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.
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 #1 Drug Guide for nurses & other clinicians...always dependable, always up to date! Look for these outstanding features: Completely updated nursing-focused drug monographs featuring 3,500 generic, brand-name, and combination drugs in an easy A-to-Z format NEW 32 brand-new FDA-approved drugs in this edition, including the COVID-19 drug remdesivir—tabbed and conveniently grouped in a handy “NEW DRUGS” section for easy retrieval NEW Thousands of clinical updates—new dosages and indications, Black Box warnings, genetic-related information, adverse reactions, nursing considerations, clinical alerts, and patient teaching information Special focus on U.S. and Canadian drug safety issues and concerns Photoguide insert with images of 439 commonly prescribed tablets and capsules
"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.
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Clinical skills are a fundamental aspect of nursing care of children and young people. The Great Ormond Street Hospital Manual of Children's Nursing Practices is an evidence-based manual of practical skills in children's nursing which builds on the extensive expertise developed at Great Ormond Street Hospital. It encompasses all aspects of children's nursing from the most basic aspects of everyday practice to advanced practice in high dependency and intensive care to provide a comprehensive resource for all qualified nurses, students, and other health-care professionals involved in caring for children, both in the hospital and the community setting. Children's and young people's nursing presents unique challenges. The Great Ormond Street Hospital Manual utilises the latest clinical research and expert clinical knowledge to address these challenges, and provides the underlying theory and evidence for nursing care of children. It provides a definitive guide to clinical skills procedures in children's and young people's nursing which enables nurses working with children and young people to practice confidently and deliver clinically effective family-centred care. Key features Offers access to clinical procedures developed through the extensive expertise from Great Ormond Street Hospital Contains evidence-based recommendations for expert care Encompasses all aspects of children's care Contains procedures guidelines students can rely on and effectively use in practice following qualfication Highlights specific needs of neonates and adolescents Placed in the context of inter-disciplinary care of the child Includes the rationale for each procedure - the 'why' as well as 'how' Information presented in a similar way to The Royal Marsden Manual of Clinical Nursing Procedures - offering continuity to those working in both adult and paediatric settings This title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from iTunes or the MedHand Store.
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Concise, portable, and packed with essential information, Manual of Clinical Oncology is an indispensable resource for understanding basic science, clinical findings, and available technology as they relate to the diagnosis and management patients with cancer. The practical format provides high-yield content useful for participating in rounds ad making diagnostic and therapeutic decisions at the bedside. Edited by Dr. Bartosz Chmielowski and Dr. Mary Territo, both from UCLA School of Medicine, this eighth edition carries on the tradition of excellence set forth by longtime editor Dr. Dennis Casciato. Incorporates recent major achievements in immunotherapies, biologics, and targeted therapies. Features new chapters on the biology of cancer, immunotherapy, and cancer survivorship. Contains numerous diagnostic and treatment algorithms, as well as content on complications, for assistance with clinical decision making. Includes helpful appendices such as a glossary of cytogenetic nomenclature and combination chemotherapy regimens. Your book purchase includes a complimentary download of the enhanced eBook for iOS, Android, PC & Mac. Take advantage of these practical features that will improve your eBook experience: The ability to download the eBook on multiple devices at one time — providing a seamless reading experience online or offline Powerful search tools and smart navigation cross-links that allow you to search within this book, or across your entire library of VitalSource eBooks Multiple viewing options that enable you to scale images and text to any size without losing page clarity as well as responsive design The ability to highlight text and add notes with one click
