Regulatory Framework and Ethics in Clinical Research

Description

Course Overview

In clinical research, understanding and adhering to regulatory frameworks and ethical standards is essential for ensuring the safety of participants, maintaining data integrity, and achieving successful trial outcomes. This course is designed to provide clinical research professionals with the knowledge required to navigate complex regulations and uphold the highest ethical standards in clinical trials.

Mastering the regulatory and ethical aspects of clinical trials is crucial for ensuring the safety of participants, maintaining trial integrity, and ensuring compliance with legal requirements. A deep understanding of these principles will not only help prevent costly regulatory violations but will also help manage trial risks, improve patient outcomes, and contribute to the overall success of clinical trials. For clinical research professionals, this knowledge is fundamental to driving efficient and ethical clinical trial practices.

The Regulatory Framework and Ethics in Clinical Trials for Clinical Research Professionals course is designed to equip professionals with a deep understanding of the key regulatory bodies, ethical principles, and compliance requirements that govern clinical trials. Mastering these principles will not only ensure that you remain audit-ready but also contribute to the overall success and credibility of your clinical trials.

Key Learning Objectives

Upon completion of this course, you will:

• Gain an in-depth understanding of the regulatory framework governing clinical trials, including GCP, TGA, FDA, EMA, ICH, and local regulations.
• Learn the core ethical principles that guide clinical research, including informed consent, patient rights, confidentiality, and safety.
• Understand the role of regulatory authorities and ethics committees in clinical trial oversight.
• Learn how to ensure compliance with both national and international regulations.
• Identify and manage key ethical dilemmas in clinical trials, and understand their implications for trial outcomes.
• Gain practical knowledge on document management, audit processes, and reporting standards.

Course Structure

This course is designed for busy professionals and is delivered through online, self-paced learning with recorded simulations that provide real-life scenarios for effective learning. The course includes:

• Interactive modules that cover essential regulatory frameworks and ethical standards in clinical trials.
• Recorded simulations and real-world case studies to apply your learning to practical scenarios.
• Quizzes and assignments to help reinforce your understanding and ensure retention of critical information.
• Final assessment to evaluate your knowledge and award certification upon successful completion.
• Downloadable Resources: Templates, checklists, and guides.
• Mode: 100% Online, Self-Paced
• Duration: Approximately 15 hours

Who Should Enrol?

This course is ideal for:

• Clinical Research Associates (CRAs)
• Clinical Research Coordinators (CRCs)
• Clinical Project Managers (CPMs)
• Clinical Trial Managers (CTMs)
• Regulatory Affairs Professionals
• Anyone involved in the design, management, or oversight of clinical trials

Prerequisite

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

Certification Requirements

• A minimum score of 80% on the final assessment is required to receive the accredited certification. This certification is a mark of your proficiency in clinical trial regulatory and ethical compliance, recognised by industry leaders.
• Learners have two attempts to pass the assessment. If additional attempts are needed, a fee will apply.

Course Fee

• Cost: $525 AUD inc. GST (12-month access to materials and resources)
• Discounts: Available for group enrolments and members (10%-30% off).
• For all inquiries, please contact info@clueoclinical.com