The CRC's Guide to Coordinating Clinical Research

The CRC's Guide to Coordinating Clinical Research PDF

Author: Karen E. Woodin

Publisher: CenterWatch

Published: 2004

Total Pages: 428

ISBN-13:

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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.

The CRC's Guide to Coordinating Clinical Research

The CRC's Guide to Coordinating Clinical Research PDF

Author: Karen E. Woodin

Publisher:

Published: 2011-06

Total Pages: 573

ISBN-13: 9781930624610

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New chapters, updated content, more tips, helpful exercises and more! The CRC's Guide to Coordinating Clinical Research has been one of the foremost training tools and reference guides for novice and experienced coordinators since the first edition was released in 2004. Now with new chapters on investigational product accountability, device and biologics trials and data safety monitoring boards, along with key takeaways and newly added case studies, The CRC's Guide is the most comprehensive resource available for on-site training staffs, professors or individuals interested in a step-by-step approach to coordinating successful clinical trials. Topics include: A comprehensive review of CRC roles and responsibilities Understanding regulations and GCPs Preparing for a study Working with study subjects The informed consent process Case report forms and EDC Study closure The future outlook Job descriptions and current academic programs Adverse Events and Safety Monitoring Sample Forms, Checklists and Logs Recommended for: Novice and experienced CRCs Health professionals interested in pursuing a career as a study coordinator Instructors conducting training and educational programs

Clinical Research Coordinator Manual

Clinical Research Coordinator Manual PDF

Author: Kane Williams

Publisher: Createspace Independent Publishing Platform

Published: 2017-05-15

Total Pages: 234

ISBN-13: 9781546939658

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This book is divided into 25 chapters covering more than 300 topics. This book will serve as a training guide to make your routine tasks more efficient, compliant and easy. After reading this book, Clinical Research Coordinators, clinical research personnel and aspirants would get: # Step by step in-depth training on roles and responsibilities of a clinical research coordinator before, during and after the completion of a clinical trial. # Discussion on day-to-day challenges and their solutions. # Training through real-time examples and ready-made checklists to conduct each activity more efficiently and correctly. # Guidance through strategies and measures to execute critical clinical trial activities. # Training on regulatory and ICH-GCP guidelines. # Tips on effective communication and coordination with site staff, investigator, sponsor, and IRB. # Assistance to become a better and successful clinical research coordinator. # Knowledge on other essential topics of clinical research.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research PDF

Author: John I. Gallin

Publisher: Elsevier

Published: 2011-04-28

Total Pages: 447

ISBN-13: 0080489567

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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 with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Bioethics Beyond the Headlines

Bioethics Beyond the Headlines PDF

Author: Albert R. Jonsen

Publisher: Rowman & Littlefield

Published: 2005

Total Pages: 218

ISBN-13: 9780742545243

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Bioethics asks fundamental questions. "Who lives? Who dies? Who decides?" These questions are relevant to us all. Too often, the general public's sole encounter with these weighty questions is through sound bites fed to us by the media--where complex, difficult matters are typically presented in superficial and inaccurate terms. Here, renowned bioethicist Albert R. Jonsen equips readers with the tools and background to navigate the fascinating and complex landscape of bioethics. Bioethics Beyond the Headlines is a primer. You will not find convoluted philosophical arguments in this volume. Rather, you will find an engaging sampling of the key questions in bioethics, including euthanasia, assisted reproduction, cloning and stem cells, neuroscience, access to healthcare, and even research on animals and questions of environmental ethics--areas typically overlooked in general introductions to bioethics. But a "primer" is not merely a first book--it should also "prime" the interest of the reader, to prepare the mind for a more expansive venture into these issues. Bioethics Beyond the Headlines intends to do just that.

Clinical Research Coordinator?s Manual

Clinical Research Coordinator?s Manual PDF

Author: Kane Williams

Publisher:

Published: 2017-05-15

Total Pages: 234

ISBN-13: 9781546916833

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This book is divided into 25 chapters covering more than 300 topics. This book will serve as a training guide to make your routine tasks more efficient, compliant and easy. After reading this book, Clinical Research Coordinators, clinical research personnel and aspirants would get:# Step by step in-depth training on roles and responsibilities of a clinical research coordinator before, during and after the completion of a clinical trial.# Discussion on day-to-day challenges and their solutions.# Training through real-time examples and ready-made checklists to conduct each activity more efficiently and correctly.# Guidance through strategies and measures to execute critical clinical trial activities.# Training on regulatory and ICH-GCP guidelines.# Tips on effective communication and coordination with site staff, investigator, sponsor, and IRB.# Assistance to become a better and successful clinical research coordinator. # Knowledge on other essential topics of clinical research.

The Craft of Research, 2nd edition

The Craft of Research, 2nd edition PDF

Author: Wayne C. Booth

Publisher: University of Chicago Press

Published: 2008-04-15

Total Pages: 348

ISBN-13: 0226065693

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Since 1995, more than 150,000 students and researchers have turned to The Craft of Research for clear and helpful guidance on how to conduct research and report it effectively . Now, master teachers Wayne C. Booth, Gregory G. Colomb, and Joseph M. Williams present a completely revised and updated version of their classic handbook. Like its predecessor, this new edition reflects the way researchers actually work: in a complex circuit of thinking, writing, revising, and rethinking. It shows how each part of this process influences the others and how a successful research report is an orchestrated conversation between a researcher and a reader. Along with many other topics, The Craft of Research explains how to build an argument that motivates readers to accept a claim; how to anticipate the reservations of thoughtful yet critical readers and to respond to them appropriately; and how to create introductions and conclusions that answer that most demanding question, "So what?" Celebrated by reviewers for its logic and clarity, this popular book retains its five-part structure. Part 1 provides an orientation to the research process and begins the discussion of what motivates researchers and their readers. Part 2 focuses on finding a topic, planning the project, and locating appropriate sources. This section is brought up to date with new information on the role of the Internet in research, including how to find and evaluate sources, avoid their misuse, and test their reliability. Part 3 explains the art of making an argument and supporting it. The authors have extensively revised this section to present the structure of an argument in clearer and more accessible terms than in the first edition. New distinctions are made among reasons, evidence, and reports of evidence. The concepts of qualifications and rebuttals are recast as acknowledgment and response. Part 4 covers drafting and revising, and offers new information on the visual representation of data. Part 5 concludes the book with an updated discussion of the ethics of research, as well as an expanded bibliography that includes many electronic sources. The new edition retains the accessibility, insights, and directness that have made The Craft of Research an indispensable guide for anyone doing research, from students in high school through advanced graduate study to businesspeople and government employees. The authors demonstrate convincingly that researching and reporting skills can be learned and used by all who undertake research projects. New to this edition: Extensive coverage of how to do research on the internet, including how to evaluate and test the reliability of sources New information on the visual representation of data Expanded bibliography with many electronic sources