Introduction
With the clinical trials becoming more complex and demanding, it is necessary to review current practices and optimize processes to ensure that quality is not compromised. Aware of this need, the International Conference on Harmonisation (ICH) revised the first version of Good Clinical Practice (GCP) guidelines to encourage implementation of improved and more efficient approaches to clinical trial conduct. In result, risk management is pointed out as an opportunity to accomplish this objective and it has been identified as the sole responsibility of the sponsors.1–4
Risk management, like any methodology for ensuring the quality of clinical trials, is a shared responsibility of all stakeholders.5 In fact, over the last two decades, there has been a growing concern with quality and efficiency in this field. Sponsors, especially industry sponsors, have intensified the risk culture implementation, for example, through the implementation of risk-based monitoring methodologies.6–8 Regulatory authorities have also taken some steps in the mindset change from a conservative approach, with the objective of ensuring zero defects, to a risk-based approach by which areas of greatest risk…
