Quality Assurance and Quality Improvement Handbook for Human Research

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

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.