The Comprehensive Guide To Clinical Research

Author : Chris Sauber,Dan Sfera
Publisher : Independently Published
Page : 218 pages
File Size : 40,9 Mb
Release : 2019-04-21
Category : Electronic
ISBN : 1090349521

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The Comprehensive Guide To Clinical Research by Chris Sauber,Dan Sfera Pdf

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

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 49,8 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778

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A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf

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 : Karen E. Woodin,John C. Schneider
Publisher : CenterWatch
Page : 448 pages
File Size : 44,8 Mb
Release : 2003-01-01
Category : Medical
ISBN : 1930624379

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The CRA's Guide to Monitoring Clinical Research by Karen E. Woodin,John C. Schneider Pdf

Author : Lars Ole Bonde,Tony Wigram
Publisher : Jessica Kingsley Publishers
Page : 384 pages
File Size : 40,5 Mb
Release : 2002-07-05
Category : Psychology
ISBN : 9781846423499

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A Comprehensive Guide to Music Therapy by Lars Ole Bonde,Tony Wigram Pdf

Music therapists, as in medical and paramedical professions, 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 many components of such diversity, and is a thoroughly comprehensive guide to accessing and understanding the ideas, theory, research results and clinical outcomes that are the foundations of this field. Providing a detailed insight into the field of music therapy from an international perspective, this book enables the reader to see the complete picture of the multifaceted and fascinating world that is music therapy.

Author : Lawrence M. Friedman,Curt Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 384 pages
File Size : 45,9 Mb
Release : 1998
Category : Clinical trials
ISBN : 0387985867

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Fundamentals of Clinical Trials by Lawrence M. Friedman,Curt Furberg,David L. DeMets Pdf

This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Author : Karen E. Woodin
Publisher : CenterWatch
Page : 428 pages
File Size : 54,8 Mb
Release : 2004
Category : Clinical medicine
ISBN : UOM:39015060767186

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The CRC's Guide to Coordinating Clinical Research by Karen E. Woodin Pdf

This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.

Author : Natasha Martien,Jeff Nelligan
Publisher : Academic Press
Page : 278 pages
File Size : 54,5 Mb
Release : 2018-08-01
Category : Medical
ISBN : 9780128162439

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The Sourcebook for Clinical Research by Natasha Martien,Jeff Nelligan Pdf

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 : Allan Hackshaw
Publisher : John Wiley & Sons
Page : 224 pages
File Size : 49,6 Mb
Release : 2011-09-07
Category : Medical
ISBN : 9781444356663

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A Concise Guide to Clinical Trials by Allan Hackshaw Pdf

Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Author : Ali S. Faqi
Publisher : Elsevier
Page : 1074 pages
File Size : 49,7 Mb
Release : 2024-02-11
Category : Medical
ISBN : 9780323984621

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology

Author : Phyllis G. Supino,Jeffrey S. Borer
Publisher : Springer Science & Business Media
Page : 276 pages
File Size : 45,5 Mb
Release : 2012-06-22
Category : Medical
ISBN : 9781461433606

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Principles of Research Methodology by Phyllis G. Supino,Jeffrey S. Borer Pdf

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.

Author : Deborrah Norris
Publisher : Plexus Publishing (UK)
Page : 164 pages
File Size : 54,6 Mb
Release : 2004
Category : Clinical trials
ISBN : UOM:39015064104022

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Clinical Research Coordinator Handbook by Deborrah Norris Pdf

In this revised third edition of the essential reference for clinical research coordinators (CRCs), Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, a glossary, and more.

Author : Sherif Hanafy Mahmoud
Publisher : Springer
Page : 432 pages
File Size : 40,7 Mb
Release : 2019-03-28
Category : Medical
ISBN : 9783030117757

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Patient Assessment in Clinical Pharmacy by Sherif Hanafy Mahmoud Pdf

This comprehensive, first-of-its kind title is an indispensable resource for pharmacists looking to learn or improve crucial patient assessment skills relevant to all pharmacy practice settings. Pharmacists’ role as health care practitioners is evolving as they are taking a more active part in primary patient care -- helping patients manage their medications and diseases, providing patient education, and, in some jurisdictions, prescribing and adapting medications. To perform their day-to-day duties, pharmacists are best-served using a framework called the patient care process. This framework involves three steps: patient assessment; care plan development and implementation; and monitoring and follow up. Organized in four parts, this practical book begins with introductory chapters regarding the basics of patient assessment and the patient care process. Part II includes a detailed assessment of common symptoms encountered by pharmacists. Part III discusses assessment of patients with various chronic illnesses. Part IV addresses select specialized topics and assessment considerations. An invaluable contribution to the literature, Patient Assessment in Clinical Pharmacy: A Comprehensive Guide will be of great benefit to pharmacists, regardless of their practice setting, and to pharmacy students as well.

Author : Cemal Cingi,Nuray Bayar Muluk
Publisher : Springer
Page : 237 pages
File Size : 44,5 Mb
Release : 2016-11-15
Category : Medical
ISBN : 9783319443447

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Quick Guide to Good Clinical Practice by Cemal Cingi,Nuray Bayar Muluk Pdf

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 : Lynda H. Powell,Kenneth E. Freedland,Peter G. Kaufmann
Publisher : Springer Nature
Page : 324 pages
File Size : 43,8 Mb
Release : 2021-10-13
Category : Psychology
ISBN : 9783030393304

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Behavioral Clinical Trials for Chronic Diseases by Lynda H. Powell,Kenneth E. Freedland,Peter G. Kaufmann Pdf

This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Author : Ali S. Faqi
Publisher : Academic Press
Page : 904 pages
File Size : 45,9 Mb
Release : 2012-11-02
Category : Medical
ISBN : 9780123878151

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A Comprehensive Guide to Toxicology in Preclinical Drug Development by Ali S. Faqi Pdf

A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guidelines for safety evaluation and present both traditional and nontraditional toxicology models. By incorporating the latest research in this area and featuring real-life examples and scenarios, this reference is a complete and practical guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields. Includes the latest research in preclinical drug testing and international guidelines. Covers preclinical toxicology in small molecules and biologics in one single source. Incorporates real-life case studies and examples and offers readers a practical resource that outlines day-to-day activities and experiences in preclinical toxicology.