A Practical Guide To Managing Clinical Trials

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A Practical Guide to Managing Clinical Trials

JoAnn Pfeiffer,Cris Wells

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 49,9 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.

A Comprehensive and Practical Guide to Clinical Trials

Delva Shamley,Brenda Wright

Author : Delva Shamley,Brenda Wright
Publisher : Academic Press
Page : 210 pages
File Size : 43,6 Mb
Release : 2017-06-07
Category : Medical
ISBN : 9780128047309

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A Comprehensive and Practical Guide to Clinical Trials by Delva Shamley,Brenda Wright Pdf

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Practical Guide to Clinical Data Management

Susanne Prokscha

Author : Susanne Prokscha
Publisher : CRC Press
Page : 296 pages
File Size : 43,9 Mb
Release : 2011-10-26
Category : Computers
ISBN : 9781439848319

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Practical Guide to Clinical Data Management by Susanne Prokscha Pdf

Clinical Studies Management

Simon Cook

Author : Simon Cook
Publisher : CRC Press
Page : 128 pages
File Size : 55,8 Mb
Release : 2004-01-15
Category : Medical
ISBN : 0849320844

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Clinical Studies Management by Simon Cook Pdf

What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference and guide, Clinical Studies Management: A Practical Guide to Success provides the practical skills and methods required by project managers running clinical studies. The author explains a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He solidly reviews how modern management theory can be brought to bear on the specialized demands of clinical trials. The book covers the practical how-tos of writing and costing a study, organizing an Investigator Meeting, and improving patient enrollment in your study. Divided into stand-alone chapters that make the information easy to find, the book presents a comprehensive overview of drug development processes and the trends that are driving change. If you are new to study management, the book rapidly brings you up to speed. If you are an experienced study manager, it gives you a convenient and authoritative reference you will use on a daily basis. Whatever your level of experience, Clinical Studies Management: A Practical Guide to Success supplies the tools you need to manage your projects efficiently and effectively.

Clinical Trials

Duolao Wang,Ameet Bakhai

Author : Duolao Wang,Ameet Bakhai
Publisher : Remedica
Page : 497 pages
File Size : 52,5 Mb
Release : 2006
Category : Medical
ISBN : 9781901346725

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Clinical Trials by Duolao Wang,Ameet Bakhai Pdf

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.

Medical Data Management

Florian Leiner,Wilhelm Gaus,Reinhold Haux,Petra Knaup-Gregori

Author : Florian Leiner,Wilhelm Gaus,Reinhold Haux,Petra Knaup-Gregori
Publisher : Springer Science & Business Media
Page : 230 pages
File Size : 41,7 Mb
Release : 2003-01-14
Category : Computers
ISBN : 0387951598

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Medical Data Management by Florian Leiner,Wilhelm Gaus,Reinhold Haux,Petra Knaup-Gregori Pdf

Medical Data Management is a systematic introduction to the basic methodology of professional clinical data management. It emphasizes generic methods of medical documentation applicable to such diverse tasks as the electronic patient record, maintaining a clinical trials database, and building a tumor registry. This book is for all students in medical informatics and health information management, and it is ideal for both the undergraduate and the graduate levels. The book also guides professionals in the design and use of clinical information systems in various health care settings. It is an invaluable resource for all health care professionals involved in designing, assessing, adapting, or using clinical data management systems in hospitals, outpatient clinics, study centers, health plans, etc. The book combines a consistent theoretical foundation of medical documentation methods outlining their practical applicability in real clinical data management systems. Two new chapters detail hospital information systems and clinical trials. There is a focus on the international classification of diseases (ICD-9 and -10) systems, as well as a discussion on the difference between the two codes. All chapters feature exercises, bullet points, and a summary to provide the reader with essential points to remember. New to the Third Edition is a comprehensive section comprised of a combined Thesaurus and Glossary which aims to clarify the unclear and sometimes inconsistent terminology surrounding the topic.

