Regulatory Data Integrity in Decentralized Clinical Trials: A Technical Overview

This technical article examines the critical aspects of regulatory data integrity in Decentralized Clinical Trials (DCTs), exploring the challenges and innovative solutions in maintaining compliance while leveraging digital technologies. The article analyzes the integration of wearable devices, mobile applications, and remote monitoring tools, highlighting the complexities in data management and standardization across multiple platforms. It investigates the implementation of artificial intelligence, blockchain technology, and automated validation systems in ensuring data quality and regulatory compliance. The article presents comprehensive frameworks for managing diverse data streams, maintaining audit trails, and implementing quality control measures while addressing the evolving regulatory landscape. Through analysis of real-world implementations and emerging technologies, it provides insights into future trends and considerations for maintaining data integrity in the digital age of clinical research.