Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. Foreword - p. xi 7. Preface - p. xiii 8. Acknowledgments - p. xv 9. Chapter 1. Historical development of clinical research - p. 1 10. Chapter 2. Clinical research - p. 13 11. Chapter 3. Clinical trial approval in world - p. 19 12. Chapter 4. Project management in clinical trials - p. 57 13. Chapter 5. Role of stakeholders - p. 77 14. Chapter 6. Clinical trial budget assessment and preparation - p. 87 15. Chapter 7. Steps to conduct clinical trials - p. 95 16. Chapter 8. Clinical data management - p. 125 17. Chapter 9. Audits and inspection - p. 135 18. Chapter 10. Serious adverse event reporting and compensation - p. 141 19. Chapter 11. Randomization, bias, and blinding - p. 157 20. Chapter 12. Basic statistical tools for clinical data analysis - p. 177 21. Chapter 13. Advanced statistical tools for clinical data analysis - p. 197 22. Chapter 14. Pharmacovigilance - p. 215 23. Chapter 15. Clinical study report - p. 239 24. Chapter 16. Bioavailability and bioequivalence study - p. 255 25. Chapter 17. Risk-based monitoring - p. 269 26. Chapter 18. Decentralized clinical trials - p. 281 27. Chapter 19. Electronic clinical outcome assessment and electronic patient-reported outcome - p. 297 28. Update of ICH-GCP (addendum R2 and R3) - p. 307 29. Chapter 21. Frequently asked questions - p. 317 30. Index - p. 323
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iv 6. Foreword - p. xi 7. Preface - p. xiii 8. Acknowledgments - p. xv 9. Chapter 1. Historical development of clinical research - p. 1 10. Chapter 2. Clinical research - p. 13 11. Chapter 3. Clinical trial approval in world - p. 19 12. Chapter 4. Project management in clinical trials - p. 57 13. Chapter 5. Role of stakeholders - p. 77 14. Chapter 6. Clinical trial budget assessment and preparation - p. 87 15. Chapter 7. Steps to conduct clinical trials - p. 95 16. Chapter 8. Clinical data management - p. 125 17. Chapter 9. Audits and inspection - p. 135 18. Chapter 10. Serious adverse event reporting and compensation - p. 141 19. Chapter 11. Randomization, bias, and blinding - p. 157 20. Chapter 12. Basic statistical tools for clinical data analysis - p. 177 21. Chapter 13. Advanced statistical tools for clinical data analysis - p. 197 22. Chapter 14. Pharmacovigilance - p. 215 23. Chapter 15. Clinical study report - p. 239 24. Chapter 16. Bioavailability and bioequivalence study - p. 255 25. Chapter 17. Risk-based monitoring - p. 269 26. Chapter 18. Decentralized clinical trials - p. 281 27. Chapter 19. Electronic clinical outcome assessment and electronic patient-reported outcome - p. 297 28. Update of ICH-GCP (addendum R2 and R3) - p. 307 29. Chapter 21. Frequently asked questions - p. 317 30. Index - p. 323
