Data Integrity and Security in Clinical Trials: A Comprehensive Approach

Authors

  • Douglas Christian, Keith Austin Department of Engineering, Liberty University

Keywords:

Clinical Trials, Data Integrity, Data Security, Regulatory Compliance, Electronic Data Capture (EDC), Blockchain in Clinical Trials, Data Encryption, Patient Privacy

Abstract

Clinical trials represent a critical phase in the development of medical interventions, demanding the utmost attention to data integrity and security. This paper explores a comprehensive approach to safeguarding data throughout the clinical trial lifecycle. From data collection to analysis and reporting, the intricate interplay of regulatory compliance, technological solutions, and ethical considerations is examined. By addressing challenges and proposing proactive strategies, this work aims to guide researchers, sponsors, and regulatory bodies toward ensuring the integrity, confidentiality, and reliability of clinical trial data.

Downloads

Published

2023-12-30