Oxford Handbook of Clinical and Healthcare Research

Edited by Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and edited with assistance of Sarah Gibbings

Oxford Medical Handbooks

Reflects the latest legislative framework
Provides equal focus to qualitative and quantitative aspects
Covers the breadth of information required for GCP education and related examination, including FPH
Comprehensive start-up toolkit for new researchers in any health-related field
App available from the App Store, Google Play, and MedHand Bookstore.

Oxford Handbook of Clinical and Healthcare Research

Edited by Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and edited with assistance of Sarah Gibbings

Description

The Oxford Handbook of Clinical and Healthcare Research is an evidence-based, succinct, and easy-to-use reference for the full range of clinical and healthcare research topics. Providing a wide breadth of essential knowledge, this comprehensive text takes the researcher through the steps from general good clinical practice in healthcare research to the process and management of research.

This handbook includes clear instructions on the legislative and practical requirements of commissioning, conducting, analysing, and reporting research for those in clinical or healthcare practice, education, or training. Written with Good Clinical Practice (GCP) education in mind, it includes valuable information needed for the accredited certificates and diploma-level benchmark exams now commonly required by employers. This is a definitive text for all clinical and healthcare research students, as well as graduates with an interest in clinical and healthcare research.

Oxford Handbook of Clinical and Healthcare Research

Edited by Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and edited with assistance of Sarah Gibbings

Oxford Medical Handbooks

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

Oxford Handbook of Clinical and Healthcare Research

Edited by Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and edited with assistance of Sarah Gibbings

Oxford Medical Handbooks

Author Information

Edited by Sumantra Ray, Senior Medical Advisor/Clinician Scientist, Medical Research Council (Human Nutrition Research); Chair of UK Need for Nutrition Education/Innovation Programme (NNEdPro), Cambridge University Hospitals/School of Clinical Medicine, Sue Fitzpatrick, Director; Former Head of Education and Training, Institute of Clinical Research, Director of Redtree People and Sue Fitzpatrick training, Rajna Golubic, Doctor, West Suffolk Hospital; Gates Scholar, St. John's College, MRC Epidemiology Unit; Deputising Global Innovation Panel Member and Research Quality Lead, UK Need for Nutrition Education/Innovation Programme (NNEdPro), Susan Fisher, Research Manager, Medical Research Council (Human Nutrition Research), Cambridge, UK, and edited with assistance of Sarah Gibbings, Research Assistant / Co-ordinator, Medical Research Council (Human Nutrition Research), Cambridge

Contributors:

Pauline Allen
eCRF/CRF Design Manager, Syna Qua non Ltd, Diss Business Park, UK

Suzanna Almoosawi
Research Associate, Newcastle University, Human Nutrition, Research Centre and Institute of Health & Society, Medical School, Newcastle University, UK

Sarah Casey
Health, Safety and Quality Manager, Medical Research Council, Human Nutrition Research, Elsie Widdowson Laboratory, Cambridge, UK

Darren Cole
Manager of Data Operations, Medical Research Council, Human Nutrition Research, Elsie Widdowson Laboratory, Cambridge, UK

Nicky Dodsworth
VP, Global Quality Assurance, Premier Research, Wokingham, UK

Nina Downes
Director, Diamond Clinical, High Wycombe, UK

Joan Gandy
Lead Scientific Advisor, UK Need for Nutrition Education/Innovation Programme (NNEdPro), Cambridge, UK

Helen Glenny
Clinical Research Consultant, Welwyn, UK

Chris Graf
Associate Editorial Director, Wiley-Blackwell UK

Karen Grover
eCRF/CRF Design Manager, Syna Qua non Ltd, Diss, UK

Lyn Haynes
Senior Lecturer, Canterbury Christchurch University, Canterbury, UK

Janice Hedgecock
Director, Greatspur Clinical Development, Norwich, UK

Babara Hepworth Jones
Head, Process and Training, Country Clinical Operations UK, Roache Product Ltd, Welwyn Garden City, UK

Helen Hill
Research Fellow, University of Liverpool, Department of Women`s and Children's Health, Institute of Translational Medicine, Liverpool, UK

Liz Hooper
Archivist and Records Management Consultant, Phlex Global, Ammersham, UK

Sheri Hubby
Director, US Quality Assurance, USA Premier Research Group Limited, Austin, Texas, USA

Golam Kabir
Researcher, University of Dundee Medical School, Dundeee, UK

Priya Kalia
Research Associate, Biomaterials, Biomimetics, Biophotonics Division, Dental Institute, King's College London, UK

Eric Klaver
Director, FourPlus Clinical, Amsterdam, The Netherlands

Chim Lang
Professor of Cardiology, Division of Cardiovascular and Diabetes Medicine, Ninewells Hospital and Medical School, Dundee,UK

Celia Laur
Researcher in Applied Health Sciences, University of Waterloo, Onatario, Canada

Sue Miles
Head of Clinical Trials, Brecon Pharmaceuticals Ltd, Hay-on-Wye, UK

Polly Page
Group leader: Nutrition, Surveys and Studies Medical Research Council, Human Nutrition Research, Elsie Widdowson Laboratory, Cambridge, UK

Richard Parker
Statistician, University of Edinburgh, Edinburgh, UK

Minha Rajput Ray
Lead Medical Advisor, UK Need for Nutrition Education/Innovation Programme (NNEdPro), Cambridge, UK

Alan Robertson
Specialty registrar/Clinical Research Fellow, Division of Cardiovascular and Diabetes Medicine, Ninewells Hospital and Medical School, Dundee, UK

David Talbot
Director, Diamond Clinical, High Wycombe, UK

Ben Thompson
Postgraduate, British College of Osteopathic Medicine, London, UK

Ruzan Udumyan
Epidemiologist at Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Sweden

Cheryl Whitehead
Independent Pharmaceutical Professional, High Wycombe, UK

Lou Whelan
Managing Editor, The Journal Office, UK

Oxford Handbook of Clinical and Healthcare Research

Edited by Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and edited with assistance of Sarah Gibbings

Oxford Medical Handbooks

Reviews and Awards

"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