ICH guideline E8 (R1) General considerations for clinical studies
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About this course
Reasons to attend
Our course on ICH guideline E8 (R1) General Considerations for Clinical Studies is designed to give you a comprehensive understanding of the principles that guide clinical research. The International Council for Harmonisation (ICH) E8 guideline provides a framework for the design, conduct, analysis, and reporting of clinical studies. By the end of the course, you will be equipped with the knowledge and skills necessary to ensure that your research is conducted ethically and with the highest standards of quality. Join us for this engaging and informative course and take your clinical research skills to the next level!What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course time
- 2-hour webinar
Course description
Our comprehensive course on ICH guideline E8 (R1) General Considerations for Clinical Studies is designed to give you a solid understanding of the updated principles that guide clinical research studies. The International Council for Harmonisation (ICH) E8 guideline provides a comprehensive framework for the design, conduct, analysis, and reporting of clinical studies, and this course covers all the essential elements of this guideline. During the course, you will explore the updated key concepts and principles of ICH (E8), you will learn about the internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities, provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct. You will get an overview of the types of clinical studies performed during the product lifecycle, and the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives. Our engaging and informative course is packed with real-world examples, interactive case studies, and group discussions, which will give you a practical understanding of how to apply the ICH (E8) guidelines in your own clinical research projects. By enrolling in this course, you will gain a competitive advantage in the clinical research industry, as you will have the knowledge and skills necessary to ensure that your research is conducted ethically and with the highest standards of quality. You will also gain a comprehensive understanding of the regulatory landscape of clinical studies, which will help you to comply with regulations and maintain compliance throughout the study lifecycle.Programme highlight
- Introduction to the ICH (E8) guideline and its key principles
- Ethics and the protection of human subjects in clinical research
- Designing quality into clinical studies
- Drug development planning
- Design elements and data sources for clinical studies
- Conduct, safety: monitoring and reporting
- Interactive case studies and real-world examples to apply ICH (E8) guideline in clinical research projects
- Best practices for designing, conducting, analysing, and reporting clinical studies.
Learning objectives
- Understand the fundamental principles that guide clinical research studies
- Gain an in-depth knowledge of the ICH (E8) guideline and its practical applications
- Develop a strong understanding of ethics, data quality, and risk management in clinical research
- Apply ICH (E8) guideline to real-world clinical research scenarios
- Gain best practices for designing, conducting, analysing, and reporting clinical studies
Who should attend
This course on ICH E8 (R1) General Considerations for Clinical Studies is designed for anyone involved in the planning, conduct, or oversight of clinical research studies.
This includes clinical research professionals such as clinical research coordinators, data managers, regulatory affairs specialists, and clinical project managers, as well as investigators, sponsors, ethics committee and institutional review board (IRB) members. Whether you are new to clinical research or have years of experience, this course will provide you with a comprehensive understanding of the updated fundamental principles that guide clinical studies and equip you with the knowledge and skills necessary to ensure that your research is conducted ethically and with the highest standards of quality.Competencies
This course covers competencies that are part of the ECCRT Competency Framework :
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
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