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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 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.
"Advances in technology, research, and evidence-based practice have led to improvements in the care of patients receiving radiation therapy. The knowledge and expertise required by nurses must focus on the needs of patients who come into their care at any point across the trajectory of the cancer journey. Nurses may work with patients at varying stages of the radiation therapy process and in a wide range of settings. Regardless, however, the need to be knowledgeable about the symptoms and side effects associated with this treatment is essential for nurses caring for this patient population. The Oncology Nursing Society has published the fifth edition of Manual for Radiation Oncology Nursing Practice and Education to support nurses who care for patients who will receive, are receiving, or have received radiation therapy. The fifth edition features significant updates and changes to the content to reflect advances in technology, treatment options, and symptom manage¬ment. New sections have been added based on input from radiation oncology nurses or as a result of changes in treatment options, the needs of specific patient populations, and observations from clinical practice. New topics include patients with cognitive changes and dementia; general distress and coping; patients with mental illness; special populations, such as women who are pregnant, ado-lescents, and young adults; special needs related to late effects of treatment and cardiac toxicities; and treatment modalities, includ¬ing cobalt therapy and immunotherapy. This manual serves as an essential resource for individual nurses new to working in a radiation therapy set¬ting as well as to nurses wanting to advance their knowledge in radiation biology and protection, diverse radiation therapy modalities, combination treatments, site- or disease-specific concerns, symptom management, special populations, and care during transition points. Additionally, this manual can be a resource to advanced practice clinicians, educators, and administrators, with a focus on support for nursing staff seeking the education and skills required to care for patients receiving radiation therapy and their families"--
Provides a practical approach to understanding the components of a clinical research trial as well as the tools to conduct a well-organized study. Designed for those interested in developing or enhancing skills to coordinate all aspects of clinical trials such as regulatory requirements, budgeting, contracts, patient recruitments and participation, and gathering and recording clear, invaluable data.
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
The Evidence-based Practice Manual successfully breaks down the skills for evidence-based nursing into manageable components. The reader will learn how to find, critically read and interpret a range of research studies, and will discover optimal approaches to helping patients reach decisions that are informed by the best-available evidence. The more-strategic concepts of developing an organisational evidence-based culture and making evidence-based changes at organisational level are the focus of the final section. Step-by-step guide to finding, appraising and applying research evidence in nursing Teaches skills for successfully reviewing published literature: formulating a focused question developing a search strategy for efficient retrieval of relevant studies appraising the retrieved studies All examples are relevant to nurses and nursing Reflects contemporary nursing issues A new chapter on ‘Using research evidence in making clinical decisions with the individual patient’ provides practical guidance and tools for decision-making A new chapter on ‘Using evidence from qualitative studies’ explains the complexities of qualitative methodologies and methods in a simple, easily understood way Online exercises and solutions Help the reader test out and consolidate newly acquired skills and knowledge Provide an opportunity to critically appraise studies with the following range of designs: qualitative research a randomised controlled trial a cohort study a case control study a diagnostic test accuracy study a systematic review a clinical guideline Example solutions are provided, all written by experts in the field.