The Sourcebook For Clinical Research

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The Sourcebook for Clinical Research

Author : Natasha Martien
Publisher : Academic Press
ISBN 13 : 0128162430
Total Pages : 278 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis The Sourcebook for Clinical Research by : Natasha Martien

Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-01 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

A Practical Guide to Managing Clinical Trials

Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.3/5 (152 download)

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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.

The Fundamentals of Clinical Research

Author : P. Michael Dubinsky
Publisher : John Wiley & Sons
ISBN 13 : 1118949595
Total Pages : 554 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis The Fundamentals of Clinical Research by : P. Michael Dubinsky

Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Principles and Practice of Clinical Research

Author : John I. Gallin
Publisher : Elsevier
ISBN 13 : 9780080489568
Total Pages : 448 pages
Book Rating : 4.4/5 (895 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Botanical Influences on Illness

Author : Melvyn R. Werbach
Publisher :
ISBN 13 :
Total Pages : 368 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Botanical Influences on Illness by : Melvyn R. Werbach

Download or read book Botanical Influences on Illness written by Melvyn R. Werbach and published by . This book was released on 1994 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consists of a series of chapters covering the major illnesses for which a reasonable amount of scientific literature exists on the medicinal application of botanicals. Individual plants and plant substances are discussed first, followed by any notable mixtures of two or more botanical ingredients.

The Comprehensive Guide To Clinical Research

Author : Chris Sauber
Publisher : Independently Published
ISBN 13 : 9781090349521
Total Pages : 218 pages
Book Rating : 4.3/5 (495 download)

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Book Synopsis The Comprehensive Guide To Clinical Research by : Chris Sauber

Download or read book The Comprehensive Guide To Clinical Research written by Chris Sauber and published by Independently Published. This book was released on 2019-04-21 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

A Clinical Trials Manual From The Duke Clinical Research Institute

Author : Margaret Liu
Publisher : John Wiley & Sons
ISBN 13 : 1444357883
Total Pages : 381 pages
Book Rating : 4.4/5 (443 download)

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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.

The CRA's Guide to Monitoring Clinical Research

Author : Karen E. Woodin
Publisher : CenterWatch
ISBN 13 : 9781930624375
Total Pages : 448 pages
Book Rating : 4.6/5 (243 download)

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Book Synopsis The CRA's Guide to Monitoring Clinical Research by : Karen E. Woodin

Download or read book The CRA's Guide to Monitoring Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2003-01-01 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Trials

Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Trials by : Tom Brody

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Essential Concepts in Clinical Research

Author : Kenneth Schulz
Publisher : Elsevier Health Sciences
ISBN 13 : 0702073938
Total Pages : 272 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Essential Concepts in Clinical Research by : Kenneth Schulz

Download or read book Essential Concepts in Clinical Research written by Kenneth Schulz and published by Elsevier Health Sciences. This book was released on 2018-07-19 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods. Written by leaders in the field of clinical research who have published extensively with authorship of hundreds of articles in medical journals. The authorship includes one of the three authors of the CONSORT guidelines for the reporting of randomized controlled trials. The book presents the essential concepts to a wide array of topics including randomized control trials, descriptive studies, cohort studies, case-control studies, bias, and screening tests. The book utilises a readable and humorous prose style, lightening what can be a difficult area for clinical readers. Derived from decades of teaching clinical research in seminar settings the book will empower clinicians to make sense of, and critically appraise, current medical research and will enable researchers to enrich the quality of their work. The updated new edition includes six new chapters: Surrogate endpoints Limitations of observational epidemiology Participant recruitment Practicalities of double-blinding Randomized trials in the context of a prospective meta-analysis Reporting studies in medical journals: CONSORT

Nutritional Influences on Illness

Author : Melvyn R. Werbach
Publisher : Keats Publishing
ISBN 13 : 9780879835316
Total Pages : 0 pages
Book Rating : 4.8/5 (353 download)

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Book Synopsis Nutritional Influences on Illness by : Melvyn R. Werbach

Download or read book Nutritional Influences on Illness written by Melvyn R. Werbach and published by Keats Publishing. This book was released on 1990 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to research and literature on the nutritional aspects of ninety-two diseases; discusses how nutrition affects and is affected by a variety of health conditions.

