Author: Solar Biomedical
Publisher: iUniverse
ISBN: 166324992X
Category : Medical
Languages : en
Pages : 167
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Book Description
The purpose of this book is to provide novice and experienced clinical research professionals with a fun and effective way of learning and remembering the information found in ICH guidelines for Good Clinical Practice through word searches and flash cards. • Use the word search activities to help with word associations to help focus on and learn the different parts of the ICH Guidelines for Good Clinical Practice. The consolidated tripartite harmonized ICH- Good Clinical Practice [E6 (R2) – the Integrated Addendum to E6(R1)], General Considerations for Clinical Trials [E8 (R1)], and Clinical Safety Data Management (E2A), as published in the U.S. Federal Register May 9, 1997 and March 1, 1995 respectively, are attached to this book for your easy reference when solving the word search puzzles. • Use the flash cards as a tool for remembering specific GCP rules and CFR regulations in clinical research.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0
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Book Description
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Author: Margaret Liu
Publisher: John Wiley & Sons
ISBN: 1444357883
Category : Medical
Languages : en
Pages : 381
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Book Description
"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.
Author: Food and Drug Administration
Publisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
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Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author: Erving Goffman
Publisher: Anchor
ISBN: 0593468295
Category : Social Science
Languages : en
Pages : 335
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Book Description
A notable contribution to our understanding of ourselves. This book explores the realm of human behavior in social situations and the way that we appear to others. Dr. Goffman uses the metaphor of theatrical performance as a framework. Each person in everyday social intercourse presents himself and his activity to others, attempts to guide and cotnrol the impressions they form of him, and employs certain techniques in order to sustain his performance, just as an actor presents a character to an audience. The discussions of these social techniques offered here are based upon detailed research and observation of social customs in many regions.
Author: Louis R. Caplan
Publisher: Cambridge University Press
ISBN: 1107018862
Category : Medical
Languages : en
Pages : 633
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Book Description
A comprehensive survey of dysfunction due to stroke, this revised edition remains the definitive guide to stroke patterns and syndromes.
Author: Kathleen Desmaisons
Publisher: Simon and Schuster
ISBN: 1471105075
Category : Family & Relationships
Languages : en
Pages : 206
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Book Description
Have you ever wondered why you can't say no to fattening foods or alcohol? Why you overspend or overwork, feel bloated, have mood swings or depression? The answer is not that you're lazy, self-indulgent or undisciplined. The problem lies in your body chemistry. Millions of people are sugar sensitive and the foods they turn to for comfort actually trigger feelings of exhaustion, hopelessness and low self-esteem. In her groundbreaking book, Kathleen DesMaisons, Ph.D., explains how certain food-dependent chemicals in the brain regulate our moods. To maintain mental and physical health our serotonin, beta-endorphins and blood sugar levels need to be kept in balance. We can achieve this by following DesMaison's inexpensive, all-natural nutritional plan. There is no regime of measurements or self-denial: you tailor the plan to your tastes and lifestyle. More than just a book about food, this is a book about possibilities.
Author: Henry Mintzberg
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Synthesizes the empirical literature on organizationalstructuring to answer the question of how organizations structure themselves --how they resolve needed coordination and division of labor. Organizationalstructuring is defined as the sum total of the ways in which an organizationdivides and coordinates its labor into distinct tasks. Further analysis of theresearch literature is neededin order to builda conceptualframework that will fill in the significant gap left by not connecting adescription of structure to its context: how an organization actuallyfunctions. The results of the synthesis are five basic configurations (the SimpleStructure, the Machine Bureaucracy, the Professional Bureaucracy, theDivisionalized Form, and the Adhocracy) that serve as the fundamental elementsof structure in an organization. Five basic parts of the contemporaryorganization (the operating core, the strategic apex, the middle line, thetechnostructure, and the support staff), and five theories of how it functions(i.e., as a system characterized by formal authority, regulated flows, informalcommunication, work constellations, and ad hoc decision processes) aretheorized. Organizations function in complex and varying ways, due to differing flows -including flows of authority, work material, information, and decisionprocesses. These flows depend on the age, size, and environment of theorganization; additionally, technology plays a key role because of itsimportance in structuring the operating core. Finally, design parameters aredescribed - based on the above five basic parts and five theories - that areused as a means of coordination and division of labor in designingorganizational structures, in order to establish stable patterns of behavior.(CJC).
Author: Ishmael Beah
Publisher: Macmillan
ISBN: 0374105235
Category : Biography & Autobiography
Languages : en
Pages : 238
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Book Description
My new friends have begun to suspect I haven’t told them the full story of my life. “Why did you leave Sierra Leone?” “Because there is a war.” “You mean, you saw people running around with guns and shooting each other?” “Yes, all the time.” “Cool.” I smile a little. “You should tell us about it sometime.” “Yes, sometime.” This is how wars are fought now: by children, hopped-up on drugs and wielding AK-47s. Children have become soldiers of choice. In the more than fifty conflicts going on worldwide, it is estimated that there are some 300,000 child soldiers. Ishmael Beah used to be one of them. What is war like through the eyes of a child soldier? How does one become a killer? How does one stop? Child soldiers have been profiled by journalists, and novelists have struggled to imagine their lives. But until now, there has not been a first-person account from someone who came through this hell and survived. In A Long Way Gone, Beah, now twenty-five years old, tells a riveting story: how at the age of twelve, he fled attacking rebels and wandered a land rendered unrecognizable by violence. By thirteen, he’d been picked up by the government army, and Beah, at heart a gentle boy, found that he was capable of truly terrible acts. This is a rare and mesmerizing account, told with real literary force and heartbreaking honesty.
Author: World Health Organization
Publisher:
ISBN: 9789241593922
Category : Clinical medicine
Languages : en
Pages : 125
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Book Description
