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Author: Marieke M. ter Wee
Publisher: Bohn Stafleu Van Loghum
ISBN: 9789036822473
Category : Medical
Languages : en
Pages :
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Book Description
This book is an essential guide on how to conduct human medical research with a focus on the fundamental concepts of contemporary biostatistics and epidemiology. It provides an overview of all necessary steps: from setting up research, analyzing collected data and publishing results as a scientific paper and also in finding the appropriate audience for a completed study. This comprehensive but compact book covers the writing of research proposals, choosing research designs, describing collected data, and understanding various techniques of inferential statistics. It is written from an applied point-of-view: two studies are used as example, which guide the reader through all steps, focusing on the interpretation of the results using SPSS (Statistical Package for the Social Sciences) output. A Quick Guide on How to Conduct Medical Research is not only an indispensable resource for PhD students, researchers as well as physicians performing their own research, but also for any readers of medical research who would like a deeper understanding of scientific publications. It can also be used in educational programs in the school of medicine, health sciences, human movement sciences, medical biology and paramedical schools.
Author: Marieke M. ter Wee
Publisher: Bohn Stafleu Van Loghum
ISBN: 9789036822473
Category : Medical
Languages : en
Pages :
Get Book Here
Book Description
This book is an essential guide on how to conduct human medical research with a focus on the fundamental concepts of contemporary biostatistics and epidemiology. It provides an overview of all necessary steps: from setting up research, analyzing collected data and publishing results as a scientific paper and also in finding the appropriate audience for a completed study. This comprehensive but compact book covers the writing of research proposals, choosing research designs, describing collected data, and understanding various techniques of inferential statistics. It is written from an applied point-of-view: two studies are used as example, which guide the reader through all steps, focusing on the interpretation of the results using SPSS (Statistical Package for the Social Sciences) output. A Quick Guide on How to Conduct Medical Research is not only an indispensable resource for PhD students, researchers as well as physicians performing their own research, but also for any readers of medical research who would like a deeper understanding of scientific publications. It can also be used in educational programs in the school of medicine, health sciences, human movement sciences, medical biology and paramedical schools.
Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Category : Mathematics
Languages : en
Pages : 292
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Book Description
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: Natasha Martien
Publisher: Academic Press
ISBN: 0128162430
Category : Medical
Languages : en
Pages : 278
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Book Description
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: Cemal Cingi
Publisher: Springer
ISBN: 3319443445
Category : Medical
Languages : en
Pages : 243
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Book Description
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 204
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Book Description
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Author: David Moher
Publisher: John Wiley & Sons
ISBN: 1118715616
Category : Medical
Languages : en
Pages : 411
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Book Description
Guidelines for Reporting Health Research is a practical guide to choosing and correctly applying the appropriate guidelines when reporting health research to ensure clear, transparent, and useful reports. This new title begins with an introduction to reporting guidelines and an overview of the importance of transparent reporting, the characteristics of good guidelines, and how to use reporting guidelines effectively in reporting health research. This hands-on manual also describes over a dozen internationally recognised published guidelines such as CONSORT, STROBE, PRISMA and STARD in a clear and easy to understand format. It aims to help researchers choose and use the correct guidelines for reporting their research, and to produce more completely and transparently reported papers which will help to ensure reports are more useful and are not misleading. Written by the authors of health research reporting guidelines, in association with the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, Guidelines for Reporting Health Research is a helpful guide to producing publishable research. It will be a valuable resource for researchers in their role as authors and also an important reference for editors and peer reviewers.
Author: David Ginsberg
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 324
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Book Description
The Investigator's Guide to Clinical Research is a step-by-step manual filled with tips, instructions and insights for investigators - novice and experienced - and health professionals involved in conducting clinical research. Along with updated sections, charts and statistics, the 3rd edition includes a detailed look at investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. A new appendix includes valuable lists of company contacts and additional resources. Developed in accordance with the essentials and standards of the ACCME. Exam is provided online. Topics include...An overview of the clinical development process; A review of regulatory requirements; How to set up and manage a research center; How to effectively and efficiently conduct clinical trials and How to identify and secure clinical grant opportunities.
Author: Sanjay Gupta
Publisher: Dna Press
ISBN: 8190827715
Category : Health & Fitness
Languages : en
Pages : 1
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Book Description
This book is intended to provide a comprehensive understanding of the essential clinical trial elements in a concise fashion. It is intended to serve as a quick reference guide to all the personnel involved in the conduct of clinical trials as well as to those who plan to enter this field. Spanning over 167 pages the book provides a thorough compilation on, 1. Fundamentals of Clinical Research 2. Glossary of Clinical Trials Terminology (1052 frequently used terminologies of clinical research) 3. Abbreviations (224 frequently used terminologies of clinical research) 4. Clinical Trial Stakeholders 5. Clinical Study Process 6. Location of Essential Documents Before, During and After Completion of a Clinical Trial 7. Critical Milestones of a Clinical Trial Project 8. Overview of Regulatory Environment in USA, Australia, Europe, UK and India Being the first and only book on this important topic it has fulfilled the unmet need and is of great benefit to all the personnel involved in clinical research.
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: Kathryn H. Jacobsen
Publisher: Jones & Bartlett Publishers
ISBN: 1284094383
Category : Medical
Languages : en
Pages : 393
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Book Description
A step-by-step guide to conducting research in medicine, public health, and other health sciences, this clear, practical, and straightforward text demystifies the research process and empowers students (and other new investigators) to conduct their own original research projects.