Drug Accountability and Compliance in Clinical Trials

Description

Course Overview

Drug accountability in clinical trials refer to the processes and procedures for managing investigational drugs (also known as study drugs or investigational medicinal products) in accordance with regulatory requirements and Good Clinical Practice (GCP) guidelines. The Drug Accountability and Compliance in Clinical Trials course is designed to provide participants with a comprehensive understanding of the principles and best practices of drug accountability and compliance within clinical trial settings. Participants will gain insights into the regulatory requirements, best practices, and challenges associated with managing investigational drugs throughout the clinical trial lifecycle. Key topics include drug supply management, dispensing procedures, documentation requirements, adverse event reporting, and regulatory compliance. Through interactive lectures, case studies, and practical exercises, participants will develop the knowledge and skills necessary to ensure accurate drug accountability and compliance in clinical trials.

Key Learning Objectives

• Understand the importance of drug accountability and compliance in clinical trials.
• Learn about the regulatory requirements governing investigational drug management, including Good Clinical Practice (GCP) guidelines and regulatory submissions.
• Gain insights into drug supply management practices, including storage, handling, labelling, and distribution procedures.
• Understand the documentation requirements for drug accountability, including drug dispensing records, reconciliation reports, and inventory logs.
• Learn about adverse event reporting requirements and the role of drug accountability in safety monitoring.
• Explore strategies for maintaining regulatory compliance and addressing challenges related to drug accountability in clinical trials.

Course Structure

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 30 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 suitable for clinical research professionals involved in drug accountability and compliance activities, including clinical research associates (CRAs), study coordinators (CRC), trial pharmacists, and others responsible for managing investigational drugs in clinical trials. No previous experience in clinical research is required. However, it’s important to note that this course exclusively focuses on providing an understanding of the drug accountability and compliance, and does not encompass all the knowledge needed to be a CRA or a CRC. For a more comprehensive program, please refer to our signature Industry-Bridging Programs.

Prerequisite

Having prior knowledge of ICH-GCP guidelines is beneficial as it enables you to apply this knowledge to ensure effective drug accountability and compliance. 

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: $823 inc. GST *

Industry Partner: $659 inc. GST *

Member: $700 inc. GST *

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