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Mastering Interim Monitoring Visits

Interim Monitoring Visit Excellence in Clinical Research (InterimCRExcellence)

  • Ended
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  • Online

Course Description

The Interim Monitoring Visit Excellence in Clinical Research program is designed to equip clinical research professionals with the knowledge and skills necessary to proficiently plan, conduct, and follow up on interim monitoring visits. Participants will gain an understanding of the critical role of interim monitoring in ensuring data quality, patient safety, and regulatory compliance. Below is an outline of the course: - Introduction to Interim Monitoring Visits. - Understanding the purpose and objectives of interim monitoring. - Regulatory guidelines and ethical considerations. - Role of interim monitoring in ensuring data integrity. - Navigating the challenges of remote monitoring. - Preparation for Interim Monitoring Visits. - Developing an interim monitoring visit plan and checklist. - Reviewing study protocols and key documentation. - Identifying risk factors and critical data points. - Conducting Effective Interim Monitoring Visits. - Communication and coordination with site personnel. - Conducting remote data verification and source document review. - Identifying discrepancies and potential issues. - Ensuring data quality and patient safety. - Documentation and Reporting. - Documentation of interim monitoring visit findings and observations. - Preparing monitoring visit reports and documentation. - Regulatory submissions and documentation requirements. - Ensuring accuracy and consistency in reporting. - Interactive Workshop: Simulated Interim Monitoring Visits. Analyzing realistic interim monitoring visit scenarios. Group discussions on challenges and best practices. - Hands-on exercises: conducting mock interim monitoring visits. Role-playing activities: simulating site interactions and data review. - Follow-Up and Data Integrity. - Reviewing interim monitoring visit findings with the study team. - Addressing queries and discrepancies with site personnel. - Ensuring timely resolution of identified issues. - Practical application of interim monitoring visit planning and conduct.

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