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A comprehensive and practical guide to clinical trials /
A Comprehensive and practical guide to clinical trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the pract...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London, United Kingdom :
Academic Press,
[2017]
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; A Comprehensive and Practical Guide to Clinical Trials; Copyright Page; Contents; List of Contributors; Foreword; 1 Introduction to Clinical Trials; What Is a Clinical Trial?; Why Do We Do Clinical Trials?; Clinical Team; Study Participant; Medicines Regulatory Authorities; IRB/IEC Ethics Committees; Sponsor; Contract Research Organizations; Managing the Trial; Further Reading; 2 Clinical Trial Phases; Phase I; Proof-of-Concept Trials; Phase IIa and Phase IIb; Phase IIa; Phase IIb; Phase IIIa and Phase IIIb; Phase IIIa; Phase IIIb; Phase IV; Further Reading.
- 3 Setting Up of Site, Site Assessment Visits, and SelectionSetting Up of Site; Feasibility; Site Assessment Visits; Site Selection Criteria; Site Visits; Key Questions to Ask; Further Reading; Appendix 3.1 Site Assessment Visit Checklist; 4 Regulatory Requirements; IRB/IEC Ethics Committees; South Africa (MCC, HREC, Provincial/Hospital); The United States (FDA, IRB); Europe (EMA, IRB); The United Kingdom (MHRA, HRA); Australia (TGA, HREC, Institution/Organizational Approval); China (CFDA, CDE, Hospital/Institution, IRB); India (DCGI, CDSCO, IEC); Conclusion; Further Reading; South Africa.
- The United StatesEMA; The United Kingdom; Australia; China; India; 5 Contracts and Agreements; Clinical Trial Agreement/Site Agreement; Parties to the Agreement; Study Details; Compliance; Timelines; Data Confidentiality and Safe and Secure Storage of Data; Data Intellectual Property Must be Described; Indemnity and Compensation; Insurance; Termination; General; Payment; Some Examples of Other Contracts; Cosponsorship Agreement; Funding Agreement; Collaboration Agreements; Intellectual Property Agreements; Service Level Agreements; Material Transfer Agreements; Pharmacy Technical Agreements.
- Further Reading6 Protocol, Informed Consent Documents, and Investigator Brochure; Protocol; Informed Consent; Investigator Brochure; Reference; Further Reading; 7 Planning; Schedule of Events; Design a Pretrial Checklist; Draw Up a Trial Calendar; Compile a Trial Budget; Design a Staff Work Schedule; Do Stock List for Equipment and Consumables; Ensure That an Emergency Trolley/Crash Cart Is in Place Before You Start; Compile a Weekly Updated Status Report; Further Reading; Appendix 7.1 Case Study; Appendix 7.2 Schedule of Events; Appendix 7.3 Prestudy Checklist; Appendix 7.4 Study Calendar.
- Appendix 7.5 Study BudgetAppendix 7.6 Staff Work Schedule; Appendix 7.7 Stock List; Appendix 7.8 Emergency Trolley Checklist; Appendix 7.9 Status Report; 8 Recruitment and Retention; Recruitment; Motivations for Participating in a Clinical Trial; Why Participants Will not Join; Recruitment Challenges; Recruitment Options; Achieving Recruitment Targets; Retention; Signs of Potential Nonadherence; Reasons for Resistance; Useful Tips for Participant Retention; Further Reading; 9 Training; Internal Training; External Training; Further Reading; 10 Data Management; Establish Compliance Requirements.