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Principles and practice of clinical research

Author: John I Gallin
Publisher: San Diego, CA : Academic Press, 2002.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Database:WorldCat
Summary:
Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Principles and practice of clinical research
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: John I Gallin
ISBN: 0122740653 9780122740657
OCLC Number: 730025489
Description: 1 online resource (Online-Datei.)
Contents: Preface. --
Acknowledgements. --
Historical Perspective and Introduction. --
Part I: 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 and Data Management in Clinical Trials. --
Unanticipated Risk in Clinical Research. --
The Regulation of Drugs and Biological Products by the Food and Drug Administration. --
Legal Issues. --
NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. --
Part II: Biostatistics and Epidemiology --
An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size. --
Design and Conduct of Observational Studies and Clinical Trials. --
Small Clinical Trials. --
Large Clinical Trials Clinical Research Institutes. --
Using Secondary Data in Statistical Analysis. --
An Introduction to Survival Analysis. --
Measures of Function and Health Related to Quality of Life. --
Economic Analysis and Clinical Research. --
Part III: Technology Transfer, Protocol Development and Funding --
Overview of Technology Development. --
Technology Transfer. --
Telemedicine Systems. --
Animal Models of Human Disease. --
Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine. --
Preparing Scientific Images for Publication and Display. --
Writing a Clinical Protocol The Mechanics. --
Navigating the Peer Review Process for Grants. A historical perspective on clinical research / John I. Gallin --
Ethical principles in clinical research / Christine Grady --
Researching n bioethical question / Ezekiel J. Emanuel --
Integrity in research: individual and institutional responsibility / Alan N. Schechter --
Institutional review boards / Alison Wichman and Alan L. Sandler --
Data and safety monitoring boards / Lawrence M. Friedman --
Data and clinical management clinical trials / Jane Cassidy --
Unanticipated risk in clinical research / Stephen E. Straus --
The regulation of drugs and biological products by the Food and Drug Administration / Kathryn C. Zoon and Robert A. Yetter --
Legal issues / Patricia A. Kvochak --
NIH policy on the inclusion of women and minorities as subjects of clinical research / Eugene G. Hayunga and Vivian W. Pinn --
An introduction to biostatistics: randomizations, hypothesis testing, and sample size / Paul S. Albert and Craig B. Borkowf. Design and conduct of observation studies and clinical trials / Teri A. Manolio --
Small clinical trials / Mitchell B. Max --
Large clinical trials: clinical research institutes / Robert M. Califf --
Using secondary data in statistical analysis / Bradley D. Freeman, Eric P. Gerstenberger, Steven Banks, and Charles Natanson --
An introduction to survival analysis / Joanna H. Shih --
Measures of function and health-related quality of life / Lynn H. Gerber --
Economic analysis and clinical research / Martin L. Brown, Keven B. Knopf, Stephen E. Marcus, and Joseph Lipscomb --
Overview of technology development / Bruce Goldstein --
Technology transfer / James Clifford Haight --
Telemedicine systems / Kenneth M. Kempner, Frank S. Govern, and Robert Martino --
Animal models of human disease / Domenico Accili --
Conducting and evaluating clinical research on complementary and alternative medicine / Wayne B. Jonas and Klaus Linde. Preparing scientific images for publication and display / Christopher Vargas --
Writing a clinical protocol: the mechanics / Eddie Reed and Antoinette Jones-Wells --
Getting the funding you need to support your research: successfully navigating the NIH peer review process for grants / Olivia T. Preble Bartlett and Elliot Postow.
Responsibility: John I. Gallin.

Abstract:

Addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology;  Read more...

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"...this book clearly fulfills an important function for anyone involved in clinical research...this book will be accessible to a wide range of readers...this book is much needed and provides Read more...

 
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