Course Description
This course provides a comprehensive exploration of the operational, ethical, and regulatory aspects of clinical trial monitoring and patient recruitment. Participants will gain practical knowledge of monitoring strategies that safeguard data integrity, patient safety, and compliance with Good Clinical Practice (GCP) and international regulations.
Through a combination of lectures, case studies, and applied exercises, students will learn how to design and implement effective monitoring plans, assess trial quality, and troubleshoot challenges in site management. The course also emphasizes evidence-based approaches to patient recruitment and retention, exploring barriers to enrollment, strategies for engaging diverse populations, and tools for meeting recruitment timelines.
By the end of the course, participants will be able to integrate scientific, operational, and ethical considerations into monitoring and recruitment strategies to optimize trial outcomes.
Course Summary
Upcoming Courses
Learning Objectives
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Understand the purpose and scope of trial monitoring
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Apply risk-based monitoring (RBM) and centralized monitoring techniques to increase efficiency.
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Develop strategies for patient recruitment and retention
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Communicate effectively with investigators and sites
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Evaluate the effectiveness of monitoring and recruitment strategies using key performance indicators (KPIs).
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Identify and implement best practices for site initiation, monitoring visits, and closeout procedures.
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Analyze common barriers to patient recruitment and retention and apply evidence-based strategies to address them.
Who Should Attend
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CRAs and CRCs
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Trial Managers and Site Coordinators
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Principal Investigators
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Study Managers
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Research Nurses
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Clinical Operations staff
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Anyone pursuing monitoring or recruitment-focused roles
Course Outline
Module 1
The Role of Monitoring in Clinical Trials
Module 2
Monitoring Visits: Pre-study, Site Initiation, Interim, and Closeout
Module 3
Common Monitoring Findings and Corrective Actions
Module 4
Patient Recruitment Strategies
Module 5
Overcoming Recruitment and Retention Challenges
Module 6
Best Practices in Site Communication
Interactive Activities
- •Mock monitoring visit with sample checklists
- •Workshop: Designing a patient recruitment campaign
- •Group discussion: Solving real-world recruitment barriers
