Golden Rules for Successful Monitoring

GCP rules demand that sponsors of clinical trials involving human drugs, biological products, medical devices, and combination products are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the integrity of the clinical trial data submitted to regulatory authorities. 

The presentation will discuss monitoring goals and considerations in monitoring planning. The advantages of applying risk-based approach to monitoring to increase efficeincies and produce cost savings while maintaining a high level of quality and compliance in clinical trials will finalize the presentation.