Advanced Clinical Trials and Clinical Research

Data Integrity & Compliance

Maintaining data integrity and compliance is fundamental to the credibility of clinical research. This session examines key principles and regulations governing data quality, including ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete) standards, 21 CFR Part 11, and GxP guidelines. Attendees will learn how to design compliant workflows, conduct data audits, and implement role-based access controls to protect sensitive information. The session discusses common data integrity risks—such as transcription errors, unauthorized edits, and system malfunctions—and presents mitigation strategies through validation protocols and monitoring plans. Case studies from sponsor and CRO perspectives highlight real-world data integrity breaches and regulatory outcomes. By the end of the session, participants will understand how to build a culture of quality, foster accountability, and align operational practices with evolving global regulatory expectations.