Clinical Trial Monitoring for Clinical Research Associates (CRAs)

Description

Course Overview

Clinical trial monitoring is integral to ensuring that clinical trials are conducted in compliance with regulatory guidelines and protocols. As a CRA, having a strong grasp of monitoring tasks and patient safety is essential to the success of clinical trials. By mastering these skills, you’ll be able to safeguard data integrity, protect participants, and ensure that trials run smoothly, leading to more reliable results and faster drug development.

The Clinical Trial Monitoring for Clinical Research Associates (CRAs) course is designed to equip professionals with the essential skills and knowledge to effectively monitor clinical trials, ensuring compliance, patient safety, and high-quality trial outcomes. Clinical trial monitoring is a critical aspect of clinical research, ensuring that all trial activities are conducted according to Good Clinical Practice (GCP), regulatory requirements, and trial protocols.

As a CRA, mastering trial monitoring is vital to ensure that sites are operating as per regulatory standards, trial data is accurate, and patient safety is prioritised. This course will provide you with a comprehensive understanding of monitoring responsibilities, including conducting site visits, reviewing case report forms (CRFs), ensuring data integrity, and addressing any discrepancies or compliance issues. By honing these skills, you’ll be able to make a significant contribution to the success of clinical trials, leading to faster approvals and better patient outcomes.

Key Learning Objectives

Upon completion of this course, you will:

• 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

This flexible, self-paced course is designed for busy professionals and includes:

1. Interactive Modules: Pre-recorded modules covering key topics such as trial monitoring responsibilities, site visit preparations, and GCP compliance.
2. Recorded Simulations: Real-world case studies and simulations that provide hands-on experience with trial monitoring tasks, including CRF review, identifying protocol deviations, and documenting observations.
3. Knowledge Assessments: Quizzes to reinforce learning and measure progress.
4. Downloadable Resources: Templates, checklists, and guides for effective site monitoring.

• Mode: Online, Self-Paced
• Duration: Approximately 40 hours

Who Should Enrol?

This course is ideal for:

1. Clinical Research Associates (CRAs): Professionals looking to enhance their trial monitoring skills and ensure compliance in clinical trials.
2. Clinical Trial Coordinators: Individuals who assist with trial management and want to deepen their understanding of trial monitoring processes.
3. Healthcare Professionals: Doctors, nurses, and other healthcare workers aiming to transition into clinical research or improve their monitoring capabilities.
4. Clinical Research Professionals: Those involved in clinical trial operations who need to understand monitoring roles and responsibilities more comprehensively.
5. Pharmaceutical Industry Professionals: Individuals seeking to strengthen their expertise in clinical trial monitoring, regulatory compliance, and patient safety.

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

• A bachelor’s degree or equivalent qualification in a relevant field (e.g., Life Sciences, Nursing, or related disciplines).
• ICH-GCP Certification or equivalent basic training in clinical research is required.
• Familiarity with basic clinical trial processes and terminology is recommended.

Certification

• A minimum score of 80% on the final assessment is required to receive certification.
• Learners have two attempts to pass the assessment. If additional attempts are needed, a fee will apply.

Course Fee

• Cost: $825 AUD inc. GST (12-month access to materials and resources)
• Discounts: Available for group enrolments and members (10%-30% off).
• For enquiries, please contact info@clueoclinical.com.