Oxford Handbook of Clinical and Healthcare Research

The Oxford Handbook of Clinical and Healthcare Research is a practical, concise, and easy-to-use reference for the full range of clinical and healthcare research topics, while incorporating evidence based medicine. Comprehensively providing a wide breadth of knowledge, this handbook clearly covers both the qualitative and quantitative aspects.

This handbook includes clear instructions on the legislative requirements as well as the practical requirements of commissioning, conducting, analysing, and reporting research for those in clinical or healthcare practice, education or training. This book has been written with Good Clinical Practice (GCP) education in mind, giving valuable information needed for the accredited certificates and diploma-level benchmark exams now commonly required by employers.

Whether you need practical advice on setting up and running a trial, negotiating regulations, learning vital research skills, or to study the underpinning concepts of research methods, this handbook will give you the vital information, clinical evidence, and guidance you need.

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

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