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Oxford Handbook of Clinical and Healthcare Research


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Table of Contents

1. 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

About the Author

Sumantra Ray, Senior Medical Advisor/Clinician Scientist; Chair, Medical Research Council (Human Nutrition Research); UK Need for Nutrition Education/Innovation Programme (NNEdPro), Cambridge University Hospitals/School of Clinical Medicine, Sue Fitzpatrick, Director; Former Head of Education and Training, Redtree People and Sue Fitzpatrick Training; Institute of Clinical Research, Rajna Golubic, Gates Scholar; Trust Doctor, Medical Research Council and University of Cambridge (Epidemiology Unit and St. Johns College), West Suffolk Hospital, UK, Susan Fisher, Research Manager, Medical Research Council (Human Nutrition Research), Cambridge, UK


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 *

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