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

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 Target for % of studies reviewed Routine Reviews per Year FTEsAnnual Routine Reviews per FTE Team or Single Institution 15%None. Currently focusing on for-cause audits 3.5n/aTeams when needed Institution 22%1 st year: 30 2 nd year: 70 3 rd year: 85 2.336Single reviewer Institution 38%100 – 1103.5 and Hiring 2 more FTEs 31Teams of 2 or 3 Institution 410%200+540Single reviewer

14. Recommended Milestones Aim for 5 – 8% of our 1020 studies 5% = 51 reviews annually; 8% = 81 reviews 1 st year 2.5%; 2 nd 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. Timelines 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 January 2010 June 2010, Jan 2011, June 2011 January 2011, January 2012

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?