FDAnews Drug Daily Bulletin

An upcoming FDA final guidance on risk-based monitoring of clinical investigations will include more specifics for drugmakers on developing monitoring plans, as industry has requested. The final guidance will stipulate that plans should focus on the important and likely risks to critical data and processes, as identified by a risk assessment. It will also include specific tips on how to conduct a risk assessment and references to tools and methodologies to perform them.
Clinical Trials Advisor