"The 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 Description: Book by Davis, Kate

Profiles a woman who is remembered for her intellectual accomplishments, belief in womens' rights, and support of her husband, John, who became the second president of the United States.

A biography of Thomas Paine, who spent his youth in England but became a hero of the American and French revolutions by writing books and pamphlets which embodied the ideals of freedom, equality, and democracy.

An introduction to the Cabinet-level post of Secretary of the Interior, discussing the selection of the Secretary, duties, organizational structure, as well as a sample day's responsibilities.

A biography of the patriot, Samuel Adams, from his religious upbringing and education to his important role in the American Revolution. (view table of contents)

Product Description: Book by Kate Davis; Cd Hullinger

The puzzle blocks make pictures related to various occupations, to be matched with the text in the board book.

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Product Description: Who hops and flies and slithers and swims and crawls? In this simple, colorful story, toddlers will find the answer. Now available for the first time, this Spanish-language board book edition of Who Hops? is the perfect read-aloud tale for a whole new audience of hopping children...read more

Product Description: Plush Board Book