生物等效性和生物利用度杂志

抽象的

Impacts and Implications of Risk Based Monitoring: A CRO Perspective

Prashant A. Pandya

During the past decades, the complexity of clinical trials has grown dramatically due to geographic dispersion, site related issues, treatment choices, standard of care and regulatory uncertainty. The uncertainty have created opportunity for the Risk Based Monitoring (RBM) / centralize monitoring due to use of electronic system, changes in statistical assessment, improvement in clinical trial documents. RBM has emerged as the future of clinical development. This approach is supported by the US-FDA, European Medicines Agency (EMA) and several other regulatory agencies.

Fabrication of data, fraud, data distribution errors and other data anomalies that can be readily found by risk-based monitoring policies and procedures. RBM improves quality and efficiency of sponsor to oversight clinical sites and help to save significant cost. It helps to quickly identify signals that could affect quality and operational performance. It is concluded that, efficient planning lays the foundation of an effective risk-based monitoring strategy.