Quality Assurance and Quality Improvement Handbook for Human Research
Will be published approx. on 31. December 2019
Book
Paperback/Softback
240 pages
978-1-4214-3282-3 (ISBN)
Description
Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs.
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
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
More details
Language
English
Place of publication
Baltimore, MD
United States
Target group
Professional and scholarly
Product notice
Paperback (trade)
Illustrations
15 s/w Zeichnungen
15 Line drawings, black and white
Dimensions
Height: 226 mm
Width: 150 mm
Thickness: 15 mm
Weight
318 gr
ISBN-13
978-1-4214-3282-3 (9781421432823)
DOI
10.1353/book.68016
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Leslie M. Howes | Sarah A. White | Barbara E. Bierer
Quality Assurance and Quality Improvement Handbook for Human Research
E-Book
12/2019
Johns Hopkins University Press
€72.99
Available for download
Persons
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.
Content
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
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