- 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. 185) Role and responsibilities of the sponsor
- Chapter:
- (p. 185) Role and responsibilities of the sponsor
- DOI:
- 10.1093/med/9780199608478.003.0012
This chapter discusses the definitions of a clinical trial sponsor and the roles and responsibilities that it comprises. The aim is to give an overall picture of the role and legal responsibilities and to focus on the systems required for successfully undertaking the role of sponsor. The sponsor is critical, as without a sponsor, a study may not proceed. Sponsor responsibilities are very broad, encompassing overall responsibility for many different trial related activities. These are detailed in GCP guidelines, the EU Directives, the EU Regulation and national regulations. Key areas include authorisations/approvals (including indemnity, insurance and compensation arrangements), financing of the study, conduct of the study to GCP standards, provision of quality systems including SOPs and auditing, manufacture and provision of investigational medicinal product and safety information. Sponsors will therefore require systems to cover these key areas. While activities may be delegated, the sponsor retains overall responsibility, so adequate oversight is required to ensure that these activities are completed to appropriate standards.
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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