Clinical oversight is a methodology intended to assist sponsors of clinical investigations in developing strategies and plans for investigational studies of medical products, including human drug, biological products and medical devices to ensure human subject protection, data integrity and regulatory compliance.
It focuses on proactive risk management in clinical research and helps in completing clinical trials successfully within the timelines and budget. Applying Quality Risk Management (QRM) principles to clinical research from the early stages of drug development can expedite the process of bringing quality drugs from bench to market, addressing regulatory challenges and patient safety.
Quality risk management guidelines were established for GMP and medical devices. However, there were no guidelines available on handling of risk in clinical trials. The aim of clinical oversight methodology is to provide guidance on handling of risk in clinical trials. It is a holistic approach to clinical quality management that incorporates risk management principles of ICH Q8 and ICH Q9. It helps in identifying critical activities and potential risks involved in clinical trial conduct, which reduce or eliminate the risks and minimize the likelihood of errors and prevent their re occurrence.
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