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.
Inhaltsverzeichnis
- 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
