1. 1 Auditing and Monitoring Gerald Beccia/RCO VA CT Healthcare System

2. 2 Presentation Overview Responsibility and Authority Choosing Indicators Protocol Audits –Types of Protocol Audits –Choosing Protocols –Audit Preparation –Audit Process –Follow-up QA vs. QI

3. 3 Responsibility VHA Handbook 1200.5 Paragraph 5 – MEDICAL CENTER DIRECTOR RESPONSIBILITES Section a(5) - Every Medical Center Director is responsible for developing and monitoring procedures to ensure the safety of subjects in research either directly or by delegating the responsibility to other qualified VA staff.

4. 4 Authority VHA Handbook 1200.5 Paragraph 7 – IRB RESPONSIBILITES AND AUTHORITY Section e - AUDITING RECURRING PROCESSES 1.Conduct audits of recurring processes to be sure that all written procedures are followed 2.Review research records and research case histories for compliance with written procedures and regulations contained in this Handbook 3.Monitor the informed consent process and the research, and 4.Consider results of audits conducted by other entities within the institution

5. 5 It’s an unfortunate fact of life that there are many things that can put research subjects at risk and literally dozens of items that can get you into serious trouble with literally dozens of organizations What to audit?

6. 6 What to Audit? (things to consider) Audit Motivation Auditor’s Skills and Competencies Organizational Vulnerabilities Regulatory Hot Spots What data is already “out there” and available for your use.

7. 7 What to Audit? (things to remember) Audits should encompass as many components of the HRPP program as possible Variability is a Virtue (broadens the scope and lessens the boredom )

8. 8 Protocol Audits Types of Audits Choosing Protocols Preparation The Audit Process Follow-ups

9. 9 Protocol Audits (types of audits) For Cause Audits –RCO –ACOS/R –Medical Center Director –IRB Chair Random Audits –RCO

10. 10 Protocol Audits (choosing protocols) High or Moderate Risk Vulnerable Subjects Enrollment Status –Actively enrolling –Currently enrolling PI Experience & History

11. 11 Protocol Audits (preparation) ● Get access to and learn how to use CPRS ● Know your protocol history Decide in advance what protocol specific items you will be looking for Develop a protocol specific audit tool Do as much as possible in advance, i.e. from your desk using CPRS (leaves far more time for discussion and education)

12. 12 Protocol Audits (the process) Notification and Scheduling ● Preliminary Briefing Audit ● PI Notification – Response expected ● Written Report -To: Medical Center Director - cc: IRB/R&D ● Verbal Summary of Report at IRB Meeting ● Copy of Report to PI

13. 13 PI Study # Title Initial HSS Appr Last CR Date Ref Dates # Enrolled # Files Reviewed 10/21/049/15/05Sep 05 – May 06264 4/1/041/19/06Jan 06 – May 0644 7/21/05NAJul 05 – May 0633 Background Information

14. 14 PI Study # Title Reporting of all AEs Reporting of all Deviations Adherence to Protocol Compliance w/ Inclusion/Exclusion Criteria Met Not Met 1 Met 1 “ …………………………..” AEs, Deviations, Inclusion/Exclusion Criteria, Adherence to Protocol

15. 15 Protocol Audits (what I review) Consent Forms Research Alerts Adverse Events Deviations/Adherence to Protocol Inclusion/Exclusion Criteria

16. 16 Follow-up Reports Every six months (approximately) Focus on events or issues identified in previous audits Purpose: –Assure that PI action items were completed –Assure that interventions established to correct errors or omissions were effective

17. 17 Responsibility VHA Handbook 1200.5 Paragraph 7 – IRB RESPONSIBILITES AND AUTHORITY Section d - Maintaining Written Procedures for Operations Bullet #9 - The IRB must establish written procedures for conducting audits of protocols and other IRB activities

18. 18 QA vs. QI AAHRPP element I.3.L – The organization implements a plan to measure and improve HRPP effectiveness, quality 1, and compliance with organizational policies 2 and procedures and applicable federal, state, or local laws. 1 = QI2 = QA AAHRPP Commentary:

19. 19 Gerald Beccia/RCO VA Connecticut Healthcare Tel: (203) 932-5711 ext. 5772 Gerald.Beccia@.va.gov

20. 20 ?

21. 21