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Guide For Principal Investigators
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Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Guide to the Principal Investigator of NCI Contracts by : National Cancer Institute (U.S.)
Download or read book Guide to the Principal Investigator of NCI Contracts written by National Cancer Institute (U.S.) and published by . This book was released on 1987 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Principal-Investigator-Led Missions in the Space Sciences by : National Research Council
Download or read book Principal-Investigator-Led Missions in the Space Sciences written by National Research Council and published by National Academies Press. This book was released on 2006-04-22 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principal Investigator-Led (PI-led) missions are an important element of NASA's space science enterprise. While several NRC studies have considered aspects of PI-led missions in the course of other studies for NASA, issues facing the PI-led missions in general have not been subject to much analysis in those studies. Nevertheless, these issues are raising increasingly important questions for NASA, and it requested the NRC to explore them as they currently affect PI-led missions. Among the issues NASA asked to have examined were those concerning cost and scheduling, the selection process, relationships among PI-led team members, and opportunities for knowledge transfer to new PIs. This report provides a discussion of the evolution and current status of the PIled mission concept, the ways in which certain practices have affected its performance, and the steps that can carry it successfully into the future. The study was done in collaboration with the National Academy of Public Administration.
Book Synopsis Navigating Tenure and Beyond by : Sundar Anand Christopher
Download or read book Navigating Tenure and Beyond written by Sundar Anand Christopher and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Career guidance, for those in meteorology or any other career.
Book Synopsis A Clinical Trials Manual From The Duke Clinical Research Institute by : Margaret Liu
Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Book Synopsis Principles and Practice of Clinical Trial Medicine by : Richard Chin
Download or read book Principles and Practice of Clinical Trial Medicine written by Richard Chin and published by Elsevier. This book was released on 2008-07-25 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy
Book Synopsis Evaluating the Science and Ethics of Research on Humans by : Dennis J. Mazur
Download or read book Evaluating the Science and Ethics of Research on Humans written by Dennis J. Mazur and published by Johns Hopkins University Press. This book was released on 2007-02-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research—institutional review boards, or IRBs—is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas—drugs, medical devices, and genetic information—Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.
Book Synopsis Institutional Review Board Member Handbook by : Robert J. Amdur
Download or read book Institutional Review Board Member Handbook written by Robert J. Amdur and published by Jones & Bartlett Publishers. This book was released on 2010-10-22 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Essential Resource for All IRB Members! Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. NEW CHAPTERS in this Edition Include: * Definition of Human Subject Research, Exempt & Expedited Review Categories * IRB Member Conflict of Interest All chapters are completely updated for 2010 practice! This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.
Book Synopsis Responsible Conduct of Research by : Adil E. Shamoo
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Book Synopsis Principles of Research Methodology by : Phyllis G. Supino
Download or read book Principles of Research Methodology written by Phyllis G. Supino and published by Springer Science & Business Media. This book was released on 2012-06-22 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.
Book Synopsis NIH Guide for Grants and Contracts by :
Download or read book NIH Guide for Grants and Contracts written by and published by . This book was released on 1991 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Grant Proposal Guide by : National Science Foundation (U.S.)
Download or read book Grant Proposal Guide written by National Science Foundation (U.S.) and published by . This book was released on 1994 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Ruth Jennifer Cavalieri Publisher :Nursing Knowledge International ISBN 13 :9781937554644 Total Pages :262 pages Book Rating :4.5/5 (546 download)
Book Synopsis Clinical Research Manual by : Ruth Jennifer Cavalieri
Download or read book Clinical Research Manual written by Ruth Jennifer Cavalieri and published by Nursing Knowledge International. This book was released on 2013 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Science of Intelligent Achievement by : Isaiah Hankel
Download or read book The Science of Intelligent Achievement written by Isaiah Hankel and published by John Wiley & Sons. This book was released on 2018-02-05 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: Smart strategies for pragmatic, science-based growth and sustainable achievement. The Science of Intelligent Achievement teaches you the scientific process of finding success through your most valuable assets: · Selective focus – how selective are you with who and what you let into your life? · Creative ownership – how dependent are you on others for your happiness and success? · Pragmatic growth – how consistently and practically are you growing daily? First, this book will show you how to develop your focus by being very selective with where you spend your mental energy. If you've failed to reach an important goal because you were distracted, misinformed, or overcommitted, then you know the role focus and selectivity play in achievement. Second, you will learn how to stop allowing your happiness and success to be dependent on other people and instead, start taking ownership over your life through creative work. Finally, you will learn the art of changing your life through pragmatic decisions and actions. Self-improvement is not the result of dramatic changes. Instead, science has shown that personal and professional change is initiated and sustained by consistent, practical changes. To grow, you must leverage the power of micro-decisions, personality responsibility, and mini-habits. Your own biology will not let you improve your life in any other way. What do you currently value? What are working to attain? Have you been taught to value your job title or your relationship with some other person above all else? Have you been convinced that the most valuable things in life are your paycheck, the number of people who say 'hello' to you at the office, and the number of people who say 'I need you' at home? Or, have you become so passive in what you value that you let anyone and anything into your life, as long as whatever you let in allows you to stay disconnected from the cold hard truth that when things really go wrong in your life, the only person who will be able to fix it and the only person will be responsible for it is you. If so…welcome to fake success. Passivity, dependence, and the sacrifice of practical thinking and personal responsibility to fuzzy, grandiose ideals and temporary feelings — these are markers of fake success. Intelligent Achievement, on the other hand, is not a moving target. It's not empty either. Instead, it's sturdy, full, and immovable. It's not something that's just handed to you. It's not something you're nudged to chase or coerced into wanting. Intelligent Achievement comes from within you. It's a collection of values that are aligned with who you are—values you have to protect and nurture. These values do not increase your dependence on other people and things. Instead, they relieve you of dependence. This kind of achievement is something that you have a part in building from the ground up—you know what's in it—you chose it, someone else didn't choose it for you. Achieving real success means you must focus, create, and grow daily. The Science of Intelligent Achievement will show you how.
Book Synopsis The Principal's Guide to Managing School Personnel by : Richard D. Sorenson
Download or read book The Principal's Guide to Managing School Personnel written by Richard D. Sorenson and published by Corwin Press. This book was released on 2008-11-10 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive guide to building successful relationships with all school personnel! Ideal for practicing and aspiring principals, this in-depth resource presents policies, procedures, and techniques for managing faculty and support staff and creating effective work environments. The authors provide case studies, strategies, and reflective exercises in each chapter to help administrators evaluate their schools and practices. Based on ISLLC and ELCC standards for school leadership, this book covers: Shaping school culture to promote shared ownership of the school’s vision Recruiting, selecting, and retaining qualified personnel Effective communication and conflict resolution Handling challenging situations such as supervising marginal employees and addressing grievances
Book Synopsis NIH Guide for Grants and Contracts by : National Institutes of Health (U.S.)
Download or read book NIH Guide for Grants and Contracts written by National Institutes of Health (U.S.) and published by . This book was released on 1981 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw
Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
