Quality assessment and quality improvement handbook for human research

Quality assessment and quality improvement handbook for human research /

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Bibliographic Details
Corporate Author: ProQuest (Firm)
Other Authors: Howes, Leslie (Editor), White, Sarah A., MPH (Editor), Bierer, Barbara E. (Editor)
Format: Electronic eBook
Language:English
Published: Baltimore, Maryland : Johns Hopkins University Press, [2019]
Subjects:
Clinical trials > Standards.
Human experimentation in medicine > Standards.
Quality control.
Clinical Trials as Topic.
Human Experimentation > standards.
Quality Assurance, Health Care > methods.
Quality Improvement > standards.
Online Access:Connect to this title online (unlimited simultaneous users allowed; 325 uses per year)

MARC

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020 |a 1421432838 (electronic bk.) 
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245 0 0 |a Quality assessment and quality improvement handbook for human research /  |c edited by Leslie M. Howes, Sarah A. White, Barbara E. Bierer. 
264 1 |a Baltimore, Maryland :  |b Johns Hopkins University Press,  |c [2019] 
300 |a 1 online resource (xxii, 216 pages) :  |b illustrations. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
504 |a Includes bibliographical references and index. 
505 0 0 |a Machine generated contents note:   |g 1.  |t Introduction to Quality Assurance and Quality Improvement Programs /  |r Jennifer Hutchinson --   |t History and Evolution of QA/QI Programs --   |t What Is QA/QI? --   |t Purpose of QA/QI Programs --   |t Scope of QA/QI Programs --   |t QA/QI Programs in Practice --   |g 2.  |t Types of QA/QI Programs: A Review of Three Models /  |r Jennifer Hutchinson --   |t QA/QI Model Parameters --   |t Independent QA/QI Program --   |t QA/QI Function within IRB Unit --   |t External QA/QI Expert --   |t Neutrality and Objectivity --   |t Considerations in Hiring a QA/QI Professional --   |g 3.  |t Policies and Procedures /  |r Eunice Newbert --   |t Laws, Regulations, and Guidance Documents --   |t Purpose of Policies and Procedures --   |t Policies and Procedures for QA/QI Programs --   |t Policies and Procedures for Other Programs within an HRPP --   |t Points to Consider --   |g 4.  |t Investigator Site Review /  |r Sarah A. White --   |t Types and Triggers --   |t Process --   |t Report --   |t QA/QI Follow-Up --   |t Review Closeout --   |g 5.  |t Evaluating IRB Compliance /  |r Sarah A. White --   |t IRB File Review --   |t IRB Meeting Minutes Review --   |t IRB Membership Composition Review --   |t Post-Review Follow-Up: Documenting Observations and Sharing Results --   |g 6.  |t Metrics and Communicating Observations of Noncompliance /  |r Sarah A. White --   |t Protocol-Specific Data --   |t Aggregate Data --   |t Identifying Best Practices --   |t Communicating QA/QI Findings to Different Audiences --   |g 7.  |t Educational Programming /  |r Leslie M. Howes --   |t Scope --   |t Audiences --   |t Formats --   |t Common Topics Covered --   |t Planning and Execution --   |t What Next? Evaluation and Improvement --   |g Appendix A   |t Abbreviations and Acronyms --   |g Appendix B   |t Resources --   |g ch. 2   |t Job Description: QA/QI Specialist --   |g ch. 3   |t Policy Manual Template --   |t Sample SOP: Directed Audit (For-Cause Audit) --   |t Sample SOP: Routine On-Site Review (Not-for-Cause Audit) --   |g ch. 4   |t Audit Certificate Template --   |t Investigator Site Review Report Template --   |t Short Audit Spot Check Template --   |t PI Notification Letter Template --   |t PI Response Form Template --   |t PI Site Review Summary Template --   |t Observation Index --   |t Model Audit Tool --   |g ch. 5   |t IRB Meeting Minutes Checklist --   |t IRB Membership Composition Audit Checklist --   |g Appendix C   |t Investigator Toolkit --   |t Note-to-File Template --   |t Regulatory Binder Tabs Template --   |t Investigator Self-Assessment --   |t External Audit Prep Checklist --   |t Logs. Delegation of Responsibility --   |t Human Research Training --   |t Investigational Device Accountability --   |t Investigational Drug Accountability --   |t Reportable New Information --   |t Site Screening and Enrollment --   |t Study Monitoring. 
533 |a Electronic reproduction.  |b Ann Arbor, MI  |n Available via World Wide Web. 
588 |a Description based on print version record. 
650 0 |a Clinical trials  |x Standards. 
650 0 |a Human experimentation in medicine  |x Standards. 
650 0 |a Quality control. 
650 1 2 |a Clinical Trials as Topic. 
650 2 2 |a Human Experimentation  |x standards. 
650 2 2 |a Quality Assurance, Health Care  |x methods. 
650 2 2 |a Quality Improvement  |x standards. 
700 1 |a Howes, Leslie,  |e editor. 
700 1 |a White, Sarah A.,  |c MPH,  |e editor. 
700 1 |a Bierer, Barbara E.,  |e editor. 
710 2 |a ProQuest (Firm) 
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856 4 0 |u https://ebookcentral.proquest.com/lib/santaclara/detail.action?docID=5899524  |z Connect to this title online (unlimited simultaneous users allowed; 325 uses per year)  |t 0 
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