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

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

Tinatin Gogrichiani *

Senior Clinical Research Associate at ICON plc Georgia, Tbilisi.

Research Article

International Journal of Science and Research Archive, 2025, 14(01), 1642-1648

Article DOI: 10.30574/ijsra.2025.14.1.2627

DOI url: https://doi.org/10.30574/ijsra.2025.14.1.2627

Received on 20 November 2024; revised on 19 January 2025; accepted on 26 January 2025

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.

Data monitoring; Clinical trials; Risk-based monitoring; Digital technologies; Data management systems; Analytical platforms

https://journalijsra.com/sites/default/files/fulltext_pdf/IJSRA-2024-2627.pdf

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Tinatin Gogrichiani. Organization of the data monitoring process within the framework of clinical trials. International Journal of Science and Research Archive, 2025, 14(01), 1642-1648. Article DOI: https://doi.org/10.30574/ijsra.2025.14.1.2627.

Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0

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