The role of electronic data capture systems in clinical trials: Streamlining data integrity and improving compliance with FDA and ICH/GCP guidelines

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.