A Practical Guide to Managing Clinical Trials

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.

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  • Author : JoAnn Pfeiffer
  • Publisher : CRC Press
  • Pages : 256 pages
  • ISBN : 1315299771
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKA Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials
  • Author : JoAnn Pfeiffer,Cris Wells
  • Publisher : CRC Press
  • Release : 18 May 2017
GET THIS BOOKA Practical Guide to Managing Clinical Trials

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,

The Practical Guide to Clinical Research and Publication

The Practical Guide to Clinical Research and Publication
  • Author : Uzung Yoon
  • Publisher : Academic Press
  • Release : 03 August 2021
GET THIS BOOKThe Practical Guide to Clinical Research and Publication

The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It

Clinical Trials

Clinical Trials
  • Author : Duolao Wang,Ameet Bakhai
  • Publisher : Remedica
  • Release : 28 November 2021
GET THIS BOOKClinical Trials

This book aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
  • Author : Delva Shamley,Brenda Wright
  • Publisher : Academic Press
  • Release : 07 June 2017
GET THIS BOOKA Comprehensive and Practical Guide to Clinical Trials

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

The Comprehensive Guide To Clinical Research

The Comprehensive Guide To Clinical Research
  • Author : Chris Sauber,Dan Sfera
  • Publisher : Independently Published
  • Release : 21 April 2019
GET THIS BOOKThe Comprehensive Guide To Clinical Research

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

The Sourcebook for Clinical Research

The Sourcebook for Clinical Research
  • Author : Natasha Martien,Jeff Nelligan
  • Publisher : Academic Press
  • Release : 15 August 2018
GET THIS BOOKThe Sourcebook for Clinical Research

A clinical trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines, and specific protocol instructions to follow. The Sourcebook for Clinical Trials provides a comprehensive overview of the clinical trial process covering the basics to more advances topics. The book discusses foundational elements defining clinical trials and types of research studies, research personnel and responsibilities, and understanding the role of HIPAA and PHI. The book also covers pre-trial preparation and regulatory requirements, subject recruitment, mechanics and trial conduct,

Practical Guide to Clinical Data Management

Practical Guide to Clinical Data Management
  • Author : Susanne Prokscha
  • Publisher : CRC Press
  • Release : 26 October 2011
GET THIS BOOKPractical Guide to Clinical Data Management

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,

Clinical Trials and Human Research

Clinical Trials and Human Research
  • Author : Fay A. Rozovsky, JD, MPH,Rodney K. Adams
  • Publisher : Jossey-Bass
  • Release : 10 June 2003
GET THIS BOOKClinical Trials and Human Research

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

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
  • Author : John I. Gallin,Frederick P Ognibene
  • Publisher : Elsevier
  • Release : 28 April 2011
GET THIS BOOKPrinciples and Practice of Clinical Research

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply

Clinical Studies Management

Clinical Studies Management
  • Author : Simon Cook
  • Publisher : CRC Press
  • Release : 15 January 2004
GET THIS BOOKClinical Studies Management

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

Clinical Trials

Clinical Trials
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release : 19 February 2016
GET THIS BOOKClinical Trials

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual

Preventing and Treating Missing Data in Longitudinal Clinical Trials

Preventing and Treating Missing Data in Longitudinal Clinical Trials
  • Author : Craig H. Mallinckrodt
  • Publisher : Cambridge University Press
  • Release : 28 January 2013
GET THIS BOOKPreventing and Treating Missing Data in Longitudinal Clinical Trials

Recent decades have brought advances in statistical theory for missing data, which, combined with advances in computing ability, have allowed implementation of a wide array of analyses. In fact, so many methods are available that it can be difficult to ascertain when to use which method. This book focuses on the prevention and treatment of missing data in longitudinal clinical trials. Based on his extensive experience with missing data, the author offers advice on choosing analysis methods and on ways

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
  • Author : Allan Hackshaw
  • Publisher : John Wiley & Sons
  • Release : 07 September 2011
GET THIS BOOKA Concise Guide to Clinical Trials

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

Genome Editing

Genome Editing
  • Author : Kiran Musunuru
  • Publisher : Academic Press
  • Release : 05 March 2021
GET THIS BOOKGenome Editing

Genome Editing: A Practical Guide to Research and Clinical Applications is geared towards investigators interested in learning how to use CRISPR-Cas9-based technologies, with a focus on cardiovascular research and clinical applications. Covering a range of topics from the basics of genome editing to design considerations, to assessments and applications, this reference allows readers to get started and establish a full workflow from the beginning of the project to its full completion. With worked examples drawn from real-life experiments, as

A Practical Guide to Human Research and Clinical Trials

A Practical Guide to Human Research and Clinical Trials
  • Author : M. U. R. Naidu,P. Usha Rani
  • Publisher : CRC Press
  • Release : 29 January 2013
GET THIS BOOKA Practical Guide to Human Research and Clinical Trials

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