A Practical Guide to Cluster Randomised Trials in Health Services Research

Sandra Eldridge,Sally Kerry

Author : Sandra Eldridge,Sally Kerry
Publisher : John Wiley & Sons
Page : 299 pages
File Size : 47,7 Mb
Release : 2012-02-20
Category : Medical
ISBN : 9780470510476

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A Practical Guide to Cluster Randomised Trials in Health Services Research by Sandra Eldridge,Sally Kerry Pdf

Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.

A Practical Guide to Quality Management in Clinical Trial Research

Graham Ogg

Author : Graham Ogg
Publisher : CRC Press
Page : 0 pages
File Size : 54,9 Mb
Release : 2005-11-01
Category : Medical
ISBN : 0849397227

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A Practical Guide to Quality Management in Clinical Trial Research by Graham Ogg Pdf

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

Practical Guide to Clinical Data Management, Third Edition

Susanne Prokscha

Author : Susanne Prokscha
Publisher : CRC Press
Page : 298 pages
File Size : 46,8 Mb
Release : 2011-10-26
Category : Computers
ISBN : 9781439848296

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Practical Guide to Clinical Data Management, Third Edition by Susanne Prokscha Pdf

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, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

Clinical Trials and Human Research

Fay A. Rozovsky,Rodney K. Adams

Author : Fay A. Rozovsky,Rodney K. Adams
Publisher : Jossey-Bass
Page : 0 pages
File Size : 42,5 Mb
Release : 2003-06-10
Category : Medical
ISBN : 0787965707

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Clinical Trials and Human Research by Fay A. Rozovsky,Rodney K. Adams Pdf

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.

A Practical Guide to Human Research and Clinical Trials

M. U. R. Naidu,P. Usha Rani

Author : M. U. R. Naidu,P. Usha Rani
Publisher : CRC Press
Page : 350 pages
File Size : 52,9 Mb
Release : 2013-01-29
Category : Medical
ISBN : 146659117X

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A Practical Guide to Human Research and Clinical Trials by M. U. R. Naidu,P. Usha Rani Pdf

Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.

Designing Clinical Research

Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman

Author : Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Publisher : Lippincott Williams & Wilkins
Page : 388 pages
File Size : 42,6 Mb
Release : 2011-11-30
Category : Medical
ISBN : 9781451165852

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Designing Clinical Research by Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman Pdf

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 edition 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. All chapters have been thoroughly revised, updated, and made more user-friendly.

Clinical Trials

Stuart J. Pocock

Author : Stuart J. Pocock
Publisher : John Wiley & Sons
Page : 288 pages
File Size : 52,8 Mb
Release : 2013-07-17
Category : Medical
ISBN : 9781118794104

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Clinical Trials by Stuart J. Pocock Pdf

This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Clinical Practice Guidelines We Can Trust

Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Publisher : National Academies Press
Page : 217 pages
File Size : 46,5 Mb
Release : 2011-06-16
Category : Medical
ISBN : 9780309216463

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Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

The Sourcebook for Clinical Research

Natasha Martien,Jeff Nelligan

Author : Natasha Martien,Jeff Nelligan
Publisher : Academic Press
Page : 278 pages
File Size : 54,7 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

A Practical Guide To Managing Clinical Trials

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

A Comprehensive and Practical Guide to Clinical Trials by Delva Shamley,Brenda Wright Pdf

Practical Guide to Clinical Data Management by Susanne Prokscha Pdf

Clinical Studies Management by Simon Cook Pdf

Clinical Trials by Duolao Wang,Ameet Bakhai Pdf

Medical Data Management by Florian Leiner,Wilhelm Gaus,Reinhold Haux,Petra Knaup-Gregori Pdf

A Practical Guide to Cluster Randomised Trials in Health Services Research by Sandra Eldridge,Sally Kerry Pdf

A Practical Guide to Quality Management in Clinical Trial Research by Graham Ogg Pdf

Practical Guide to Clinical Data Management, Third Edition by Susanne Prokscha Pdf

Clinical Trials and Human Research by Fay A. Rozovsky,Rodney K. Adams Pdf

A Practical Guide to Human Research and Clinical Trials by M. U. R. Naidu,P. Usha Rani Pdf

Designing Clinical Research by Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman Pdf

Clinical Trials by Stuart J. Pocock Pdf

Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf

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

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