The brand-new third edition of the Manual for Clinical Trials Nursing provides a more comprehensive guide for clinical trials nurses of all levels of experience and practice settings. With expanded content and reorganized chapters to facilitate location of desired content, the book covers topics ranging from history and fundamental information through protocol development and financial factors, recruitment and retention, clinical trial participants, and genetics and genomics to correlative trials, quality assurance, professional development, and international research efforts. Since clinical trials research is dynamic, the new edition directs the reader to pertinent websites where the most current information is available. -- Provided by publisher.

"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.

"This manual, the first of its kind focused on district nursing, provides the means to build competence and confidence in nurses new to the community, or developing their skills. The comprehensive and evidence-based content provides essential information for competence in key areas of district nursing." —From the Foreword, by Rosemary Cook CBE, Hon D Lett, MSc, PG Dip, RGN Director, The Queen's Nursing Institute Clinical skills are a fundamental aspect of district nursing care. The District Nursing Manual of Clinical Procedures is a practical, evidence-based manual of clinical skills which reflects the unique challenges of district nursing care within the patient's home. It provides a comprehensive resource for all district nurses, community nurses, students and healthcare professionals involved in the district nursing team, enabling them to practice competently and confidently and deliver clinically effective, person-centred care. The District Nursing Manual of Clinical Procedures addresses the complexity of district nursing care and encompasses key aspects of clinical practice, including decision making in areas that district and community nurses often struggle with or find difficult when they are on their own in a patient's home. It utilises the latest clinical research and expert clinical knowledge to address these challenges, and to provide the underlying theory and evidence for district nursing care. Key features Evidence-based manual of practical clinical skills in district nursing care Clear, user-friendly and easy to understand Contains recommendations for expert care within a patient's own home Addresses key concerns of district and community nurses working on their own within a patient's home Encompasses key aspects of district nursing care Placed in the context of person-centred care All procedures include the rationale for each action - 'why' as well as 'how' This title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from iTunes, Google Play or the MedHand Store.

This guide to conducting clinical research emphasizes elements that are important for patient safety and investigator survival. Stone provides an overview of how research is conducted for drug companies and how to become involved in it, as well as career opportunities in medical research. She explains how sites attract studies, preparation, audits and regulatory requirements, recruiting volunteers for a study and implementing the protocol, career development, and ethics, politics, and social issues, including aspects relating to race, gender, and religion. Worksheets, forms, and supplementary information are provided in the extensive appendices. The guide is mostly aimed at physicians, but can be of use to nurses, study coordinators, and investigators. Stone is an internist and infectious disease specialist who has extensive experience in conducting clinical trials. Annotation ©2007 Book News, Inc., Portland, OR (booknews.co.