Masterclass: Performing Source Document Verification (SDV) and Risk-Based Monitoring

Are you an aspiring or early-career clinical research professional wanting to enhance your industry skills to enhance your CV and job-readiness? Are you an aspiring or early-career clinical research professional aiming to enhance your CV and job readiness? Mastering Source Document Verification (SDV) and conducting effective On-Site Monitoring are critical skills for a successful Clinical Research Associate (CRA).

Our 2-hour interactive masterclass is designed to equip you with the industry’s best practices, expert knowledge and practical skills needed to excel as a CRA, ensuring data integrity and regulatory compliance in clinical trials.

Key Benefits of Attending:

🔹 Enhanced Monitoring Competence: Develop the skills necessary to perform thorough SDV and effective on-site monitoring, ensuring high-quality clinical trial data.

🔹 Improved Regulatory Compliance: Learn to navigate complex regulatory requirements, reducing the risk of non-compliance during clinical trials.

🔹 Career Advancement: Strengthen your CV with specialised training, increasing your competitiveness in the clinical research job market.

🔹 Practical Application: Engage in interactive sessions that provide hands-on experience with real-world scenarios, preparing you for challenges encountered in the field.

🔹 Enhanced Monitoring Efficiency: Develop the ability to conduct effective remote monitoring, reducing the need for frequent on-site visits while maintaining data quality.

🔹 Improved Risk Management: Implement RBM strategies to proactively identify and mitigate potential issues in clinical trials.

🔹 Regulatory Adherence: Ensure compliance with current regulatory standards for monitoring, minimizing the risk of non-compliance.

🔹 Professional Development: Expand your skill set with contemporary monitoring techniques, increasing your value in the clinical research field.

What You’ll Learn:

✅ Fundamentals of Source Document Verification (SDV): Understand the process of comparing case report form data against original source documents to ensure accuracy and completeness.

✅ Effective On-Site Monitoring Techniques: Learn how to conduct various types of site visits, including qualification, initiation, routine, and close-out visits, to ensure compliance with study protocols and regulatory requirements.

✅ Regulatory Compliance and Good Clinical Practice (GCP): Gain insights into adhering to GCP guidelines and maintaining ethical standards during clinical trial monitoring.

✅ Data Integrity and Quality Assurance: Develop skills to ensure the accuracy, consistency, and reliability of clinical trial data through meticulous monitoring practices.

✅ Foundations of Remote Monitoring: Understand the principles and benefits of remote monitoring, including strategies for data review, query management, and identifying site compliance issues without physical visits.

✅ Risk-Based Monitoring (RBM) Strategies: Explore the core concepts of RBM, focusing on prioritizing monitoring activities based on risk assessment to enhance efficiency and resource allocation.

✅ Regulatory Guidelines and Compliance: Gain insights into the regulatory frameworks governing remote and risk-based monitoring, ensuring adherence to Good Clinical Practice (GCP) and other relevant guidelines.

✅ Data Management and Centralised Monitoring: Learn how to utilize centralized data aggregation and statistical monitoring techniques to oversee trial progress and maintain data quality.

✅ Practical Application and Case Studies: Engage with real-world scenarios to apply remote and RBM methodologies, enhancing problem-solving skills and decision-making in clinical trial monitoring.

Who Should Attend?

This masterclass is ideal for:

🔹 Aspiring Clinical Research Associates: Individuals seeking to enter the field of clinical research and develop foundational monitoring skills.

🔹 Early-Career CRAs: Professionals aiming to enhance their proficiency in SDV and on-site monitoring to advance their careers.

🔹 Clinical Trial Coordinators and Managers: Personnel involved in overseeing clinical trial operations who wish to deepen their understanding of monitoring processes.

🔹 Quality Assurance Specialists: Individuals responsible for ensuring compliance and data integrity in clinical research settings.

By participating in this masterclass, you’ll gain practical insights and tools to excel in Source Document Verification (SDV) and On-Site Monitoring as a Clinical Research Associate (CRA), ensuring the highest standards of data integrity and regulatory compliance in your clinical trials.

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!