Research Auditing

Presented by:

Darlene Krueger, MBA RN CCRA Chief, GCP Auditing & Training VA Cooperative Studies Program Albuquerque, NM

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Points of Discussion

• Auditing Perspective & Objectives

• Auditing Standardization and Forms

• Items Selected for Inclusion

• Tips – Making it Work for You

• Improving the Tool

• Resources to Meet the Challenge

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VA Research Auditing for Research Compliance Officers (RCOs)

You are a member of one of the largest and You are a member of one of the largest and

most productive research programs in the most productive research programs in the

world … world … VA Research & DevelopmentVA Research & Development

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Research Auditing

Our Objective:

Create a culture of compliance

through accountability

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Research Auditing for Human Studies

• Conduct audits and reviews to ensure compliance with all VA and other Federal requirements for the conduct of research including• Annual Informed Consent Audits of all

active studies to ensure that informed consent has been properly obtained and documented for each subject since the previous audit, and

• Regulatory Compliance Audits for all active studies at least every 3 years.

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Standardization of Audit Methodology

• Achieve consistent results VA-wide • Facilitate data collection and reporting• Allow for trending of findings to identify

issues and make improvements system-wide

• Develop large cross-trained pool of research compliance experts

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Development of the Research Audit Worksheet

The Office of Research Oversight RCO Advisory Group was created to develop effective methods to assist RCOs in meeting the newly established auditing requirements.

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Development of the Research Audit Worksheet The Office of Research Oversight

RCO Advisory Group

• Joan Porter Office Research Oversight (ORO)• Paula Waterman Office Research Oversight

(ORO)• Beth Gibbs VISN 7 (RCO) • Mary Costigan VAMC Philadelphia (RCO)• Darlene Krueger VA Cooperative Studies Program

Additional RCOs as Advisory Group Reviewers Membership will be expanded in the future!

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Components of the Audit ToolReflect

• Mandatory requirements for VA research

Common RuleVHA 1200.5VHA 1058.01VHA 1108.1VHA Directives and HandbooksFDA when applicable

• Items required on Director’s Annual Report to ORO

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Informed Consent Auditing Form

• Annual audits of all active Human Subject Studies to ensure that informed consent has been properly obtained and documented

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Elements of Consent Auditing Worksheet

• Version of Informed Consent Document (ICD) signed

• Current ICD signed • Subject Signature Present & Dated • Witness Signature Present & Dated • Date & Signature of Person Obtaining Consent present • “Authorized” Person Obtained Consent• ICD Contains IRB Approval Stamp • HIPAA Authorization Obtained • Consent noted in CPRS

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Triennial Regulatory Audit Worksheet

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Regulatory Audit Worksheet Sections

• Administrative Information Section• IRB Submissions, Approvals, Notifications• Unanticipated Problems Involving Risks• Significant Safety Reports /DMC Reports• Study Team Qualifications & Training• Subject Records Review • Protocol Deviations• Investigator Oversight• Investigational Product Accountability• Document Management Summary

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VHA Facility Director’s Annual Certification of Research Oversight

Annual Reporting to ORO Informed consent andregulatory auditinformation have beencombined on a singlereport form.

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Adaptation of Audit Worksheets

• Audit Forms provide the minimum requirements for the informed consent and regulatory review.

• Acceptable to add items/pages to meet unique needs of your program.

• Caution: Do not delete any audit items on the worksheet provided by ORO.

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RCO Tool Kit – Optional Forms

• Supplemental Forms (prn) for special situations or areas of concern:• Pharmacy Records Review Form

• Site Signature and Delegation of Responsibility Log

• Observing the Consent Process

• VA CSP SMART Web site/ Forms and Tools

Work in progress

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Improving the Research Audit Tool

• Current tool is to be used for first round of audits (January 1 – May 31, 2009)

• On-going feedback from RCOs is critical

• ORO and the Advisory Group to reconvene, review, and revise as needed

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Tips for Getting Started

Considerations for Prioritizing Studies for Audit

• Studies that involve more than minimal risk

• Investigators with a history of serious non-compliance

• Investigator-Initiated Studies

• Studies with significant issues reported by Sponsor Monitors

• Investigators conducting numerous studies

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Assuring Compliance

Build rapport and gain buy-in by empowering the Investigator to succeed

• Provide Tools and Training• Serve as an Enthusiastic Resource• Be Proactive - Consider an Investigator-RCO

meeting prior to study start providing clear expectations for compliance

• Foster mentoring between stellar Study Coordinators and less experienced personnel

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Assuring Compliance

• Audit tools and checklists alone do not assure compliance• Audits

• Walk-arounds

• Communicate regularly with staff, investigators, management, and other key players

• Situational awareness

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Resources Available to the RCO

• ORO RCO Education Program• RCO ListServ• Mentoring Colleagues• ORO RCO Webpage

(http://www1.va.gov/oro/)

• RCO Guidance & Toolkit (in development)

• Future standards and tools will be provided for animal research

Resources in Development

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VA Leadership has made it clear . . .

RESEARCH COMPLIANCE IS

THE PRIORITY

The new auditing initiative may appear daunting, but its potential impact on the quality of VA research is

unprecedented . . . These are exciting times!

In Conclusion…

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Thank You!

Contact Information:

Darlene Krueger Email: darlene.krueger@csp.research.med.va.gov

Telephone: (505) 248-3203

(505) 265-1711 x16362