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El. knyga: Quality Assurance and Quality Improvement Handbook for Human Research

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  • Formatas: PDF+DRM
  • Išleidimo metai: 05-Nov-2019
  • Leidėjas: Johns Hopkins University Press
  • Kalba: eng
  • ISBN-13: 9781421432830
Kitos knygos pagal šią temą:
Quality Assurance and Quality Improvement Handbook for Human ResearchDidesnis paveikslėlis
  • Formatas: PDF+DRM
  • Išleidimo metai: 05-Nov-2019
  • Leidėjas: Johns Hopkins University Press
  • Kalba: eng
  • ISBN-13: 9781421432830
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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

Daugiau informacijos

Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs.
Contributors xi
Foreword xiii
Preface xvii
Acknowledgments xxi
Note to Readers xxiii
1 Introduction to Quality Assurance and Quality Improvement Programs
1(8)
Hila Bernstein
Jennifer A. Graf
Jennifer Hutchinson
History and Evolution of QA/QI Programs
1(2)
What Is QA/QI?
3(2)
Purpose of QA/QI Programs
5(1)
Scope of QA/QI Programs
5(1)
QA/QI Programs in Practice
6(3)
2 Types of QA/QI Programs: A Review of Three Models
9(12)
Jennifer A. Graf
Jennifer Hutchinson
QA/QI Model Parameters
9(2)
Independent QA/QI Program
11(2)
QA/QI Function within IRB Unit
13(2)
External QA/QI Expert
15(2)
Neutrality and Objectivity
17(1)
Considerations in Hiring a QA/QI Professional
18(3)
3 Policies and Procedures
21(12)
Barbara E. Bierer
Eunice Newbert
Laws, Regulations, and Guidance Documents
22(1)
The Purpose of Policies and Procedures
23(3)
Policies and Procedures for QA/QI Programs
26(2)
Policies and Procedures for Other Programs within an HRPP
28(1)
Points to Consider
28(5)
4 Investigator Site Review
33(16)
Susan Corl
Alyssa Gateman
Nareg D. Grigorian
Sarah A. White
Types and Triggers
33(1)
Process
34(7)
Report
41(5)
QA/QI Follow-Up
46(1)
Review Closeout
47(2)
5 Evaluating IRB Compliance
49(14)
Jennifer A. Graf
Leslie M. Howes
Cynthia Monahan
Eunice Newbert
Sarah A. White
IRB File Review
49(5)
IRB Meeting Minutes Review
54(3)
IRB Membership Composition Review
57(3)
Post-Review Follow-Up: Documenting Observations and Sharing Results
60(3)
6 Metrics and Communicating Observations of Noncompliance
63(8)
Leslie M. Howes
Sarah A. White
Protocol-Specific Data
63(1)
Aggregate Data
64(6)
Identifying Best Practices
70(1)
Communicating QA/QI Findings to Different Audiences
70(1)
7 Educational Programming
71(10)
Elizabeth Bowie
Leslie M. Howes
Scope
71(1)
Audiences
72(1)
Formats
72(2)
Common Topics Covered
74(3)
Planning and Execution
77(2)
What Next? Evaluation and Improvement
79(2)
Appendix A Abbreviations and Acronyms
81(2)
Appendix B Resources
83(76)
Chapter 2 Job Description: QA/QI Specialist
83(2)
Chapter 3 Policy Manual Template
85(4)
Sample SOP: Directed Audit (For-Cause Audit)
89(2)
Sample SOP: Routine On-Site Review (Not-for-Cause Audit)
91(2)
Chapter 4 Audit Certificate Template
93(1)
Investigator Site Review Report Template
94(2)
Short Audit Spot Check Template
96(2)
PI Notification Letter Template
98(2)
PI Response Form Template
100(2)
PI Site Review Summary Template
102(4)
Observation Index
106(6)
Model Audit Tool
112(40)
Chapter 5 IRB Meeting Minutes Checklist
152(5)
IRB Membership Composition Audit Checklist
157(2)
Appendix C Investigator Toolkit
159(52)
Note-to-File Template
159(1)
Regulatory Binder Tabs Template
160(21)
Investigator Self-Assessment
181(17)
External Audit Prep Checklist
198(4)
Logs. Delegation of Responsibility
202(1)
Human Research Training
203(1)
Investigational Device Accountability
204(1)
Investigational Drug Accountability
205(1)
Reportable New Information
206(2)
Site Screening and Enrollment
208(1)
Study Monitoring
209(2)
Bibliography 211(2)
Index 213
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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