Oxford Handbook of Clinical and Healthcare Research

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. John`s College), West Suffolk Hospital, UK, Susan Fisher, Research Manager, Medical Research Council (Human Nutrition Research), Cambridge, UK

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