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E-raamat: Comprehensive and Practical Guide to Clinical Trials

Edited by (Directer, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Province, South Africa), Edited by (Operations Manager: Pharma-Lead Projects, Clinical Research Center, University of Cape Town, Cape Town, Western Cape Provinc)
  • Formaat: PDF+DRM
  • Ilmumisaeg: 07-Jun-2017
  • Kirjastus: Academic Press Inc
  • Keel: eng
  • ISBN-13: 9780128047309
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Comprehensive and Practical Guide to Clinical TrialsSuurem pilt
  • Formaat: PDF+DRM
  • Ilmumisaeg: 07-Jun-2017
  • Kirjastus: Academic Press Inc
  • Keel: eng
  • ISBN-13: 9780128047309
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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. This book offers those involved in clinical research a clear understanding of how all of 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 on their team. 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
  • Includes best practice elements, including case studies, practical examples, activities and checklists
  • Accompanied by a website with powerpoint slides and an image bank

Muu info

A quick reference guide with tools and case studies that enable effective planning and implementation of clinical trials
List of Contributors
xi
Foreword xiii
1 Introduction to Clinical Trials
Brenda Wright
What Is a Clinical Trial?
1(1)
Why Do We Do Clinical Trials?
1(2)
Clinical Team
3(1)
Study Participant
3(1)
Medicines Regulatory Authorities
3(1)
IRB/IEC Ethics Committees
4(1)
Sponsor
4(1)
Contract Research Organizations
5(1)
Managing the Trial
5(4)
Further Reading
9(3)
2 Clinical Trial Phases
Brenda Wright
Phase I
12(1)
Proof-of-Concept Trials
12(1)
Phase IIa and Phase lib
12(1)
Phase IIa
13(1)
Phase IIb
13(1)
Phase IIIa and Phase IIIb
13(1)
Phase IIIa
14(1)
Phase IIIb
14(1)
Phase IV
14(1)
Further Reading
15(3)
3 Setting Up of Site, Site Assessment Visits, and Selection
Brenda Wright
Setting Up of Site
18(2)
Feasibility
20(1)
Site Assessment Visits
20(4)
Site Selection Criteria
20(1)
Site Visits
21(3)
Key Questions to Ask
24(1)
Further Reading
25(1)
Appendix 3.1 Site Assessment Visit Checklist
26(7)
4 Regulatory Requirements
Inge Vermeulen
IRB/IEC Ethics Committees
33(1)
South Africa (MCC, HREC, Provincial/Hospital)
33(2)
The United States (FDA, IRB)
35(1)
Europe (EMA, IRB)
36(1)
The United Kingdom (MHRA, HRA)
36(1)
Australia (TGA HREC, Institution/Organizational Approval)
37(1)
China (CFDA, CDE, Hospital/Institution, IRB)
38(1)
India (DCGI, CDSCO, IEC)
39(1)
Conclusion
40(1)
Further Reading
41(3)
5 Contracts and Agreements
Brenda Wright
Clinical Trial Agreement/Site Agreement
44(2)
Parties to the Agreement
44(1)
Study Details
44(1)
Compliance
44(1)
Timelines
44(1)
Data Confidentiality and Safe and Secure Storage of Data
45(1)
Data Intellectual Property Must be Described
45(1)
Indemnity and Compensation
45(1)
Insurance
45(1)
Termination
45(1)
General
45(1)
Payment
46(1)
Some Examples of Other Contracts
46(1)
Cosponsorship Agreement
46(1)
Funding Agreement
46(1)
Collaboration Agreements
46(1)
Intellectual Property Agreements
46(1)
Service Level Agreements
47(1)
Material Transfer Agreements
47(1)
Pharmacy Technical Agreements
47(1)
Further Reading
47(2)
6 Protocol, Informed Consent Documents, and Investigator Brochure
Brenda Wright
Protocol
49(5)
Informed Consent
54(2)
Investigator Brochure
56(2)
Reference
58(1)
Further Reading
58(2)
7 Planning
Brenda Wright
Schedule of Events
60(1)
Design a Pretrial Checklist
60(1)
Draw Up a Trial Calendar
60(1)
Compile a Trial Budget
60(1)
Design a Staff Work Schedule
61(1)
Do Stock List for Equipment and Consumables
61(1)
Ensure That an Emergency Trolley/Crash Cart Is in Place Before You Start
62(1)
Compile a Weekly Updated Status Report
62(2)
Further Reading
64(1)
Appendix 7.1 Case Study
64(2)
Appendix 7.2 Schedule of Events
66(2)
Appendix 7.3 Prestudy Checklist
68(1)
Appendix 7.4 Study Calendar
69(3)
Appendix 7.5 Study Budget
72(2)
Appendix 7.6 Staff Work Schedule
74(2)
Appendix 7.7 Stock List
76(1)
Appendix 7.8 Emergency Trolley Checklist
77(2)
Appendix 7.9 Status Report
79(2)
8 Recruitment and Retention
Brenda Wright
Recruitment
81(3)
Motivations for Participating in a Clinical Trial
81(1)
Why Participants Will not Join
82(1)
Recruitment Challenges
82(1)
Recruitment Options
83(1)
Achieving Recruitment Targets
83(1)
Retention
84(2)
Signs of Potential Nonadherence
84(1)
Reasons for Resistance
84(1)
Useful Tips for Participant Retention
85(1)
Further Reading
86(1)
9 Training
Brenda Wright
Internal Training
87(1)
External Training
88(2)
Further Reading
90(2)
10 Data Management
Annemie Stewart
Establish Compliance Requirements
92(2)
