{"product_id":"global-clinical-trials-effective-implementation-and-management-paperback-9780128103555","title":"Global Clinical Trials; Effective Implementation and Management (Paperback) 9780128103555","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eGlobal Clinical Trials\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eEffective Implementation and Management\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cem\u003e\u003cp\u003eComprehensive guide to design and development of effective clinical trials around the world\u003c\/p\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eRichard Chin (Edited by), Menghis Bairu (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780128103555, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback, published 19 August 2016\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e522 pages\u003cbr\u003e22.9 x 15.1 x 3.2 cm, 0.86 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\"...can be considered a manual on how an ethical global clinical trial should be conducted....a landmark publication; it likely will stand as a standard reference book for global clinical trials for many years to come.\" --\u003cb\u003eJournal of the American Medical Association, May 2012\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\"Global Clinical Trials: Effective Implementation and Management? is probably the most comprehensive book written to date on the topic…The book includes contributions from 59 authors, with coverage of many countries engaged in clinical research.\" \u003cb\u003e--Journal of Clinical Research Best Practices, May 2012\u003c\/b\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003eThis 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eSection I: Overview  \u003c\/b\u003eChapter 1 Background  Chapter 2: Ethics Chapter 3: Regulatory and Legal Requirements Chapter 4: United States Regulations Chapter 5: Indian Regulations Chapter 6: Chinese Regulations Chapter 7: African Regulations Chapter 8: Middle Eastern Regulations Chapter 9: Southeast Asian Regulations Chapter 10: South American Regulations Chapter 11: WHO and prequalification\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection II: Clinical Study and Logistics \u003c\/b\u003eChapter 12: Design of Clinical Trials Chapter 13: Study Management Chapter 14: CRO Qualification, Selection, and Management Chapter 15: Logistics Chapter 16: Partner Management Chapter 17: Site Selection and Capacity Building Chapter 18: Study Conduct and Monitoring Chapter 19: Data Collection and Management     \u003cb\u003eSection III: Special Considerations in Conducting Trials in Developing Countries \u003c\/b\u003eChapter 20: Conducting Studies in India Chapter 21: Conducting Studies in China Chapter 22: Conducting Studies in Africa Chapter 23: Conducting Studies in Eastern Europe Chapter 24: Vaccine Trials\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection IV: Analysis of Results   \u003c\/b\u003eChapter 25: Basic Statistics     Chapter 26: Data Analysis   Chapter 27: Confounding, Interactions, and Multivariate Analysis     Chapter 28: Common Misinterpretations   Chapter 29: Regulatory Filings\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection V: Appendices   \u003c\/b\u003eAppendix A: Sample Protocol  Appendix B: Sample Consent Form   Appendix C: Sample Investigator’s Brochure   Appendix C: Sample Case Report Form   Appendix D: Sample Statistical Analysis Plan   Appendix D: ICH Guideline   Appendix E: Glossary\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Genetics [\u003ca title=\"See our other books on Genetics\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Genetics%20%5Bnon-medical%5D%20%5BPSAK%5D%22\"\u003enon-medical PSAK\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Academic Press","offers":[{"title":"Default Title","offer_id":46649064685848,"sku":"9780128103555","price":79.58,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780128103555.jpg?v=1694096939","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/global-clinical-trials-effective-implementation-and-management-paperback-9780128103555","provider":"Freshly Printed Books","version":"1.0","type":"link"}