Quality Assurance and Quality Improvement Handbook for Human Research

Author:   Leslie M. Howes ,  Sarah A. White ,  Barbara E. Bierer
Publisher:   Johns Hopkins University Press
ISBN:  

9781421432823


Pages:   240
Publication Date:   05 November 2019
Format:   Paperback
Availability:   Not yet available   Availability explained
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

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Quality Assurance and Quality Improvement Handbook for Human Research


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Overview

Quality Assurance and Quality Improvement Handbook for Human Research is the first comprehensively designed instructional manual aimed at teaching human research protection program (HRPP) professionals how to create, implement, evaluate, and improve QA/QI programs. Geared toward institutions and individuals responsible for establishing new QA/QI programs or functions, the book offers several organizational models for consideration. It also provides practical information for improving and strengthening established programs, both big and small. Written in a conversational style, the book's step-by-step instructions make it easily accessible to those who may not be well versed in QA/QI concepts and fundamentals. Developed by the QA/QI Subcommittee of the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program, which is committed to designing and strengthening QA/QI programs and functions, this volume * includes contributions by fifteen experts with diverse professional experiences from varied organizations * is enhanced with flow charts, examples, sample forms, and templates* incorporates model slide presentations and instructional materials* discusses the respective benefits and challenges of different organizational models* is applicable across many organizational types with a variety of reporting structures and available resources, including academic and medical institutions Perfect for both seasoned personnel and newcomers to the field, Quality Assurance and Quality Improvement Handbook for Human Research is a needed resource for ensuring investigative accountability. Contributors: Hila Bernstein, MS, MPH, Barbara E. Bierer, MD, Elizabeth Bowie, JD, MPH, MSc, Susan Corl, MSW, MPH, CIP, CCRP, Jacquelyn-My Do, MPH, Lisa Gabel, CIP, Alyssa Gateman, MPH, CCRP, Jennifer A. Graf, Nareg D. Grigorian, Leslie M. Howes, MPH, CIP, Jennifer Hutchinson, CIP, CPIA, Cynthia Monahan, MBA, CIP, Eunice Newbert, MPH, Sarah A. White, MPH, CIP, Elizabeth Witte, MFA

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:   05 November 2019
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Not yet available   Availability explained
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

Table of Contents

Contributors Foreword Preface AcknowledgmentsNote to Readers Chapter 1. Introduction to Quality Assurance and Quality Improvement ProgramsHila Bernstein, Jennifer A. Graf, and Jennifer HutchinsonChapter 2. Types of QA/QI Programs: A Review of Three ModelsJennifer A. Graf and Jennifer HutchinsonChapter 3. Policies and ProceduresBarbara E. Bierer and Eunice NewbertChapter 4. Investigator Site ReviewSusan Corl, Alyssa Gateman, Nareg D. Grigorian, and Sarah A. WhiteChapter 5. Evaluating IRB ComplianceJennifer A. Graf, Leslie M. Howes, Cynthia Monahan, Eunice Newbert, and Sarah A. WhiteChapter 6. Metrics and Communicating Observations of NoncomplianceLeslie M. Howes and Sarah A. WhiteChapter 7. Educational ProgrammingElizabeth Bowie and Leslie M. HowesAppendix 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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