- 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. 297) Clinical trial protocols: study protocol
- Chapter:
- (p. 297) Clinical trial protocols: study protocol
- DOI:
- 10.1093/med/9780199608478.003.0015
This chapter defines protocols and the requirements to be considered when writing a protocol, The protocol is one of the most important documents and must be clear, concise and well written. The chapter describes the procedures before embarking on writing a protocol, who should be involved and describes all the main elements to be included. The ICH E6 guidelines give a complete list of the content of a protocol so this chapter centres on the main decisions/considerations. The main considerations are outlined in a skeleton protocol which includes for example objectives and end points, subject population, study design, study methodology, assessments and timings and statistical considerations. Once these main decisions have been made the first full draft protocol can be written by elaborating every detail and adding the administrative sections as set out in the company/institution SOPs and the ICH GCP guidelines. The process of protocol approval is described along with the requirements for protocol amendments. The additional requirements to be considered in writing protocols for healthcare studies is set out especially the ethical requirements that have to be addressed.
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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