Description
Book SynopsisThis handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
Trade ReviewThe Oxford Handbook of Clinical and Healthcare Research packs a lot of information into a literally hand-sized ... book, with precise writing." * Norman M. Goldfarb, Journal of clinical research best practises *
A unique handbook that covers all the stages of clinical research along with a clear description of the regulations / processes that current researchers need to comply with. This truly addresses a much needed gap in the various research handbooks. * Dr Puja Myles, Associate Professor Health Protection and Epidemiology; Nottingham University *
Table of Contents1. Research - How and Why ; 2. Navigating Research Methods: Basic concepts in biostatistics and epidemiology ; 3. Navigating Research Methods: Quantitative and clinical / epidemiological methods ; 4. Navigating Research Methods: Qualitative methods ; 5. Navigating Research Methods: Evidence Based Medicine (EBM) ; 6. Navigating Research Methods: Critical ap-praisal ; 7. Navigating Research Methods: Clinical Audit ; 8. Setting the scene and ICH-GCP in clinical and healthcare research ; 9. Informed consent in a research setting ; 10. Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act ; 11. Role and Responsibilities: Investigators and Research Team ; 12. Role and Responsibilities: Sponsor ; 13. Monitoring ; 14. Clinical Trial Design ; 15. Clinical Trial Protocols: Study Protocol ; 16. Data Capture Tools: Case Report Form (CRF) ; 17. Clinical Trial Supplies: IMPs ; 18. IMP Accountability ; 19. Safety Reporting ; 20. Data management ; 21. Research Project Management ; 22. Essential Documents ; 23. Archiving ; 24. Audits and Inspections ; 25. Fraud and Misconduct ; 26. Authorship ; 27. Publication process ; 28. Start-up toolkit: from funding an idea, through implementation, to achieving an impact
