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Quality assurance and quality improvement handbook for human research / edited by Leslie M. Howes, Sarah A. White, Barbara E. Bierer.
Connect to full text Available online
View online- Format:
- Book
- Language:
- English
- Subjects (All):
- Clinical trials.
- Clinical trials--Standards.
- Human experimentation in medicine.
- Human experimentation in medicine--Standards.
- Quality assurance.
- Quality control.
- Clinical Trials as Topic.
- Quality Improvement--standards.
- Quality Assurance, Health Care--methods.
- Human Experimentation--standards.
- Medical Subjects:
- Clinical Trials as Topic.
- Quality Improvement--standards.
- Quality Assurance, Health Care--methods.
- Human Experimentation--standards.
- Physical Description:
- 1 online resource
- polychrome
- Place of Publication:
- Baltimore : Johns Hopkins University Press, 2019.
- System Details:
- text file
- Contents:
- 1 Introduction to Quality Assurance and Quality Improvement Programs p. 1 / Hila Bernstein and Jennifer A. Graf and Jennifer Hutchinson
- History and Evolution of QA/QI Programs p. 1
- What Is QA/QI? p. 3
- Purpose of QA/QI Programs p. 5
- Scope of QA/QI Programs p. 5
- QA/QI Programs in Practice p. 6
- 2 Types of QA/QI Programs: A Review of Three Models p. 9 / Jennifer A. Graf and Jennifer Hutchinson
- QA/QI Model Parameters p. 9
- Independent QA/QI Program p. 11
- QA/QI Function within IRB Unit p. 13
- External QA/QI Expert p. 15
- Neutrality and Objectivity p. 17
- Considerations in Hiring a QA/QI Professional p. 18
- 3 Policies and Procedures p. 21 / Barbara E. Bierer and Eunice Newhert
- Laws, Regulations, and Guidance Documents p. 22
- The Purpose of Policies and Procedures p. 23
- Policies and Procedures for QA/QI Programs p. 26
- Policies and Procedures for Other Programs within an HRPP p. 28
- 4 Investigator Site Review p. 33 / Susan Corl and Alyssa Gateman and Nareg D. Grigorian and Sarah A. White
- Types and Triggers p. 33
- Report p. 41
- QA/QI Follow-Up p. 46
- Review Closeout p. 47
- 5 Evaluating IRB Compliance p. 49 / Jennifer A. Graf and Leslie M. Howes and Cynthia Monahan and Eunice Newbert and Sarah A. White
- IRB File Review p. 49
- IRB Meeting Minutes Review p. 54
- IRB Membership Composition Review p. 57
- Post-Review Follow-Up: Documenting Observations and Sharing Results p. 60
- 6 Metrics and Communicating Observations of Noncompliance p. 63 / Leslie M. Howes and Sarah A. White
- Protocol-Specific Data p. 63
- Aggregate Data p. 64
- Identifying Best Practices p. 70
- Communicating QA/QI Findings to Different Audiences p. 70
- 7 Educational Programming p. 71 / Elizabeth Bowie and Leslie M. Howes
- Audiences p. 72
- Formats p. 72
- Common Topics Covered p. 74
- Planning and Execution p. 77
- What Next? Evaluation and Improvement p. 79.
- Notes:
- Includes bibliographical references and index.
- Electronic reproduction. Baltimore, MD Available via World Wide Web.
- Description based on online resource; title from digital title page (viewed on December 10, 2019).
- Local Notes:
- Acquired for the Penn Libraries with assistance from the Rudolph G. Schmieder Fund.
- Other Format:
- Print version:
- ISBN:
- 9781421432830
- 1421432838
- Publisher Number:
- 99984150857
- Access Restriction:
- Restricted for use by site license.
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