In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disruptions in menstrual cycles, violent episodes, or even deaths were not reported. While some cases were eventually identified, others went unnoticed, highlighting the importance of vigilant compliance. Sites should be aware that regulatory bodies like the FDA and DOJ closely monitor for such violations. 

Need assistance with your trial compliance? Reach out to Darshan at [email protected]. 

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