Course Overview
Good Clinical Practice (GCP) is the cornerstone of clinical trial compliance, ensuring that clinical trials are conducted with integrity, safety, and transparency. Mastering GCP ensures that clinical research professionals can effectively manage compliance, reduce risks during audits, and maintain high ethical standards. This training is designed to help you successfully navigate audits, meet regulatory expectations, and contribute to the successful completion of clinical trials.
This comprehensive and fully accredited Good Clinical Practice (GCP) E6 R2 Training course is designed for clinical research professionals looking to master the latest industry standards and ensure successful trial outcomes. Adhering to the rigorous guidelines of the TransCelerate GCP Training Mutual Recognition Program, this course provides comprehensive knowledge of GCP principles, audit readiness, and compliance best practices crucial for clinical trials.
In today’s clinical research industry, ensuring compliance with GCP E6 R2 guidelines is critical for maintaining the integrity of trial data, protecting participant safety, and meeting regulatory requirements. Through this self-paced online course, you will gain the skills needed to navigate audits, manage compliance challenges, and guarantee that clinical trials meet the highest standards of quality and ethics.
Key Learning Objectives
- Understand the principles and objectives of Good Clinical Practice (GCP) guidelines as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Master the key principles and requirements of GCP E6 R2 guidelines.
- Understand the regulatory framework governing clinical trials and the roles and responsibilities of key stakeholders, including investigators, sponsors, and regulatory authorities.
- Understand the GCP E6 R2 guidelines and their application in clinical trials.
- Learn how to conduct clinical trials in compliance with ethical principles and regulatory requirements, ensuring the safety, rights, and well-being of trial participants.
- Gain knowledge of the informed consent process, including the requirements for obtaining and documenting informed consent from trial participants.
- Learn about the principles of data management, including data collection, handling, and storage, as well as the importance of data integrity and quality assurance.
- Understand the importance of protocol adherence and the procedures for handling protocol deviations, adverse events, and serious adverse events during clinical trials.
- Learn to manage clinical trial compliance through all trial phases.
- Gain confidence in managing documentation and trial data in compliance with regulatory standards.
- Learn best practices for maintaining patient safety and ensuring trial integrity.
- Gain practical insights and best practices for ensuring compliance with GCP guidelines and regulatory requirements throughout the lifecycle of a clinical trial, from study initiation to closeout.
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: Covering key topics for understanding GCP E6 R2 guidelines.
- Recorded simulations: Real-world case scenarios that provide practical applications of course material.
- Assessments: Quizzes and knowledge checks at the end of each module to reinforce learning.
- Final assessment for certification eligibility.
- Downloadable Resources: Templates, guides, and checklists for reference.
- Mode: 100% Online, Self-Paced
- Duration: Approximately 20 hours
Who Should Enrol?
This course is ideal for:
- Clinical Research Associates (CRAs)
- Clinical Research Coordinators (CRCs)
- Clinical Trial Managers (CTMs)
- Clinical Project Managers (CPMs)
- Anyone involved in clinical trials or pharmaceutical research
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 will demonstrate your mastery of GCP E6 R2 guidelines.
- Learners have two attempts to pass the assessment. If additional attempts are needed, a fee will apply.
Course Fee
- Cost: $495 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@citium.academy