Data Integrity and Secure Clinical Research Documentation
Introduction In clinical research, data is everything. From patient records to trial results, accurate and secure documentation underpins regulatory approval, ethical compliance, and public trust. Any compromise—whether accidental or intentional—can derail years of work. That’s why data integrity and secure documentation training is essential for clinical researchers, data managers, and sponsors involved in pharmaceutical, biotech, or academic trials. Why Data Integrity Matters in Research Clinical data guides decisions that affect human health and safety. Compromised data can result in: Invalid study results Regulatory rejection by authorities like the FDA, EMA, or DCGI Ethical violations affecting patient rights Legal consequences and reputational loss for sponsors or institutions Training ensures all staff understand how to handle research data with transparency, consistency, and accountability. Core Principles of Data Integrity (ALCOA+) Training programs follow the ALCOA+ framework...