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Global Clinical Trials

Effective Implementation and Management

Specificaties
Paperback, blz. | Engels
Elsevier Science | e druk, 2016
ISBN13: 9780128103555
Rubricering
Elsevier Science e druk, 2016 9780128103555
€ 114,94
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Samenvatting

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials.

Specificaties

ISBN13:9780128103555
Taal:Engels
Bindwijze:Paperback

Inhoudsopgave

<p>Section I: Overview <br>Chapter 1 Background <br>Chapter 2: Ethics<br>Chapter 3: Regulatory and Legal Requirements<br>Chapter 4: United States Regulations<br>Chapter 5: Indian Regulations<br>Chapter 6: Chinese Regulations<br>Chapter 7: African Regulations<br>Chapter 8: Middle Eastern Regulations<br>Chapter 9: Southeast Asian Regulations<br>Chapter 10: South American Regulations<br>Chapter 11: WHO and prequalification</p> <p>Section II: Clinical Study and Logistics<br>Chapter 12: Design of Clinical Trials<br>Chapter 13: Study Management<br>Chapter 14: CRO Qualification, Selection, and Management<br>Chapter 15: Logistics<br>Chapter 16: Partner Management<br>Chapter 17: Site Selection and Capacity Building<br>Chapter 18: Study Conduct and Monitoring<br>Chapter 19: Data Collection and Management  <br> <br>Section III: Special Considerations in Conducting Trials in Developing Countries<br>Chapter 20: Conducting Studies in India<br>Chapter 21: Conducting Studies in China<br>Chapter 22: Conducting Studies in Africa<br>Chapter 23: Conducting Studies in Eastern Europe<br>Chapter 24: Vaccine Trials</p> <p>Section IV: Analysis of Results  <br>Chapter 25: Basic Statistics    <br>Chapter 26: Data Analysis  <br>Chapter 27: Confounding, Interactions, and Multivariate Analysis    <br>Chapter 28: Common Misinterpretations  <br>Chapter 29: Regulatory Filings</p> <p>Section V: Appendices  <br>Appendix A: Sample Protocol <br>Appendix B: Sample Consent Form  <br>Appendix C: Sample Investigator’s Brochure  <br>Appendix C: Sample Case Report Form  <br>Appendix D: Sample Statistical Analysis Plan  <br>Appendix D: ICH Guideline  <br>Appendix E: Glossary</p>
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Levertijd ongeveer 8 werkdagen

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        Global Clinical Trials