A Comprehensive Guide for Novice Researcher in Clinical Trials

Miltiadis D. Lytras is an expert in advanced computer science and management, editor, lecturer, and research consultant, with extensive experience in academia and the business sector in Europe and Asia. Dr. Lytras is a Research Professor at Deree College - The American College of Greece and a Distinguished Scientist at the King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia. Dr. Lytras is a world-class expert in the fields of cognitive computing, information systems, technology enabled innovation, social networks, computers in human behavior, and knowledge management. In his work, Dr. Lytras seeks to bring together and exploit synergies among scholars and experts committed to enhancing the quality of education for all. Basim Alsaywid, Pediatric Urology Surgeon, graduated from King Abdulaziz University then completed Saudi Board of Urology in 2007. He obtained his Pediatric Urology Training Certificate from a fellowship at Westmead Children Hospital and then Sydney Children Hospital at Randwick, Sydney, Australia. During his fellowship training, he completed his Master of Medicine degree from the University of Sydney in Clinical Epide?miology with focus on biostatistics, and then he completed his Master’s in Health Profession Education from King Saud Bin Abdulaziz University for Health Sciences, Saudi Arabia. Dr. Alsaywid founded the research offices at the College of Medicine and College of Applied Health Sciences at King Saud Bin Abdulaziz University for Health Sciences in Jeddah. Also, he founded and chaired the Research and Development Department at Saudi Commission for Health Specialties in Riyadh. Currently, Dr. Alsaywid is the Director of Education and Research Skills at Saudi National Institute of Health, Riyadh, Saudi Arabia. Dr. Doaa Alsaleh, MD, PhD, MSCR, is a physician-scientist with over a decade of experience specializing in clinical trials and real-world evidence (RWE) outcomes research. She completed a clinical research fellowship at Weill Cornell Medicine, followed by a Master’s and PhD in Clinical Research from the Icahn School of Medicine at Mount Sinai.Dr. Alsaleh has led and designed national training programs in clinical trials and public health research in collaboration with the Saudi National Institute of Health and the Public Health Authority. Her expertise includes methodology, data analytics, and predictive modeling.She has published in peer-reviewed journals and presented internationally, including at the American Association for Thoracic Surgery (AATS) on CABG outcomes in diabetes. She received a research grant from Weill Cornell to lead a pilot clinical trial.Dr. Alsaleh currently serves as Section Head of the Scientific Review Unit and Associate Research Scientist at KAIMRC, supporting Saudi Arabia’s Vision 2030 through leadership in clinical research.

• 1. Introduction to Health Research Methods2. History of Clinical Trials3. Clinical Trial Designs4. Clinical Trial Essentials5. Ethics and Good Clinical Practice in Clinical Trials6. Trial Protocol Development7. Clinical Research Site Operation8. Clinical Data Management9. Clinical Trial Monitoring10. Principles of Statistics in Clinical Trials11. Reporting Clinical Trials12. Essentials of Project Management13. Regulatory Affairs of Clinical Trial in Saudi Arabia14. Training Programs and Job Opportunity in Clinical Trial Industry