Clinical Data Management: A Regulatory Perspective

Abstract

This article offers a comprehensive overview of clinical data management through a regulatory lens, underscoring the vital role of global regulatory standards in upholding data quality, integrity, and patient safety in clinical trials. It examines key regulatory guidelines issued by agencies such as the FDA, EMA, and ICH, as well as data privacy laws like GDPR and HIPAA. The article delves into best practices for achieving and maintaining regulatory compliance in CDM, addressing the challenges and complexities involved. Furthermore, it explores the impact of emerging technologies on regulatory compliance, providing insights into future regulatory trends and their implications for clinical research.