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
Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2007 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third edition sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology and offers an updated syllabus for conducting a clinical research workshop.
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.
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2002-01-24 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research. Key Features * Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology * Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display * Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH * Excellent companion text for courses on clinical research
Download or read book Klinische Forschung written by Winfried Koch and published by Springer-Verlag. This book was released on 2013-03-07 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: Klinische Forschung hat als Forschung am kranken Menschen besonders hohen ethischen Anforderungen zu genügen. Neue Therapieformen dürfen niemals ohne sorgfältige Erfolgskontrolle eingesetzt werden. Ethische Normen, wie die "Deklaration von Helsinki" und die Arzneimittelgesetze der einzelnen Länder, legen unter anderem fest, daß ein Prüfplan ausgearbeitet werden muß. Dieses Buch hilft bei der Erstellung eines solchen Prüfplans. Es beschreibt nicht nur, welche Punkte in einem Prüfplan enthalten sein müssen, sondern gibt zahlreiche Hinweise, wie ein solches Forschungsprogramm zur Sicherheit der Patienten produktiv der Fragestellung angepaßt werden kann.
Download or read book Das KliFo Buch written by Michael Herschel and published by Georg Thieme Verlag. This book was released on 2018-02-21 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: Klinische Forschung mit Erfolg Projektmanagement, juristische und regulatorische Aspekte, konkrete Durchführung von Studien – in diesem Praxisbuch finden Sie alles, was Sie über klinische Forschung wissen müssen! Von der Idee bis zur abschließenden Analyse und Veröffentlichung werden sämtliche Schritte klinischer Studien mit fundiertem Know-how und vielen praktischen Anleitungen, aber ohne komplizierte Mathematik erklärt. Ein Fokus liegt auf häufig auftretenden Problemen und zeigt Ihnen Wege auf, diese zu lösen. Die 3., vollständig aktualisierte Auflage berücksichtigt die 16. AMG-Novelle einschließlich der Änderungsgesetze und der daraus resultierenden Veränderungen hinsichtlich der neuen EU-Verordnung. Auch PASS- und PAES-Studien sowie das Thema risikoadaptiertes Monitoring sind hinzugekommen. Für Ärzte und Naturwissenschaftler, die in Kliniken, Praxen, pharmazeutischen Unternehmen und Auftragsforschungsinstituten tätig sind, ist Das KliFo-Buch der ideale Kompass bei der Realisierung von interventionellen wie nichtinterventionellen Studien sowie bei der Entwicklung von Diagnostika und diagnostischen Verfahren.
Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2013-05-08 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.
Download or read book Foundations of Clinical Research written by Leslie G Portney and published by F.A. Davis. This book was released on 2020-01-16 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Become a successful evidence-based practitioner. How do you evaluate the evidence? Is the information accurate, relevant and meaningful for clinical decision making? Did the design fit the research questions and was the analysis and interpretation of data appropriate? Here are all the materials you need to take your first steps as evidence-based practitioners…how to use the design, data and analysis of research as the foundation for effective clinical decision making. You’ll find support every step of the way as you progress from the foundations of clinical research and concepts of measurement through the processes of designing studies and analyzing data to writing their own research proposal.
Download or read book Die klinische Pr fung in der Medizin Clinical Trials in Medicine written by Erwin Deutsch and published by Springer-Verlag. This book was released on 2006-03-30 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Auf dem Prüfstand: die Richtlinie 2001/20/EG des Rates zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen in der Humanmedizin und bei Humanarzneimitteln. Vor dem Hintergrund der anstehenden Umsetzung geht das Buch der Frage nach, auf welche neueren Entwicklungen die Richtlinie im europäischen Recht trifft. 14 Landesberichte liefern wichtige Informationen über den Stand der Diskussion.
Download or read book Foundations of Clinical Research written by Leslie Gross Portney and published by . This book was released on 2000 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a comprehensive reference for a variety of research situations. This edition reflects the popular approaches to analysis and design, and addresses the focus of health-care related research through the 1990s and into the 21st century. Expanded or added topics include outcomes research and the disablement model, validity and diagnostic screening, meta-analysis, scales used in survey and outcomes research, logistic regression, measures of reliability, and data management to prepare for computer analysis. For those in the health professions, including physical therapy, occupational therapy, speech therapy, nursing, and exercise physiology.
Download or read book Das KliFo Buch written by Michael Herschel and published by Georg Thieme Verlag. This book was released on 2013-01-23 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: Von der Idee bis zur Veröffentlichung – klinische Forschung mit Erfolg! Intelligentes Projektmanagement ist das wichtigste Werkzeug für effiziente klinische Forschung. Dabei sind umfassende Kenntnisse der theoretischen Grundlagen genauso wie medizinisches Fachwissen VorausSetzung für den Erfolg: Zu groß ist sonst die Gefahr, an regulatorischen Hürden oder praktischen Problemen zu scheitern. Auf Basis seiner langjährigen Erfahrung in der klinischen Forschung verbindet Michael Herschel auch in dieser vollständig aktualisierten und überarbeiteten 2. Auflage theoretisches Know-how mit vielen praktischen Anleitungen. Für Ärzte, Naturwissenschaftler und Entscheidungsträger, die in Kliniken, Praxen, pharmazeutischen Unternehmen und Auftragsforschungsinstituten im Bereich der klinischen Forschung tätig sind, ist das Buch der ideale Kompass bei der Realisierung von interventionellen wie nicht-interventionellen Studien sowie bei der Entwicklung von Diagnostika und diagnostischen Verfahren.
