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Principles and Practice of Clinical Research

Author: John I Gallin; Frederick P Ognibene
Publisher: Amsterdam ; Boston ; Heidelberg [etc] : Elsevier, [2012?]
Edition/Format:   Computer file : EnglishView all editions and formats

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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Additional Physical Format: Principles and Practice of Clinical Research [Texte imprimé] / John I. Gallin
San Diego, CA, USA : Elsevier Science & Technology Books, 2012
Material Type: Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: John I Gallin; Frederick P Ognibene
ISBN: 9780123821676 0123821673
OCLC Number: 870993871
Notes: Titre provenant de la page de titre du document numérisé.
Numérisation de la 2e édition de San Diego (CA) : Elsevier Science & Technology Books, 2012.
Date de publication et éditeur d'après le site du fournisseur.
Description: 1 online resource.
Details: Navigateur Internet ; lecteur de fichier PDF.
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
Responsibility: edited by John I. Gallin, Frederick P. 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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