Table of Contents

1: Research - How and Why
2: Basic concepts in biostatistics and epidemiology
3: Quantitative and clinical / epidemiological methods
4: Qualitative methods
5: Evidence Based Medicine (EBM)
6: Critical appraisal
7: 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. John`s College), West Suffolk Hospital, UK, Susan Fisher, Research Manager, Medical Research Council (Human Nutrition Research), Cambridge, UK

Reviews

The 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*