Full Description
A Comprehensive Guide for Novice Researcher in Clinical Trials is a must-have resource for individuals embarking on the journey of clinical research. This book is tailored for beginners, offering a clear and structured introduction to the vital principles, methodologies, and skills required to design and conduct robust clinical trials. Spanning 13 chapters, it meticulously covers the entire clinical trial process, emphasizing Good Clinical Practice (GCP) standards. From foundational research concepts to advanced trial strategies, the guide empowers readers to confidently navigate the complexities of clinical trials and contribute meaningfully to the field of healthcare.
In addition to its foundational content, the book addresses a variety of important topics, such as ethical considerations, regulatory compliance, and the development of trial protocols. It explores different trial designs, types of bias, and the historical evolution of clinical research. Practical sections on data management, monitoring, statistical analysis, and project management offer readers hands-on guidance for real-world application. Notably, the book includes a dedicated focus on regulatory affairs in Saudi Arabia, making it particularly valuable for health professionals in that region.
Contents
1. Introduction to Health Research Methods
2. History of Clinical Trials
3. Clinical Trial Designs
4. Clinical Trial Essentials
5. Ethics and Good Clinical Practice in Clinical Trials
6. Trial Protocol Development
7. Clinical Research Site Operation
8. Clinical Data Management
9. Clinical Trial Monitoring
10. Principles of Statistics in Clinical Trials
11. Reporting Clinical Trials
12. Essentials of Project Management
13. Regulatory Affairs of Clinical Trial in Saudi Arabia
14. Training Programs and Job Opportunity in Clinical Trial Industry
