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Full Product Details

Author:   Leslie M. Howes ,  Sarah A. White ,  Barbara E. Bierer
Publisher:   Johns Hopkins University Press
Imprint:   Johns Hopkins University Press
Dimensions:   Width: 15.20cm , Height: 1.50cm , Length: 22.90cm
Weight:   0.408kg
ISBN:  

9781421432823

ISBN 10:   142143282
Pages:   240
Publication Date:   31 December 2019
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Out of stock  
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Table of Contents

Contributors Foreword Preface Acknowledgments Note to Readers Chapter 1. Introduction to Quality Assurance and Quality Improvement Programs Hila Bernstein, Jennifer A. Graf, and Jennifer Hutchinson Chapter 2. Types of QA/QI Programs: A Review of Three Models Jennifer A. Graf and Jennifer Hutchinson Chapter 3. Policies and Procedures Barbara E. Bierer and Eunice Newbert Chapter 4. Investigator Site Review Susan Corl, Alyssa Gateman, Nareg D. Grigorian, and Sarah A. White Chapter 5. Evaluating IRB Compliance Jennifer A. Graf, Leslie M. Howes, Cynthia Monahan, Eunice Newbert, and Sarah A. White Chapter 6. Metrics and Communicating Observations of Noncompliance Leslie M. Howes and Sarah A. White Chapter 7. Educational Programming Elizabeth Bowie and Leslie M. Howes Appendix A. Abbreviations and Acronyms Appendix B. Resources

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Author Information

Leslie M. Howes, MPH, CIP, is the director of the Office of Regulatory Affairs and Research Compliance for the Harvard Longwood Medical Area Schools. Sarah A. White, MPH, CIP, is the executive director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. Barbara E. Bierer, MD, is the faculty director of the Multi-Regional Clinical Trials Center, a professor of medicine at Harvard Medical School and Brigham and Women's Hospital, and the director of the Regulatory Foundations, Ethics, and Law Program at Harvard Catalyst / The Harvard Clinical and Translational Science Center.

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