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Oxford Handbook of Clinical and Healthcare Research


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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


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 *

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