Clinical Trial Monitoring

Description

Course Overview

Clinical trial monitoring is a critical component of ensuring data integrity, quality, and compliance of clinical trial conduct to the study protocol, regulatory requirements, and ethical standards. This encompasses safeguarding the safety and welfare of trial participants, validating the accuracy and entirety of collected data, and verifying compliance with Good Clinical Practice (GCP) standards. Conducted by clinical research associates (CRAs), monitoring activities are aimed at upholding the credibility and soundness of the trial outcomes.

The Clinical Trial Monitoring course provides participants with a comprehensive understanding of the principles and practices of clinical trial monitoring coupled with practical skills for effective trial monitoring. Participants will learn about the role of the study monitor (or clinical research associate or CRA), key responsibilities, monitoring techniques, and best practices for effective monitoring throughout the trial lifecycle. Through interactive lectures, case studies, and practical exercises, participants will develop the knowledge and skills necessary to conduct monitoring activities and ensure the safety and well-being of trial participants, data integrity, and regulatory compliance.

Key Learning Objectives

• Understand the role and responsibilities of the clinical research associate (CRA)/study monitor in ensuring the quality and integrity of clinical trial data.
• Learn about the principles and guidelines governing clinical trial monitoring, including Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Gain insights into the planning and preparation phase of monitoring activities, including risk assessment, monitoring plan development, and site selection.
• Explore monitoring techniques and strategies, including on-site monitoring visits, remote monitoring, and risk-based monitoring (RBM) approaches.
• Learn how to effectively conduct monitoring visits (both onsite and remote), including site initiation visits, routine monitoring visits, and close-out visits.
• Understand the importance of data management and documentation in clinical trial monitoring, including source data verification and documentation review.
• Learn how to identify, report, and address protocol deviations, non-compliance issues, and adverse events during monitoring visits.
• Explore best practices for communication and collaboration with investigational sites, sponsors, and regulatory authorities throughout the monitoring process.

Course Structure

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 80 hours.

The lectures, exams, and supplementary materials are structured to be finished at your own pace. The practical masterclasses are conducted in real-time and have set schedules. For the most up-to-date information regarding masterclass schedules for this course, please reach out to us directly at info@clueoclinical.com. You’ll have up to 6 months from the onboarding date to finish all aspects of the course.

Target Audience

This course is tailored for individuals aspiring to pursue a career as a Clinical Research Associate (CRA), or newly hired CRA1 and other professionals responsible for monitoring the conduct of clinical trials. Prior clinical research experience is not required. It’s important to note that while this course focuses on the Clinical Trial Monitoring aspect of the CRA role, it does not encompass all the knowledge needed to become a CRA. For a comprehensive understanding of the CRA role, please refer to our comprehensive signature CRA Industry-Bridging program.

Prerequisite

Having prior knowledge of ICH-GCP guidelines and the regulatory framework governing clinical trials is beneficial as it enables you to apply this knowledge effectively in clinical trial monitoring.

Certification

• To receive the completion certificate for the course, you must achieve a minimum score of ≥ 80% on all assessments.
• You have the opportunity to attempt the final course exam twice. If you do not pass after both attempts, you will be required to retake the entire course from the beginning.

Upon meeting these criteria, your certificate of successful completion will be awarded within 48 hours of course completion.

Course Fee

Full fee: $1556 inc. GST *

Industry Partner: $1245 inc. GST *

Member: $1323 inc. GST *

(*Prices are subject to the indexation rate set by the Australian Taxation Office to account for inflation)