9788197181832 (1 Ergebnisse)

Soft cover. Zustand: New. Contents: 1. Clinical Research A Clinical Investigator's Perspective 2. Medical Device Development, Process and Regulation 3. Preclinical Drug Development 4. Phases of Clinical Trials 5. Phase 0 Micro dosing Studies 6. Clinical Research Planning 7. Clinical Research Design 8. Clinical Research Protocol 9. Designing Case Report Forms 10. Process of Randomization in Clinical Trials 11. Investigational Medicinal Products 12. Multi center Clinical Trials 13. Good Clinical Research Practice 14. Role and Responsibilities of Sponsor 15. Role and Responsibilities of Principal Investigator 16. Ethical Consideration in Clinical Research Special Reference to Developing Countries 17. Informed Consent in Clinical Research 18. Monitoring in Clinical Trials 19. Quality Assurance in Clinical Research 20. Pharmacovigilance and Drug Safety 21. Data and Safety Monitoring Board and Monitoring Plan 22. Standard Operating Procedures 23. Archiving Clinical Research Documents 24. Evidence Based Medicine 25. Clinical Research Data Management 26. Clinical Biostatistics, (a) Biostatistics for clinical Researcher, (b) Terminology used in Biostatistics In "A Practical Guide to Human Research and Clinical Trials," delve into the intricate world of clinical research as health professionals navigate the complexities of conducting trials and recruiting subjects. This comprehensive textbook offers a detailed exploration of the scientific, administrative, and regulatory aspects crucial to the successful execution of clinical trials. Designed as a valuable resource for both seasoned professionals and aspiring students, this book illuminates key concepts with insightful diagrams and practical checklists, making it an essential teaching aid and a go-to reference guide. From the design and implementation to the analysis of clinical trials, this book equips readers with the knowledge and tools necessary to navigate every phase of the research process. "A Practical Guide to Human Research and Clinical Trials" is a must-read for those seeking to excel in the field of health and research, offering a wealth of knowledge to empower and inspire.