000795995 000__ 04633cam\a2200457Ii\4500
000795995 001__ 795995
000795995 005__ 20210515133933.0
000795995 006__ m\\\\\o\\d\\\\\\\\
000795995 007__ cr\cn\nnnunnun
000795995 008__ 170612s2017\\\\enk\\\\\ob\\\\001\0\eng\d
000795995 020__ $$a9780128047309$$q(electronic book)
000795995 020__ $$a0128047305$$q(electronic book)
000795995 020__ $$z9780128047293
000795995 020__ $$z0128047291
000795995 035__ $$a(NhCcYBP)EBC4873523
000795995 040__ $$aNhCcYBP$$cNhCcYBP
000795995 050_4 $$aR853.C55
000795995 08204 $$a610.72/4$$223
000795995 24502 $$aA comprehensive and practical guide to clinical trials /$$cedited by Delva Shamley, Brenda Wright, the Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa.
000795995 264_1 $$aLondon, United Kingdom :$$bAcademic Press,$$c[2017]
000795995 300__ $$a1 online resource.
000795995 336__ $$atext$$btxt$$2rdacontent
000795995 337__ $$acomputer$$bc$$2rdamedia
000795995 338__ $$aonline resource$$bcr$$2rdacarrier
000795995 504__ $$aIncludes bibliographical references and index.
000795995 5050_ $$aFront Cover; A Comprehensive and Practical Guide to Clinical Trials; Copyright Page; Contents; List of Contributors; Foreword; 1 Introduction to Clinical Trials; What Is a Clinical Trial?; Why Do We Do Clinical Trials?; Clinical Team; Study Participant; Medicines Regulatory Authorities; IRB/IEC Ethics Committees; Sponsor; Contract Research Organizations; Managing the Trial; Further Reading; 2 Clinical Trial Phases; Phase I; Proof-of-Concept Trials; Phase IIa and Phase IIb; Phase IIa; Phase IIb; Phase IIIa and Phase IIIb; Phase IIIa; Phase IIIb; Phase IV; Further Reading
000795995 5058_ $$a3 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
000795995 5058_ $$aThe United StatesEMA; The United Kingdom; Australia; China; India; 5 Contracts and Agreements; Clinical Trial Agreement/Site Agreement; Parties to the Agreement; Study Details; Compliance; Timelines; Data Confidentiality and Safe and Secure Storage of Data; Data Intellectual Property Must be Described; Indemnity and Compensation; Insurance; Termination; General; Payment; Some Examples of Other Contracts; Cosponsorship Agreement; Funding Agreement; Collaboration Agreements; Intellectual Property Agreements; Service Level Agreements; Material Transfer Agreements; Pharmacy Technical Agreements
000795995 5058_ $$aFurther 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
000795995 5058_ $$aAppendix 7.5 Study BudgetAppendix 7.6 Staff Work Schedule; Appendix 7.7 Stock List; Appendix 7.8 Emergency Trolley Checklist; Appendix 7.9 Status Report; 8 Recruitment and Retention; Recruitment; Motivations for Participating in a Clinical Trial; Why Participants Will not Join; Recruitment Challenges; Recruitment Options; Achieving Recruitment Targets; Retention; Signs of Potential Nonadherence; Reasons for Resistance; Useful Tips for Participant Retention; Further Reading; 9 Training; Internal Training; External Training; Further Reading; 10 Data Management; Establish Compliance Requirements
000795995 506__ $$aAccess limited to authorized users
000795995 533__ $$aElectronic reproduction.$$bAnn Arbor, MI$$nAvailable via World Wide Web.
000795995 5880_ $$aVendor-supplied metadata.
000795995 650_0 $$aClinical trials$$vHandbooks, manuals, etc.
000795995 7001_ $$aShamley, Delva,$$eeditor.
000795995 7001_ $$aWright, Brenda,$$eeditor.
000795995 7102_ $$aProQuest (Firm)
000795995 77608 $$cOriginal$$z9780128047293$$z0128047291
000795995 852__ $$bebk
000795995 85640 $$3GOBI DDA$$uhttps://univsouthin.idm.oclc.org/login?url=http://ebookcentral.proquest.com/lib/usiricelib-ebooks/detail.action?docID=4873523$$zOnline Access
000795995 909CO $$ooai:library.usi.edu:795995$$pGLOBAL_SET
000795995 980__ $$aEBOOK
000795995 980__ $$aBIB
000795995 982__ $$aEbook
000795995 983__ $$aOnline