The role of electronic data capture systems in clinical trials: Streamlining data integrity and improving compliance with FDA and ICH/GCP guidelines
Independent Researcher, Texas, USA.
Review
World Journal of Biology Pharmacy and Health Sciences, 2024, 20(01), 321–334.
Article DOI: 10.30574/wjbphs.2024.20.1.0789
Publication history:
Received on 03 September 2024; revised on 13 October 2024; accepted on 15 October 2024
Abstract:
This study investigates the transformative role of Electronic Data Capture (EDC) systems in clinical trials, emphasizing their impact on data integrity, compliance with regulatory standards, and the efficiency of trial processes. The purpose of the research was to critically analyze how EDC systems align with FDA and ICH/GCP guidelines, addressing the complexities of modern clinical trials. By conducting a detailed literature review, the study explores the benefits, challenges, and technological advancements associated with EDC systems. Key findings highlight the significant advantages of EDC systems in enhancing data accuracy, real-time monitoring, and facilitating regulatory compliance through secure data management and audit trails. The study also identifies several challenges, including high implementation costs, data privacy concerns, and integration issues with other digital trial technologies. Technological advancements, such as artificial intelligence, blockchain, and decentralized trial models, are explored as promising solutions to these limitations, offering new avenues for optimizing clinical trial management. The study concludes that EDC systems have revolutionized clinical trials, streamlining data collection and analysis while ensuring compliance with stringent regulatory requirements. It recommends continued investment in EDC technologies, enhanced training for trial staff, and the integration of cutting-edge innovations to ensure future clinical trials' success.
Keywords:
Electronic Data Capture; Clinical Trials; Data Integrity; FDA Compliance; ICH/GCP Guidelines; Decentralized Trials
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Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0