The Comprehensive Guide To Clinical Research
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The Comprehensive Guide To Clinical Research
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Author : Chris Sauber
language : en
Publisher: Independently Published
Release Date : 2019-04-21
The Comprehensive Guide To Clinical Research written by Chris Sauber and has been published by Independently Published this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-21 with categories.
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
Clinical Trials
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Author : Duolao Wang
language : en
Publisher: Remedica
Release Date : 2006
Clinical Trials written by Duolao Wang and has been published by Remedica this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.
This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Principles Of Research Methodology
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Author : Phyllis G. Supino
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-06-22
Principles Of Research Methodology written by Phyllis G. Supino and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-22 with Medical categories.
Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.
Clinical Trials And Human Research
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Author : Fay A. Rozovsky
language : en
Publisher: Jossey-Bass
Release Date : 2003-06-10
Clinical Trials And Human Research written by Fay A. Rozovsky and has been published by Jossey-Bass this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-06-10 with Medical categories.
This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
Clinical Trials Audit Preparation
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Author : Vera Mihajlovic-Madzarevic
language : en
Publisher: John Wiley & Sons
Release Date : 2010-09-29
Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-29 with Medical categories.
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
The Sourcebook For Clinical Research
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Author : Natasha Martien
language : en
Publisher: Academic Press
Release Date : 2018-08-01
The Sourcebook For Clinical Research written by Natasha Martien and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-01 with Medical categories.
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 Comprehensive Guide To Music Therapy
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Author : Tony Wigram
language : en
Publisher: Jessica Kingsley Publishers
Release Date : 2002
A Comprehensive Guide To Music Therapy written by Tony Wigram and has been published by Jessica Kingsley Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Psychology categories.
Music therapists have a rich diversity of approaches and methods, often developed with specific relevance to meet the needs of a certain client population. This book reflects the components of such diversity, and is a comprehensive guide to accessing the ideas, theory, research results and clinical outcomes that are the foundations of this field.
Clinical Art Therapy
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Author : Helen B. Landgarten
language : en
Publisher: Taylor & Francis
Release Date : 1981
Clinical Art Therapy written by Helen B. Landgarten and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 1981 with Family & Relationships categories.
First Published in 1987. Routledge is an imprint of Taylor & Francis, an informa company.
Clinical Research Made Easy
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Author : Mohit Bhandari
language : en
Publisher: Jaypee Brothers Medical Publishers Pvt. Limited
Release Date : 2010-02-28
Clinical Research Made Easy written by Mohit Bhandari and has been published by Jaypee Brothers Medical Publishers Pvt. Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-02-28 with Medical categories.