data monitoring remains an important element of clinical research. To achieve these goals, it is necessary to use methods that combine traditional practices and innovative solutions aimed at improving management and data processing technologies.

Item Type: Article
Uncontrolled Keywords: Data monitoring; Clinical trials; Risk-based monitoring; Digital technologies; Data management systems; Analytical platforms
Subjects: H Social Sciences > HA Statistics
Q Science > Q Science (General)
Q Science > QA Mathematics > QA76 Computer software
Depositing User: Editor IJSRA
Date Deposited: 08 Jul 2025 16:54
Last Modified: 08 Jul 2025 16:54
URI: https://eprint.scholarsrepository.com/id/eprint/160

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