Clinical trials in today’s world are an expensive, complex multi-disciplinary process involving multiple stakeholders working together to comply with stringent regulations to improve patient lives by bringing innovative therapy to the market. There are multiple ways to achieve quality and compliance in clinical trials, but still, many CROs are struggling with quality concerns. Whenever regulatory authorities worldwide perform an audit, one of their most frequent findings is theinadequate performance of investigatingthe failure/deviations. The for-cause investigation is the advanced approach adopted by many organizations to find the root cause of failure and to design a way forward. Examples where cause investigation is required are failure to meet the expected outcome, failure to stop repeat observations, aberrant profile of drug, regulatory queries etc.