The Comprehensive Sourcebook of Bacterial Protein Toxins

Author : Joseph E. Alouf
Publisher : Elsevier
ISBN 13 : 0080456987
Total Pages : 1072 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis The Comprehensive Sourcebook of Bacterial Protein Toxins by : Joseph E. Alouf

Download or read book The Comprehensive Sourcebook of Bacterial Protein Toxins written by Joseph E. Alouf and published by Elsevier. This book was released on 2005-12-20 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the major achievements and discoveries relevant to bacterial protein toxins since the turn of the new century illustrated by the discovery of more than fifty novel toxins (many of them identified through genome screening). The establishment of the three-dimensional crystal structure of more than 20 toxins during the same period offers deeper knowledge of structure-activity relationships and provides a framework to understand how toxins recognize receptors, penetrate membranes and interact with and modify intracellular substrates. Edited by two of the most highly regarded experts in the field from the Institut Pasteur, France 14 brand new chapters dedicated to coverage of historical and general aspects of toxinology Includes the major toxins of both basic and clinical interest are described in depth Details applied aspects of toxins such as therapy, vaccinology, and toolkits in cell biology Evolutionary and functional aspects of bacterial toxins evaluated and summarized Toxin applications in cell biology presented Therapy (cancer therapy, dystonias) discussed Vaccines (native and genetically engineered vaccines) featured Toxins discussed as biological weapons, comprising chapters on anthrax, diphtheria, ricin etc.

The Chemotherapy Source Book

Author : Michael Clinton Perry
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 9780781773287
Total Pages : 820 pages
Book Rating : 4.7/5 (732 download)

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Book Synopsis The Chemotherapy Source Book by : Michael Clinton Perry

Download or read book The Chemotherapy Source Book written by Michael Clinton Perry and published by Lippincott Williams & Wilkins. This book was released on 2008 with total page 820 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Research Methodology in the Medical and Biological Sciences

Author : Petter Laake
Publisher : Academic Press
ISBN 13 : 9780080552897
Total Pages : 512 pages
Book Rating : 4.5/5 (528 download)

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Book Synopsis Research Methodology in the Medical and Biological Sciences by : Petter Laake

Download or read book Research Methodology in the Medical and Biological Sciences written by Petter Laake and published by Academic Press. This book was released on 2007-11-05 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing easy-to-access information, this unique sourcebook covers the wide range of topics that a researcher must be familiar with in order to become a successful experimental scientist. Perfect for aspiring as well as practicing professionals in the medical and biological sciences it discusses a broad range of topics that are common, yet not traditionally considered part of formal curricula. The information presented also facilitates communication across conventional disciplinary boundaries, in line with the increasingly multidisciplinary nature of modern research projects. Perfect for students with various professional backgrounds providing a broad scientific perspective Easily accessible, concise material makes learning about diverse methods achievable in today's fast-paced world

Practical Guide to Clinical Data Management

Author : Susanne Prokscha
Publisher : CRC Press
ISBN 13 : 1439848319
Total Pages : 296 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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,

Sourcebook of Models for Biomedical Research

Author : P. Michael Conn
Publisher : Springer Science & Business Media
ISBN 13 : 1597452858
Total Pages : 756 pages
Book Rating : 4.5/5 (974 download)

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Book Synopsis Sourcebook of Models for Biomedical Research by : P. Michael Conn

Download or read book Sourcebook of Models for Biomedical Research written by P. Michael Conn and published by Springer Science & Business Media. This book was released on 2008-03-07 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt: The collection of systems represented in this volume is a unique effort to reflect the diversity and utility of models used in biomedicine. That utility is based on the consideration that observations made in particular organisms will provide insight into the workings of other, more complex systems. This volume is therefore a comprehensive and extensive collection of these important medical parallels.

Sourcebook of Social Support and Personality

Author : Gregory R. Pierce
Publisher : Springer Science & Business Media
ISBN 13 : 9780306455353
Total Pages : 526 pages
Book Rating : 4.4/5 (553 download)

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Book Synopsis Sourcebook of Social Support and Personality by : Gregory R. Pierce

Download or read book Sourcebook of Social Support and Personality written by Gregory R. Pierce and published by Springer Science & Business Media. This book was released on 1997-07-31 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Sourcebook gives special attention to the complexity of the social support construct, expanding the field's theoretical base by reappraising social support research in the context of findings from other fields of psychology & related disciplines.