A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons,

Description: About this productProduct InformationThe publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. -- Robert Harrington , Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.Product IdentifiersPublisherWiley & Sons, Incorporated, JohnISBN-101405195150ISBN-139781405195157eBay Product ID (ePID)78350941Product Key FeaturesAuthorMargaret Liu, Kate DavisPublication NameClinical Trials Manual from the Duke Clinical Research Institute : Lessons from a Horse Named JimFormatTrade PaperbackLanguageEnglishPublication Year2010TypeTextbookNumber of Pages426 PagesDimensionsItem Length9.7in.Item Height0.9in.Item Width6.8in.Item Weight29.2 OzAdditional Product FeaturesLc Classification NumberR853.C55l58 2010Edition Number2Reviews"This is an excellent guide to how to conduct clinical trials ofmedical devices and biologics in the light of recent regulatory andclinical developments. The roles and responsibilities ofinstitutional review boards and recent developments regardingsubject privacy concerns and regulations are well covered. Thismanual also provides sample forms and worksheets for datamanagement." (Doody's, 5 August 2011) "A Clinical Trials Manual from the Duke Clinical ResearchInstitute: Lessons from a Horse Named Jim, 2nd Edition" is a goodintroduction to clinical research, primarily from the siteperspective. The book gives readers a solid foundation ofprinciples and knowledge." (Journal of Clinical Research BestPractices, 8 August 2011), "This is an excellent guide to how to conduct clinical trials of medical devices and biologics in the light of recent regulatory and clinical developments. The roles and responsibilities of institutional review boards and recent developments regarding subject privacy concerns and regulations are well covered. This manual also provides sample forms and worksheets for data management." (Doody's, 5 August 2011) "A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition" is a good introduction to clinical research, primarily from the site perspective. The book gives readers a solid foundation of principles and knowledge." (Journal of Clinical Research Best Practices, 8 August 2011)eBook FormatUnspecifiedCopyright Date2010Target AudienceScholarly & ProfessionalTopicClinical Medicine, Preventive Medicine, Pharmacology, Health PolicyLccn2009-020427IllustratedYesGenreMedical

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