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
Show moreThis 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
Show more1: 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
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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