The editors (of U. Hospitals of Cleveland and Rx Trials, Inc.) offer a guide to the practical and ethical issues in the conduct of clinical research coordinators that places the topic in broad international perspective by including approaches from the European Union, Japan, Canada, and the United States. Thirteen chapters discuss ethics and human subjects protection, responsible conduct, the informed consent process, pediatric informed consent and assent, study implementation and start-up, recruitment and retention of research subjects, documentation, quality assurance in clinical trials, communication, education and training, and future trends in professionalization. Distributed in the US by BookMasters. Annotation ©2006 Book News, Inc., Portland, OR (booknews.com)
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Carol A Fedor is a clinical research manager at the Center for Clinical Research, University Hospitals of Cleveland, Ohio, USA; Philip A Cola is Director of the Division of Clinical Research at the Center for Clinical Research, University Hospitals of Cleveland, Ohio, USA; Christine Pierre is President of Rx Trials, Inc., Silver Springs, Maryland, USA.
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