Data Integrity and Governance in Clinical Trials Informatics: Challenges and Solutions

Abstract

Data integrity and governance are paramount in clinical trials informatics, ensuring the reliability, accuracy, and trustworthiness of trial data. As the integration of informatics technologies advances, challenges arise in maintaining data integrity and adhering to robust governance practices. This paper examines the challenges associated with data integrity and governance in clinical trials informatics and proposes innovative solutions harnessing the power of informatics and AI/ML. Through a comprehensive literature review, case studies, and practical insights, this work addresses issues such as data quality assurance, regulatory compliance, participant engagement, and real-time monitoring. The proposed solutions encompass data validation techniques, privacy-preserving protocols, adaptive governance frameworks, and AI-driven anomaly detection. By identifying challenges and offering pragmatic solutions, this paper contributes to the enhancement of data integrity and governance standards, ultimately fostering the credibility and success of clinical trials in the informatics-driven era.