Writing Monitoring Visit Reports (MVRs), Documenting Findings, and Escalating Non-Compliance

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Description

Are you an aspiring or early-career clinical research professional wanting to enhance your industry skills to enhance your CV and job readiness? In clinical research, a Clinical Research Associate (CRA) is required to effectively write Monitoring Visit Reports (MVRs), document findings, and escalate non-compliance following every visit. This is for maintaining site compliance, data integrity and ensuring patient safety.

Our 2-hour interactive masterclass is designed to provide you with comprehensive knowledge and practical skills to effectively conduct close-out visits, ensuring compliance with regulatory standards and the integrity of study data. You’ll also have the opportunity to draft your own MVR and receive personalised feedback by an industry expert.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBPTM), 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.

Key Benefits

• Enhanced Documentation Skills: Improve your ability to create detailed and accurate MVRs, contributing to the overall quality and compliance of clinical trials.
• Effective Issue Management: Learn how to identify, document, and escalate non-compliance issues promptly, ensuring timely resolution and adherence to regulatory standards.
• Regulatory Adherence: Ensure your monitoring practices align with GCP guidelines and other regulatory requirements, minimizing the risk of non-compliance.
• Professional Development: Strengthen your expertise in critical aspects of clinical trial monitoring, enhancing your career prospects and value in the clinical research field.

By participating in this masterclass, you’ll gain hands-on experience, practical insights and tools to excel in writing Monitoring Visit Reports (MVRs), documenting findings, and effectively escalating non-compliance, thereby ensuring the highest standards of data integrity and regulatory compliance in your clinical trials.

What You’ll Learn:

• Crafting Effective Monitoring Visit Reports: Master the art of writing clear, concise, and comprehensive MVRs that accurately reflect site activities, observations, and compliance status. Learn the key components to include, such as visit dates, personnel involved, reviewed documents, identified issues, and corrective actions.
• Documenting Findings with Precision: Develop skills to meticulously document observations, deviations, and non-compliance issues, ensuring that all details are recorded accurately and in a timely manner. Understand the importance of thorough documentation in supporting regulatory compliance and audit readiness.
• Escalating Non-Compliance Effectively: Learn the protocols for identifying, reporting, and escalating non-compliance issues to appropriate stakeholders. Understand the escalation process, including documentation, remediation, and reporting, to ensure timely resolution and adherence to regulatory standards.
• Ensuring Regulatory Compliance: Gain insights into the regulatory frameworks governing clinical trials, including Good Clinical Practice (GCP) guidelines, and learn how to align your monitoring activities with these standards to uphold the integrity of the study.

Who Should Attend?

• Aspiring and Early-career Clinical Research Associates (CRAs): Professionals seeking to enhance their skills in monitoring, documentation, and compliance management.
• Clinical Trial Managers and Coordinators: Individuals responsible for overseeing trial operations and ensuring adherence to protocols and regulations.
• Quality Assurance Specialists: Personnel involved in maintaining the quality and compliance of clinical trials.
• Regulatory Affairs Professionals: Those focusing on ensuring that clinical trials meet all regulatory requirements and standards.

Format, Date and Time

This is a paid online event. Current Clueo Clinical IBP^TM trainees: please follow the instructions provided during your onboarding.

Attendees will receive access link and password before the event.