Oxford Handbook of Clinical and Healthcare Research (Oxford Medical Handbooks)

This 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.

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