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Global clinical trials[electronic resource] :effective implementation and management /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615.5072/4
書名/作者:	Global clinical trials : effective implementation and management // Richard Chin, Menghis Bairu [editors].
其他作者:	Chin, Richard.
出版者:	Amsterdam ; : Academic Press,, c2011.
面頁冊數:	1 online resource (xx, 501 p., [13] p. of col. plates.)
附註:	Includes index.
標題:	Clinical trials - Developing countries.
標題:	Human experimentation in medicine - Developing countries.
ISBN:	9780123815378 (electronic bk.)
ISBN:	0123815371 (electronic bk.)
內容註:	Introduction Section I: Overview -- Section II: Clinical Study and Logistics -- Section III: Special Considerations in Conducting Trials in Developing Countries.
摘要、提要註:	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. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA.
電子資源:	http://www.sciencedirect.com/science/book/9780123815378

Global clinical trials[electronic resource] :effective implementation and management /
Global clinical trialseffective implementation and management /[electronic resource] :Richard Chin, Menghis Bairu [editors]. - Amsterdam ;Academic Press,c2011. - 1 online resource (xx, 501 p., [13] p. of col. plates.)

Includes index.

Introduction Section I: Overview -- Section II: Clinical Study and Logistics -- Section III: Special Considerations in Conducting Trials in Developing Countries.

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. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA.

ISBN: 9780123815378 (electronic bk.)

Source: 1097461:10918551Elsevier Science & Technologyhttp://www.sciencedirect.comSubjects--Topical Terms:

493502
Clinical trials
--Developing countries.Index Terms--Genre/Form:

336502
Electronic books.

LC Class. No.: R853.C55 / G56 2011

Dewey Class. No.: 615.5072/4

Global clinical trials[electronic resource] :effective implementation and management /
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520 $a 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. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA.
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