The Sourcebook For Clinical Research
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| Author | : Natasha Martien |
| Publisher | : Academic Press |
| Total Pages | : 278 |
| Release | : 2018-08-01 |
| Genre | : Medical |
| ISBN | : 0128162430 |
A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. - Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) - Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process - Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits - Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. - Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject's needs urgently and compliantly
| Author | : Melvyn R. Werbach |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2000 |
| Genre | : Alternative medicine |
| ISBN | : 9781891710001 |
| Author | : JoAnn Pfeiffer |
| Publisher | : CRC Press |
| Total Pages | : 292 |
| Release | : 2017-05-18 |
| Genre | : Mathematics |
| ISBN | : 1315299771 |
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.
| Author | : P. Michael Dubinsky |
| Publisher | : John Wiley & Sons |
| Total Pages | : 554 |
| Release | : 2022-01-26 |
| Genre | : Medical |
| ISBN | : 1118949595 |
This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
| Author | : John I. Gallin |
| Publisher | : Elsevier |
| Total Pages | : 447 |
| Release | : 2011-04-28 |
| Genre | : Science |
| ISBN | : 0080489567 |
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
| Author | : Deborrah Norris |
| Publisher | : Plexus Publishing (UK) |
| Total Pages | : 164 |
| Release | : 2004 |
| Genre | : Design |
| ISBN | : |
In this revised third edition of the essential reference for clinical research coordinators (CRCs), Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, a glossary, and more.
| Author | : Michael Clinton Perry |
| Publisher | : Lippincott Williams & Wilkins |
| Total Pages | : 820 |
| Release | : 2008 |
| Genre | : Medical |
| ISBN | : 9780781773287 |
The Chemotherapy Source Book, Fourth Edition pulls together all the current information on the chemotherapeutic management of cancer patients, including choice of chemotherapeutic agents, use of combinations, and toxicity of individual drugs. Organized by disease site, the book brings together pharmacologic and patient management information in one source that clinicians can consult for any question encountered in the delivery of chemotherapy. This updated Fourth Edition includes new drugs as well as new indications for older drugs. Content has been streamlined to provide essential information more quickly for the busy practitioner. Plus, this edition is softcover for greater portability and convenience.
| Author | : Allan Hackshaw |
| Publisher | : John Wiley & Sons |
| Total Pages | : 184 |
| Release | : 2011-09-07 |
| Genre | : Medical |
| ISBN | : 1444356666 |
Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies
| Author | : Debra L. Worthington |
| Publisher | : John Wiley & Sons |
| Total Pages | : 841 |
| Release | : 2017-08-09 |
| Genre | : Family & Relationships |
| ISBN | : 1119102960 |
Winner of the 2018 Distinguished Book Award from the Communication and Social Cognition Division of the National Communication Association. Essential reading for listening researchers across a range of disciplines, The Sourcebook of Listening Research: Methodology and Measures is a landmark publication that defines the field of listening research and its best practices. the definitive guide to listening methodology and measurement with contributions from leading listening scholars and researchers Evaluates current listening methods and measures, with attention to scale development, qualitative methods, operationalizing cognitive processes, and measuring affective and behavioral components A variety of theoretical models for assessing the cognitive, affective, and behavioral facets of listening are presented alongside 65 measurement profiles Outlines cutting-edge trends in listening research, as well as the complexities involved in performing successful research in this area
| Author | : David A. Jobes |
| Publisher | : Guilford Publications |
| Total Pages | : 290 |
| Release | : 2016-06-20 |
| Genre | : Psychology |
| ISBN | : 1462526918 |
This book has been replaced by Managing Suicidal Risk, Third Edition, ISBN 978-1-4625-5269-6.
