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

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?