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Principles and Practice of Clinical Research

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ISBN-10: 0123821673

ISBN-13: 9780123821676

Edition: 3rd 2012

Authors: John I. Gallin, Frederick P. Ognibene

List price: $97.99
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Description:

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…    
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Book details

List price: $97.99
Edition: 3rd
Copyright year: 2012
Publisher: Elsevier Science & Technology
Publication date: 7/10/2012
Binding: Hardcover
Pages: 796
Size: 8.46" wide x 10.87" long x 1.75" tall
Weight: 5.192

A Historical Perspective on Clinical Research
ETHICAL, REGULATORY, AND LEGAL ISSUES
Ethical Principles in Clinical Research
Researching a Bioethical Question
Integrity in Research: Individual and Institutional Responsibility
Institutional Review Boards
Data and Safety Monitoring Boards
Data Management in Clinical Trials
Unanticipated Risks in Clinical Research
The Regulation of Drugs and Biological Products by the Food and Drug Administration
Legal Issues
Rules to Prevent Conflict of Interest for Clinical Investigators Conducting Human Subjects Research
National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
Clinical Research: A Patient Perspective
The Clinical Researcher and the Media
BIOSTATISTICS AND EPIDEMIOLOGY
An Introduction to Biostatistics: Randomization, Hypothesis Testing, and Sample Size Estimation
Design and Conduct of Observational Studies and Clinical Trials
Small Clinical Trials
Large Clinical Trials and Registries - Clinical Research Institutes
Using Secondary Data in Statistical Analysis
An Introduction to Survival Analysis
Measures of Function and Health-Related Quality of Life
TECHNOLOGY TRANSFER, PROTOCOL DEVELOPMENT, FUNDING AND OTHER ISSUES
Overview of Technology Development
Technology Transfer
Writing a Protocol
Evaluating a Protocol Budget
Data Management in Clinical Research: General Principles and a Guide to Sources
Getting the Funding You Need to Support Your Research: Navigating the National Institutes of Health Peer Review Process
Clinical Research from the Industry Perspective
Human Genome Project, Genomics, and Clinical Research