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Title A comprehensive and practical guide to clinical trials / edited by Delva Shamley, Brenda Wright, the Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa
Published London, United Kingdom : Academic Press, [2017]
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Description 1 online resource
Contents 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
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
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
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
Summary 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 practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide. Provides best practice elements, including case studies, practical examples, activities, and checklists
Bibliography Includes bibliographical references and index
Notes Vendor-supplied metadata
Subject Clinical trials -- Handbooks, manuals, etc.
Genre/Form Handbooks and manuals.
Handbooks and manuals.
Form Electronic book
Author Shamley, Delva, editor
Wright, Brenda, editor
ISBN 0128047305 (electronic bk.)
9780128047309 (electronic bk.)