What Systems Do You Need to Know as a Clinical Trial Manager?

This. This video explores the five essential systems Clinical Trial Managers (CTMs) need to master for effective oversight of clinical trials: the Interactive Voice Response System (IVRS), Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) system, Lab Portal, and IRB Portal. The speaker, Tiffany Ashton, details how CTMs utilize each system to pull critical metrics, monitor study progress, ensure data quality, manage regulatory submissions, and support site operations. She emphasizes the importance of CTMs having direct access and proficiency in these systems to proactively manage trials, respond to sponsor inquiries, and maintain a pulse on overall study performance, from recruitment and data integrity to safety and regulatory compliance.

Key Takeaways:

• Multi-System Proficiency for CTMs: Clinical Trial Managers require hands-on familiarity with a suite of specialized systems (IVRS, CTMS, EDC, Lab Portal, IRB Portal) to effectively manage and monitor clinical trials.
• Data-Driven Oversight: Each system provides unique, critical data points—from patient recruitment and randomization metrics (IVRS) to monitoring reports and protocol deviations (CTMS), real-time source data (EDC), lab results and alerts (Lab Portal), and regulatory submission statuses (IRB Portal).
• Operational Efficiency & Reporting: CTMs leverage these systems to pull reports, track key performance indicators, respond to sponsor requests, and ensure timely communication, underscoring the need for efficient data access and reporting capabilities.
• Regulatory & Compliance Management: The video highlights the CTM's direct responsibility for managing central IRB submissions and tracking protocol deviations, emphasizing the critical role of these systems in maintaining regulatory compliance.ai to offer AI-powered solutions, data engineering, and business intelligence services to integrate, automate, and provide actionable insights from these crucial clinical trial data sources.