Whitepaper

Effective monitoring of clinical trial is critical to protection of human subject as well as high quality credible data. Traditionally, it was believed that Regulators like US Food and Drug Administration (FDA)   and European Medicines Agency (EMA) insist on 100% source‐document verification (SDV) through on‐site monitoring. However, recent guidance like FDA draft guidance on Oversight of Clinical Investigations — A Risk‐Based Approach to Monitoring issued in August 2011 and EMA Reflection Paper on risk based quality management in clinical trials issued around same time have altered the widespread impression on Regulators expectation, opened the path for a flexible risk‐based monitoring approach through implementation of risk‐based study specific strategies with a balance of remote and onsite monitoring  aimed at maximizing monitoring effectiveness with judicious use of resources