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Lessons From a Horse Named Jim by Kate Davis,Margaret B. Liu Pdf
Written by members of the Duke Clinical Research Institute (DCRI) who develop instructional materials for on-site clinical trialists, this exciting, well-produced, practical book bridges the gap between the theory of clinical trial design, along with the statistical and clinical interpretations of data, and the process of conducting clinical trials. The authors have pulled together information relating to the pragmatic conduct of clinical trials and organized all of it into a single, invaluable volume.
Author : Margaret Liu,Kate Davis Publisher : John Wiley & Sons Page : 381 pages File Size : 42,8 Mb Release : 2011-08-24 Category : Medical ISBN : 9781444357882
A Clinical Trials Manual From The Duke Clinical Research Institute by Margaret Liu,Kate Davis Pdf
"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.
A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf
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.
Practical Guide to Clinical Data Management by Susanne Prokscha Pdf
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then,
NEW YORK TIMES BESTSELLER • For the first time ever—a comprehensive biography of one of the twentieth century’s most innovative creative artists: the incomparable, irreplaceable Jim Henson He was a gentle dreamer whose genial bearded visage was recognized around the world, but most people got to know him only through the iconic characters born of his fertile imagination: Kermit the Frog, Bert and Ernie, Miss Piggy, Big Bird. The Muppets made Jim Henson a household name, but they were just part of his remarkable story. This extraordinary biography—written with the generous cooperation of the Henson family—covers the full arc of Henson’s all-too-brief life: from his childhood in Leland, Mississippi, through the years of burgeoning fame in America, to the decade of international celebrity that preceded his untimely death at age fifty-three. Drawing on hundreds of hours of new interviews with Henson's family, friends, and closest collaborators, as well as unprecedented access to private family and company archives, Brian Jay Jones explores the creation of the Muppets, Henson’s contributions to Sesame Street and Saturday Night Live, and his nearly ten-year campaign to bring The Muppet Show to television. Jones provides the imaginative context for Henson’s non-Muppet projects, including the richly imagined worlds of The Dark Crystal and Labyrinth—as well as fascinating misfires like Henson’s dream of opening an inflatable psychedelic nightclub. An uncommonly intimate portrait, Jim Henson captures all the facets of this American original: the master craftsman who revolutionized the presentation of puppets on television, the savvy businessman whose dealmaking prowess won him a reputation as “the new Walt Disney,” and the creative team leader whose collaborative ethos earned him the undying loyalty of everyone who worked for him. Here also is insight into Henson’s intensely private personal life: his Christian Science upbringing, his love of fast cars and expensive art, and his weakness for women. Though an optimist by nature, Henson was haunted by the notion that he would not have time to do all the things he wanted to do in life—a fear that his heartbreaking final hours would prove all too well founded. An up-close look at the charmed life of a legend, Jim Henson gives the full measure to a man whose joyful genius transcended age, language, geography, and culture—and continues to beguile audiences worldwide. NAMED ONE OF THE BEST BOOKS OF THE YEAR BY BOOKPAGE “Jim Henson vibrantly delves into the magnificent man and his Muppet methods: It’s an absolute must-read!”—Neil Patrick Harris “An exhaustive work that is never exhausting, a credit both to Jones’s brisk style and to Henson’s exceptional life.”—The New York Times “[A] sweeping portrait that is a mix of humor, mirth and poignancy.”—Washington Independent Review of Books “A meticulously researched tome chock-full of gems about the Muppets and the most thorough portrait of their creator ever crafted.”—Associated Press
The Experiment Must Continue by Melissa Graboyes Pdf
The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight failed attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society.
Clinical Trials Audit Preparation by Vera Mihajlovic-Madzarevic Pdf
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions. Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English. This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.
The Essential Guide to N-of-1 Trials in Health by Jane Nikles,Geoffrey Mitchell Pdf
N-of-1 trials, a type of individualized randomized controlled trial, are relevant to almost every discipline in medicine and psychology. They can tell the clinician with precision whether a treatment works in that individual, which distinguishes from the information available from most other trial designs. They have the potential to revolutionize the way clinical medicine is practiced. Whether you are a busy clinician, a researcher or a student, this book provides everything you need to know about N-of-1 trials. Written and edited by some of the world’s leading experts on N-of-1 trials, the book presents state of the art knowledge about N-of-1 trials, with chapters on ethics, statistics, health economics, design, analysis and reporting, and more. Full of examples and well illustrated, it is a comprehensive compendium of issues surrounding the design, conduct, interpretation and implementation of N-of-1 trials in a health system.
This book is a must-read guide for those entering the world of HealthTech startups. Author David Putrino, a veteran in the world of HealthTech and Telemedicine, details the roles, necessity, and values of key members of a typical HealthTech team, and helps readers understand the motivations and core priorities of all people involved. In ventures that typically depend upon effective communication between members from business, science, regulatory, and academic backgrounds, this book helps develop the core competencies that team members need to work harmoniously. Four detailed case studies are shared that exemplify the spectrum of HealthTech possibilities, including large corporations, tiny startups, elite athletes, and social good enterprises. Each case study shows how the success or failure of a project can hinge upon strong team dynamics, a deep understanding of the target population's needs and a strong awareness of each team member’s long-term goals. This book is essential reading for entrepreneurs, scientists, clinicians, marketing and sales professionals, and all those looking to create new and previously unimagined possibilities for improving the lives of people everywhere.
The Sourcebook for Clinical Research by Natasha Martien,Jeff Nelligan Pdf
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
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
Institute of Medicine,Roundtable on Evidence-Based Medicine
Author : Institute of Medicine,Roundtable on Evidence-Based Medicine Publisher : National Academies Press Page : 374 pages File Size : 40,6 Mb Release : 2007-06-01 Category : Medical ISBN : 9780309133937
The Learning Healthcare System by Institute of Medicine,Roundtable on Evidence-Based Medicine Pdf
As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.
