Research Auditing

1. Research Auditing Presented by: Darlene Krueger, MBA RN CCRA Chief, GCP Auditing & Training VA Cooperative Studies Program Albuquerque, NM

2. 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

3. VA Research Auditing for Research Compliance Officers (RCOs) You are a member of one of the largest and most productive research programs in the world … VA Research & Development

4. Research Auditing Our Objective: Create a culture of compliance through accountability

5. 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.

6. 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 researchcompliance experts

7. 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.

8. 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!

9. Components of the Audit ToolReflect • Mandatory requirements for VA research Common Rule VHA 1200.5 VHA 1058.01 VHA 1108.1 VHA Directives and Handbooks FDA when applicable • Items required on Director’s Annual Report to ORO

10. Informed Consent Auditing Form • Annual audits of all active Human Subject Studies to ensure that informed consent has been properly obtained and documented

11. 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

12. Triennial Regulatory Audit Worksheet

13. 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

14. VHA Facility Director’s Annual Certification of Research Oversight Annual Reporting to ORO Informed consent and regulatory audit information have been combined on a single report form.

15. 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.

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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…

23. Thank You! Contact Information: Darlene Krueger Email:darlene.krueger@csp.research.med.va.gov Telephone: (505) 248-3203 (505) 265-1711 x16362