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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…
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
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
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
QA Task Force MembersApril –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
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
Task Force Recommendations
Overall philosophy for our program
Key components of a QA program
Resources, milestones, timelines
Leadership and oversight
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
Philosophy of the QA Program
Partnership
Focus on education and assistance
Collegial approach
Soliciting investigator feedback
Appendix C
Appendix D
Evaluating ResourcesTarget for
% of studies
reviewed
Routine Reviews per Year
FTEs Annual Routine Reviews per FTE
Team or Single
Institution 1 5% None. Currently
focusing on for-cause
audits
3.5 n/a Teams when needed
Institution 2 2% 1st year: 302nd year: 703rd year: 85
2.3 36 Single reviewer
Institution 3 8% 100 – 110 3.5 and Hiring 2
more FTEs
31 Teams of 2 or 3
Institution 4 10% 200+ 5 40 Single reviewer
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
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
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 2009October – December 2009
November – December 2009
November – December 2009
January 2010
June 2010, Jan 2011, June 2011
January 2011, January 2012
Implementation:Study selectionOn-site reviewFeedbackCorrections as neededTrend analysis
Study SelectionTier 1
Federally or internally funded Moderate to high risk IND/IDE holders KUMC role as coordinating center Vulnerable populations COI
Tier 2 (other studies)
Review Process PI is notified Review is scheduled ~ 2 weeks On-site review
Routine reviews, 20 – 30% of records For-cause, up to 100%
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
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
Serious Findings
Protocol non-compliance Inadequate study records Unreported adverse events or deviations Lack of drug/device accountability Unapproved research
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
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
Getting Feedback
Exit interviews Survey to investigators Input from the CRAC Cumulative results impact overall
program
Feedback?
Questions?