Show Summary Details
- Foreword
- Preface
- Acknowledgements
- Contributors
- Symbols and abbreviations
- Chapter 1 Research: why and how?
- Chapter 2 Navigating research methods: basic concepts in biostatistics and epidemiology
- Chapter 3 Navigating research methods: quantitative and clinical/epidemiological methods
- Chapter 4 Navigating research methods: qualitative methods
- Chapter 5 Navigating research methods: evidence-based medicine (EBM)
- Chapter 6 Navigating research methods: critical appraisal
- Chapter 7 Navigating research methods: clinical audit
- Chapter 8 Setting the scene and ICH GCP in clinical and healthcare research
- Chapter 9 Informed consent in a research setting
- Chapter 10 Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act
- Chapter 11 Role and responsibilities: investigator and research team
- Chapter 12 Role and responsibilities of the sponsor
- Chapter 13 Monitoring
- Chapter 14 Clinical trial design
- Chapter 15 Clinical trial protocols: study protocol
- Chapter 16 Data capture tools: case report form (CRF)
- Chapter 17 Clinical trial supplies: investigational medicinal products (IMPs)
- Chapter 18 IMP accountability
- Chapter 19 Safety reporting
- Chapter 20 Data management
- Chapter 21 Research project management
- Chapter 22 Essential documents
- Chapter 23 Archiving
- Chapter 24 Audits and inspections
- Chapter 25 Fraud and misconduct
- Chapter 26 Authorship
- Chapter 27 Publication process
- Chapter 28 Start-up toolkit: from funding an idea, through implementation, to achieving an impact
- Index
(p. 367) IMP accountability
(p. 367)
IMP accountability
- Chapter:
- (p. 367) IMP accountability
- DOI:
- 10.1093/med/9780199608478.003.0018
Why is drug accountability needed? - What does IMP accountability involve? - Local GMP activities - Documents and forms
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- Foreword
- Preface
- Acknowledgements
- Contributors
- Symbols and abbreviations
- Chapter 1 Research: why and how?
- Chapter 2 Navigating research methods: basic concepts in biostatistics and epidemiology
- Chapter 3 Navigating research methods: quantitative and clinical/epidemiological methods
- Chapter 4 Navigating research methods: qualitative methods
- Chapter 5 Navigating research methods: evidence-based medicine (EBM)
- Chapter 6 Navigating research methods: critical appraisal
- Chapter 7 Navigating research methods: clinical audit
- Chapter 8 Setting the scene and ICH GCP in clinical and healthcare research
- Chapter 9 Informed consent in a research setting
- Chapter 10 Ethics of clinical and healthcare research: general considerations, Mental Capacity Act, Human Tissue Act
- Chapter 11 Role and responsibilities: investigator and research team
- Chapter 12 Role and responsibilities of the sponsor
- Chapter 13 Monitoring
- Chapter 14 Clinical trial design
- Chapter 15 Clinical trial protocols: study protocol
- Chapter 16 Data capture tools: case report form (CRF)
- Chapter 17 Clinical trial supplies: investigational medicinal products (IMPs)
- Chapter 18 IMP accountability
- Chapter 19 Safety reporting
- Chapter 20 Data management
- Chapter 21 Research project management
- Chapter 22 Essential documents
- Chapter 23 Archiving
- Chapter 24 Audits and inspections
- Chapter 25 Fraud and misconduct
- Chapter 26 Authorship
- Chapter 27 Publication process
- Chapter 28 Start-up toolkit: from funding an idea, through implementation, to achieving an impact
- Index