April 21 23, 2004

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Research Compliance Auditing
Caroline Fultz-Carver, Ph.D., M.H.A Quality
Assurance Program Assistant Director USF
Research Compliance
Barry Bercu, M.D. Chair, USF Biomedical
IRB Professor of Pediatrics, Biochemistry and
Molecular Biology, Pharmacology and
Therapeutics College of Medicine
April 21 23, 2004 Baltimore, Maryland
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Overview
Overview of USF IRB History of USF Human
Subject Protections Program USF Auditing
Program Recommendations for a Successful
Program Pearls for Developing a Robust,
Credible Audit Program
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Human Subject Protections Program
Average Active Protocols (n1500) Biomedical
Studies (ngt800) Weekly Biomedical IRB Meetings
IRB Professional Support (20 FTEs)
Assistant Directors-IRB and Quality Assurance
(n2) Coordinators-Biosafety, IRB, HIPAA, and
Education (n4) Senior Grant Specialists
(n8) Grant Assistants (n2) Program
Assistants (n4) Budget ? 1,300,000
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History of USF Audit Program
Established in March 2002 with 1 FTE (currently
2 FTEs) Completed Audits to Date (n9) Common
Deficiencies/Findings Informed Consent (IC)
Documentation Missing pages, signatures,
dates Subject consented with wrong version
Subject Records Organization No documentation
to demonstrate adherence to IRB-approved
protocol Research Records Organization
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USF Audit Program Plans for Next year
Increase Number Audits Completed Annually
For-Cause (average 4/year) Randomly-Selected
(4/year)
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USF Audit Process Summary
Pre-Evaluation
Post-Evaluation
Evaluation
Pre- Evaluation Interview
IC Process Review
Adverse Events Analysis
Evaluation Report Preparation
Subject Records Selection
IC Document Review
Research Records Review
Evaluation Report Review
Approval Period Analysis
Protocol Adherence Analysis
Evaluation Report Dissemination
Continuing Review Analysis
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Pre-EvaluationInterviews and IRB File Review
Pre- Evaluation Interview
Meeting with Principal Investigator (PI) and
coordinator to review auditing process and
schedule
Subject Records Selection
Random selection of subject records based on
randomization algorithm
Review of IRB approval letters to ensure no
lapses in IRB approval and ensure no subjects
enrolled during lapses in IRB approval
Approval Period Analysis
Continuing Review Analysis
Review of continuing review (CR) applications to
ensure PI compliance with CR submissions policies
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EvaluationOn-Site Records Review
IC Process Review
Interview with PI and coordinator to review
informed consent process
Review of informed consent documentation for
completeness (all pages present, appropriately
signed and dated)
IC Document Review
Review of subject records (subject binders, case
report forms, medical records, etc.) for evidence
of adherence to the IRB-approved protocol
Protocol Adherence Analysis
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EvaluationOn-Site Records Review (contd)
Review of adverse events reports to IRB to ensure
reporting policies met and, if still enrolling
subjects, ICF contact information valid
Adverse Events Analysis
Review of informed consent documentation for
completeness (all pages present, appropriately
signed and dated)
Research Records Review
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Post-EvaluationReport Preparation and
Dissemination
Evaluation Report Preparation
Summation of audit findings and, when needed,
clarification of specific issues with PI
Evaluation Report Review
Review of audit findings with PI, includes time
for PI response and any necessary
updates/corrections to report
Distribution to PI and followed by discussion and
vote by IRB
Evaluation Report Dissemination
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USF Audit Process Summary
Pre-Evaluation
Post-Evaluation
Evaluation
Pre- Evaluation Interview
IC Process Review
Adverse Events Analysis
Evaluation Report Preparation
Subject Records Selection
IC Document Review
Research Records Review
Evaluation Report Review
Approval Period Analysis
Protocol Adherence Analysis
Evaluation Report Dissemination
Continuing Review Analysis
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Recommendations for a Successful Program
Audit Program Implementation and Management
Clear Communication with Stakeholders
Documentation requirements Audit
process/timetable Process Objectivity
Investigators Complete Records for Each
Enrolled Subject Organize Records
(Chronological by Study Number) Open
Communication with Auditors to Ensure
Understanding of Record-Keeping Expectations
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Pearls
Effective communication with stakeholders
critical PI, IRB members, University
officials, and, when applicable, Affiliate
Institutions Balancing collegiality with
accountability
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Summary
Elements for Successful Program Reviewed
Emphasis on Partnership Among Investigators,
Coordinators, IRB Staff, and IRB Chair Need
for Dedicated Individuals to Address Audit
Volume (For-Cause and Randomly- Selected)
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Contacts
Division of Research Compliance
Web site http//www.research.usf.edu/cs/ Phone (
813) 974-5638 Mail USF Division of Research
Compliance 12901 Bruce B. Downs Blvd., MDC
035 Tampa, FL 33612-4799
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Contacts (cont.)
Division of Research Compliance
Caroline Fultz-Carver, Ph.D., M.H.A Quality
Assurance Program Assistant Director USF
Research Compliance [phone] cfcarver_at_resea
rch.usf.edu
Barry Bercu, M.D. Chair, USF Biomedical
IRB Professor of Pediatrics, Biochemistry and
Molecular Biology, Pharmacology and
Therapeutics College of Medicine (813)
974-5638 bbercu_at_research.usf.edu