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Principles and practice of clinical research

Author: John I Gallin; Frederick P Ognibene
Publisher: Oxford : Academic, ©2007.
Edition/Format:   Print book : English : 2nd edView all editions and formats

Describes the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. This book addresses the opportunities for translation of  Read more...


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Document Type: Book
All Authors / Contributors: John I Gallin; Frederick P Ognibene
ISBN: 9780123694409 012369440X
OCLC Number: 148277499
Notes: Previous edition: London: Academic, 2002.
Description: xvi, 430 pages : illustrations, portraits ; 28 cm
Contents: *A Historical Perspective on Clinical ResearchETHICAL, 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 MediaBIOSTATISTICS 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 LifeTECHNOLOGY 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
Responsibility: edited by John I. Gallin, Frederick Ognibene.


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PRAISE FOR THE FIRST EDITION:"...much needed and provides essentially all of the basic information required by investigators involved in clinical research. important resource for institutional Read more...

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