Download or read book Wie liest und bewertet man eine klinische Studie written by Konrad Wink and published by Georg Thieme Verlag. This book was released on 2006-08-01 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: Klinische Studien nehmen bei der Anwendung diagnostischer und therapeutischer Maßnahmen einen hohen Stellenwert ein: Da anhand ihrer Ergebnisse Wirksamkeitsbeweise mit hoher Wahrscheinlichkeit geführt werden können, beruhen insbesondere Therapieempfehlungen auf diesem Evidenz-basierten Verfahren. Um diese Empfehlungen nachvollziehen und für die eigenen Patienten kritisch überprüfen zu können, ist es unabdingbar, dass die Originalarbeiten und deren Aussagekraft eigenständig und fundiert bewertet werden können. Diese bewusst kurz gefasste Anleitung zur Studienanalyse gibt hierfür die geeigneten Instrumente an die Hand. Kurz und prägnant werden die einzelnen Kriterien, die für die Qualität einer Studie maßgebend sind, beschrieben und im Hinblick auf die praktische Anwendung erläutert. Die verständliche Definition wesentlicher biometrischer Größen gestattet eine sichere Beurteilung der jeweiligen statistischen Auswertung. Eine „Checkliste" im Anhang zeigt Schritt für Schritt, wie die jeweils vorliegenden Kriterien herausgearbeitet und geprüft werden können. So wird es auch Ungeübten möglich, den schwierigen Weg durch den Daten-Dschungel einer klinischen Studie zu finden und deren Ergebnisse richtig zu interpretieren und zu bewerten. Somit befähigt der Leitfaden praktisch und wissenschaftlich tätige Ärzte, Medizinstudenten, Pharmazeuten und Naturwissenschaftler dazu, die Ergebnisse wissenschaftlicher Studien entsprechend ihrer klinischen Relevanz zum Wohl der Patienten anzuwenden.
Download or read book Publishing and Presenting Clinical Research written by Warren S. Browner and published by Lippincott Williams & Wilkins. This book was released on 2012-03-19 with total page 227 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publishing and Presenting Clinical Research, Fourth Edition is an excellent primer for investigators who wish to learn how to organize, present, and publish results of their research. Written by an experienced clinical researcher and editor, it uses hundreds of examples, tables and figures to show how to produce successful abstracts, posters, oral presentations, and manuscripts for publication. This book also serves as a companion to the popular text, Designing Clinical Research. This edition contains the latest: • Guidance on getting work accepted in medical journals and at scientific meetings • Examples of the do’s and don’ts of data presentation • Explanations of confusing statistical terminology • Templates to get started and avoid writers’ block • Tips for creating simple graphics and tables • Help for those who are not fluent in English • Suggestions about getting the most from a poster session • Checklists for each section of a manuscript or presentation • Advice about authorship and responding to reviewers’ comments Plus with this edition, there is access to a companion website with fully searchable text so you can access the content anytime, anywhere.
Download or read book Sample Sizes for Clinical Laboratory and Epidemiology Studies written by David Machin and published by John Wiley & Sons. This book was released on 2018-05-29 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authoritative resource that offers the statistical tools and software needed to design and plan valid clinical studies Now in its fourth and extended edition, Sample Sizes for Clinical, Laboratory and Epidemiology Studiesincludes the sample size software (SSS) and formulae and numerical tables needed to design valid clinical studies. The text covers clinical as well as laboratory and epidemiology studies and contains the information needed to ensure a study will form a valid contribution to medical research. The authors, noted experts in the field, explain step by step and explore the wide range of considerations necessary to assist investigational teams when deriving an appropriate sample size for their when planned study. The book contains sets of sample size tables with companion explanations and clear worked out examples based on real data. In addition, the text offers bibliography and references sections that are designed to be helpful with guidance on the principles discussed. This revised fourth edition: Offers the only text available to include sample size software for use in designing and planning clinical studies Presents new and extended chapters with many additional and refreshed examples Includes clear explanations of the principles and methodologies involved with relevant practical examples Makes clear a complex but vital topic that is designed to ensure valid methodology and publishable results Contains guidance from an internationally recognised team of medical statistics experts Written for medical researchers from all specialities and medical statisticians, Sample Sizes for Clinical, Laboratory and EpidemiologyStudies offers an updated fourth edition of the important guide for designing and planning reliable and evidence based clinical studies.
Download or read book Foundations of Clinical Research written by and published by . This book was released on 2002-01-01 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trials written by Lorna Speid, Ph.D and published by Oxford University Press. This book was released on 2010-07-30 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.
