LEADER 00000cam  2200649Ii 4500 
001    989872320 
003    OCoLC 
005    20191108044434.5 
006    m     o  d         
007    cr cnu|||unuuu 
008    170612s2017    enk     obf   001 0 eng d 
020    9780128047309|q(electronic bk.) 
020    0128047305|q(electronic bk.) 
020    |z9780128047293 
020    |z0128047291 
035    (OCoLC)989872320|z(OCoLC)990021487|z(OCoLC)990501871 
035    ScienceDirect All Books 
035    skip4alma 
040    N$T|beng|erda|epn|cN$T|dN$T|dYDX|dIDEBK|dEBLCP|dOPELS
049    txum 
050  4 R853.C55eb 
072  7 HEA|x012000|2bisacsh 
072  7 HEA|x020000|2bisacsh 
072  7 MED|x004000|2bisacsh 
072  7 MED|x101000|2bisacsh 
072  7 MED|x109000|2bisacsh 
072  7 MED|x029000|2bisacsh 
072  7 MED|x040000|2bisacsh 
072  7 MED|x092000|2bisacsh 
245 02 A comprehensive and practical guide to clinical trials /
       |cedited by Delva Shamley, Brenda Wright, the Clinical 
       Research Centre at the University of Cape Town, Cape Town,
       Western Cape Province, South Africa. 
264  1 London, United Kingdom :|bAcademic Press,|c[2017] 
300    1 online resource 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
504    Includes bibliographical references and index. 
505 0  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. 
505 8  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. 
505 8  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. 
505 8  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. 
505 8  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. 
506    Available only to authorized UTEP users. 
520    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. 
588 0  Vendor-supplied metadata. 
650  0 Clinical trials|vHandbooks, manuals, etc. 
655  7 Handbooks and manuals.|2fast|0(OCoLC)fst01423877 
700 1  Shamley, Delva,|eeditor. 
700 1  Wright, Brenda,|eeditor. 
776 08 |iPrint version:|z9780128047293|z0128047291
856 40 |uhttp://0-www.sciencedirect.com.lib.utep.edu/science/book
       /9780128047293|zTo access this resource 
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