Legislation and Regulatory Authorities
93(1)
Good Clinical Practice/Ethical Considerations
93(1)
Site-Specific Rules
93(1)
Funder/Sponsor Requirements
94(1)
Consider Sites and Logistics
94(1)
Source
94(1)
Case Report Form
94(1)
Database Design and Build
95(3)
Structure/Design
95(1)
Software Selection
95(1)
Building/Development
96(1)
Alpha Testing
97(1)
Beta Testing
97(1)
User Acceptance
97(1)
Third-Party Data
97(1)
Implement
98(2)
Data Entry
98(1)
Source Verification
98(1)
Data Resolution
99(1)
Backup
99(1)
Database Lock
100(1)
Record Locking
100(1)
Record Signing
100(1)
Data Export
100(1)
Analyze
100(1)
Publish
100(1)
Academic/Industry Publications
100(1)
Final Report and Data Submissions to Regulators
101(1)
Data Sharing and Archive
101(1)
Curation Centers
101(1)
Repositories
101(1)
"Cloud"-Based and Local Archives
101(1)
Summary
102(1)
References
102(3)
11 Investigational Medicinal Product (IMP) Management
Wynand Smythe
Nicky Kramer
What to Do in the Planning Stages
105(2)
Accountability
107(1)
Risk-Adapted Approach to Accountability
107(1)
Specific Processes of Accountability
108(4)
Sourcing and Receiving
108(1)
Storage
109(1)
Dispensing
109(1)
Randomization
110(1)
Blinding
111(1)
Disposal
111(1)
Regulations Governing IMP Management
112(1)
Quality Assurance Systems
113(1)
Standard Operating Procedures
113(1)
Environmental Monitoring
113(1)
Technical Agreements
114(1)
Prestudy IMP Checklist
114(1)
Further Reading
115(1)
Appendix 11.1 Case Study: Investigational Medicinal Product (IMP) Management Considerations in an Early Phase Studies
116(9)
12 Collecting, Processing, and Shipment of Blood and Urine Samples
Brenda Wright
Further Reading
125(7)
13 Source Document
Brenda Wright
Further Reading
132(1)
14 Screening, Treatment, and Safety Follow-up Visit
Brenda Wright
Screening Period
133(3)
Treatment Period
136(1)
Day --- 1
136(1)
Day 1
136(1)
Safety Follow-up Visit (End of Treatment Visit)
137(1)
Further Reading
137(1)
Appendix 14.1 Delegation Log
138(1)
Appendix 14.2 Informed Consent Process Source Document
139(2)
Appendix 14.3 Screening Visit Source Document
141(2)
Appendix 14.4 Eligibility Source Document
143(2)
Appendix 14.5 Preadmission Checklist
145(1)
Appendix 14.6 Adverse Event Source Document
146(1)
Appendix 14.7 Concomitant Medication Source Document
147(3)
Appendix 14.8 Day 1 Source Document
150(4)
Appendix 14.9 Follow-up Source Document
154(3)
15 Quality Management
Brenda Wright
Name of Trial Site
157(5)
Quality Management Plan --- Policies and Procedures
157(5)
Quality Assurance and Quality Control
162(5)
Quality Control
162(1)
Quality Assurance
163(1)
Document Management, Record Retention, and Reporting
164(1)
Corrective Action and Preventive Action
164(1)
Quality Risk Management
164(2)
Quality Roles and Responsibilities
166(1)
Further Reading
167(1)
Appendix 15.1 Delegation Log
168(1)
Appendix 15.2 Training Log
169(1)
Appendix 15.3 Quality Check Log
169(1)
Appendix 15.4 Case Report Form Data Entry Log
170(1)
Appendix 15.5 Regulatory Tracking Log
170(1)
Appendix 15.6 Noncompliance Log
171(1)
Appendix 15.7 Noncompliance Report
172(1)
Appendix 15.8 Risk Assessment
173(2)
16 Monitoring, Close-Out Visits, and Archiving
Brenda Wright
Monitoring
175(4)
Purpose of Monitoring
175(1)
Responsibilities of the Monitor
176(1)
Preparing for a Monitor Visit
176(3)
Further Reading
179(2)
17 Audits and Inspections
Brenda Wright
Audits
181(1)
Inspections
181(1)
Preparing for Audits and Inspections
181(2)
Further Reading
183(2)
Glossary 185(4)
Index 189
Dr Delva Shamley is a South African graduate and has been in academia for 26 years, 13 of which were spent in the UK. Her training and experience of clinical research comes from Oxford NHS and the Centre for Medical Statistics, Oxford University, UK. Delva has been training and supporting clinicians in Research Methods for many years. She returned to Cape Town in 2011 and started as Deputy Director of the UCT CRC in October of 2013. She has since been appointed as the Director for CRC. Brenda Wright (Registered Nurse/Medical Technician) started her career in Research at an Early Phase Unit in George in 2005. There she gained experience as study coordinator, Manager Clinical Planning, Manager Transit Laboratory and Clinical Trial Assistants. Experience includes: Healthy Volunteer, Bio-equivalent, First into Human, Restless Legs, Parkinsons disease, Alzheimers disease, Schizophrenia, Diabetes, COPD, Asthma, Osteo Arthritis, Rheumatoid arthritis, various skin diseases, TB, HIV, Sickle Cell in children and adolescents and Cancer. Brenda joined the CRC in April 2014 as Project Manager and the Research Facility Ward Manager. She has since been appointed as Operations Manager: Pharma-Lead Projects.
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