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KUMC Quality Assurance Program for Human Research

KUMC Quality Assurance Program for Human Research. Karen Blackwell, MS, CIP Director, Human Research Protection Program. Overview. Rationale for proposing a QA program Activities of the QA Task Force Task Force recommendations Next steps. Quality Assurance….

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KUMC Quality Assurance Program for Human Research

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  1. KUMC Quality Assurance Program for Human Research Karen Blackwell, MS, CIP Director, Human Research Protection Program

  2. Overview • Rationale for proposing a QA program • Activities of the QA Task Force • Task Force recommendations • Next steps

  3. Quality Assurance… • Support and education for investigators • Routine on-site reviews of study records • Preparation for external audits • For-cause audits, when required • Feedback to the overall HRPP

  4. Rationale for a QA Program • Reflect our commitment to excellence • Coordinate efforts within KUMC • Prevent compliance violations • Meet contractual and fiduciary duties • Address known challenges

  5. EVC’s Charge to the Task Force • Examine model programs • Identify key individuals and groups • Optimize existing resources • Develop standard operating procedures • Establish reporting paths • Develop a communication plan • Report back by September 1st

  6. Ed Phillips Jeff Reene Paul Terranova Marge Bott Gary Doolittle Patty Kluding Greg Kopf Karen Blackwell Jo Denton Diana Naser Becky Hubbell Monica Lubeck QA Task Force MembersApril –August 2009

  7. Model Programs • University of Pittsburgh • Partners HealthCare System • University of Michigan • Emory University • Indiana University • University of California – San Francisco • Baylor College of Medicine • Children’s Hospital of Boston

  8. Task Force Recommendations • Overall philosophy for our program • Key components of a QA program • Resources, milestones, timelines • Leadership and oversight

  9. Key Components • Support from institutional leadership • Clear delineation of roles • Transparent criteria for study selection • Standard operating procedures • Lines of authority to report audit findings • Methods to translate findings into education and support for investigators

  10. Philosophy of the QA Program • Partnership • Focus on education and assistance • Collegial approach • Soliciting investigator feedback

  11. Appendix C

  12. Appendix D

  13. Evaluating Resources

  14. Recommended Milestones • Aim for 5 – 8% of our 1020 studies • 5% = 51 reviews annually; 8% = 81 reviews • 1st year 2.5%; 2nd year: 5 – 8% • Minimum staff of 2 FTEs • As research volume grows, adjust staff to maintain the 5 – 8% target

  15. Input and Oversight • Model programs recommended ongoing faculty input • Guidance from the Clinical Research Advisory Committee • Oversight by executive leadership: • Vice Chancellor for Administration • Vice Chancellor for Research • RI Executive Director

  16. Task Force Report to EVC Presentations to leadership and investigators Final versions of Standard Operating Procedures Solicitation of investigators for voluntary reviews Program Launch Six-month program evaluations Annual reports to the EVC and CRAC September 2009 October – December 2009 November – December 2009 November – December 2009 January 2010 June 2010, Jan 2011, June 2011 January 2011, January 2012 Timelines

  17. Implementation:Study selection On-site review Feedback Corrections as needed Trend analysis

  18. Study Selection Tier 1 • Federally or internally funded • Moderate to high risk • IND/IDE holders • KUMC role as coordinating center • Vulnerable populations • COI Tier 2(other studies)

  19. Review Process • PI is notified • Review is scheduled ~ 2 weeks • On-site review • Routine reviews, 20 – 30% of records • For-cause, up to 100%

  20. Scope of the Review • IRB-approved documents • Signed consent forms • Study data, e.g., • Inclusion/exclusion decisions • Outcomes of assessments and procedures • Source documents • Adverse events or problems • Drug/Device accountability

  21. Common Findings at Other Sites • Missing correspondence or approvals • Informed consent issues • Expired or invalid consents • Not dated or signed correctly • Consent by unauthorized persons • Incomplete study records

  22. Serious Findings • Protocol non-compliance • Inadequate study records • Unreported adverse events or deviations • Lack of drug/device accountability • Unapproved research

  23. Observations and Corrections • Exit interview • Draft report to the PI, within 7 days • PI responds with corrections of errors, clarifications, corrective action plan (if needed), within 14 days • Final report to the PI and to the HSC

  24. Reporting Findings • All final reports go to the HSC office • Minor non-compliance is reviewed by the chair • Potentially serious non-compliance goes to the convened HSC • Evaluate corrective action plans • Follow-up as appropriate

  25. Getting Feedback • Exit interviews • Survey to investigators • Input from the CRAC • Cumulative results impact overall program

  26. Feedback?Questions?

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