Practical Guide to Improving SIVs and Site Training

This guide provides a comprehensive approach to enhancing site initiation visits (SIVs) and site training in clinical trials. It identifies the need for improved training for investigators and clinical research personnel on study roles, compliance, and standard operating procedures (SOPs). The document outlines the significant costs associated with inadequate training and the potential financial implications of receiving FDA Form 483. It discusses the importance of implementing a purpose-built learning management system (LMS) to streamline training processes, reduce SIV training time, and improve overall efficiency. The guide also emphasizes the effectiveness of microlearning techniques, which focus on short, targeted content to enhance knowledge retention. By adopting these methods, sponsors and contract research organizations (CROs) can better engage site staff throughout the study, ultimately leading to improved compliance and reduced protocol deviations. The document concludes by suggesting practical applications of microlearning to enhance study training effectiveness.