Data Monitoring and Management
This section focuses on monitoring and managing clinical trial data to ensure accuracy, completeness, and compliance throughout the trial.
- Data Monitoring: This topic discusses the ongoing monitoring of clinical trial data to detect and address issues, deviations, and trends.
- Risk-Based Monitoring: This topic explores the concept of risk-based monitoring and its implementation in clinical trials to optimize resource allocation and improve data quality.
- Adverse Event Reporting: This topic covers the reporting and management of adverse events and serious adverse events in clinical trials, including regulatory requirements and best practices.