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Principles and practice of clinical research.

Author: John I Gallin; Frederick P Ognibene
Publisher: Oxford : Academic, 2012.
Edition/Format:   Print book : English : 3rd ed.View all editions and formats
Database:WorldCat
Summary:

Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. This title provides a fresh  Read more...

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: John I Gallin; Frederick P Ognibene
ISBN: 9780123821676 0123821673
OCLC Number: 809543018
Description: 1 volume ; 28 cm
Contents: *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

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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. ...an important resource for institutional Read more...

 
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