Monitoring Visit in Clinical Research

Preparation, conduction and follow-up

By: Clinical Research Tools, Elisa Serpillo

Narrated by: Virtual Voice

The book offers a practical and detailed approach to all key phases of the visit: from initial preparation to on-site management, to closure and final follow-up.

Through best practices and operational strategies, the CRA will learn to:

1. Plan a monitoring visit effectively, optimizing time at the center.
2. Verify source data (SDV) and check the compliance of the experimental center with the protocol and GCP regulations.
3. Identify and manage deviations, adverse events and criticalities proactively.
4. Draw up clear and structured monitoring reports to ensure effective follow-up.
5. Use tools and technologies to improve the quality and efficiency of monitoring.

The practical approach of the book makes it ideal for both aspiring CRAs and experienced professionals who want to refine their skills. At the end of the manual, you will find useful operational checklists designed as a real step-by-step approach to be used during monitoring visits, to check key information, follow-up and actions to be taken.

An indispensable companion to face every monitoring visit with method, safety and professionalism!