1. Internal Auditing in Research: The QA Process Research Education Series February 14, 2011 Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist Heather Kemp, MBA, CCRP, Clinical Research Coordinator Department of Surgery, General Surgery Section

2. Agenda / Overview Assessing Risk in Auditing The SOP: Answering the Who, What, Where, When, Why, and How of Internal Auditing The Coordinator’s Perspective: Before, During, and After an Internal Audit

3. The Research Context Operational Oversight Finance Non- Therapeutic Operations Biospecimen Repositories Educational Research Imaging Research Research Databases Regulatory Therapeutic Operations Investigational Drug, Devices, and Procedures Nursing IUH North Hospital IUH University Hospital IUH West Hospital VA Medical Center Wishard Hospital Data Management

4. The Research Context Budgeting, Grants and Contracts, Account Management 1 Staff Member with Responsibilities in this Area 0.5 FTE Finance Subject Consenting, Specimen Collection and Processing, Hospital Staff Training, Data Collection and Management, Data Analysis, Manuscript Publication 6 Staff Members with Responsibilities in this Area 2.25 FTE Non-Therapeutic Operations Protocol Development, Regulatory Approvals (IRB, VA R&D, etc.), Regulatory Document Collection and Maintenance, Internal Auditing 2 Staff Members with Responsibilities in this Area 1.25 FTE Regulatory Subject Screening/Consenting/Enrollment/Management, Hospital Staff Training, Data Collection and Management, Data Analysis, Manuscript Publication 7 Staff Members with Responsibilities in this Area 5.0 FTE Therapeutic Operations

5. Answer the questions in Section I (page 1) of your handout to assess the context of your research group.

6. Why is it Audited? Compliance Process Improvement Education

7. Who is Audited? All research which: – Is not exempt from IRB review; – Is not being conducted under a waiver of informed consent; – Has subjects enrolled on the study; and – Has not been reviewed by the Clinical Trials Monitoring Committee in the past 12 months.

8. What is Audited? Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP

9. Sponsored Trials: Exceptions to the Rule Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP

10. Other Resources 1.Toward, J. (2010, November). Contrasting Health Canada and internal academic audit mechanisms and outcomes. SoCRA Source Journal, 66, 26-31. 2.Austin, DM. (2010, November). Investigational product accountability to ensure audit readiness. SoCRA Source Journal, 66, 42-46. 3.Korieth, K. (2011, February). The high cost and questionable impact of 100% SDV: Sponsors, CROs reluctant to alter standard practice. The CenterWatch Monthly, 18(2), pp.1, 15-17.

11. Answer the questions in Section II (page 2) of your handout to assess the risks inherent in your research group.

12. Where and When is it Audited? Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored Audits Fall in the Middle of the Continuing Review Cycle (±2 Months)

14. Where and When is it Audited? Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored Audits Fall in the Middle of the Continuing Review Cycle (±2 Months) The Auditor Provides Written Notification to the PI and Lead Study Coordinator Approximately Two Weeks in Advance

15. The Email Notification RE:Internal Audit of Study No. [IRB No.] Dear Dr. [Name]: This email is to remind you that the above-referenced study is scheduled to be audited on [Date]; I will be reviewing the records for all subjects enrolled since the last continuing review approval (Date). I will coordinate the audit with the primary research coordinator on this study, [Name], and will disseminate the findings to the team afterward. Attached to this email are three documents for your reference: A copy of the internal audit template that will be used to direct the audit proceedings; a copy of the General Surgery internal auditing SOP; and a copy of the General Surgery Research Compliance Tip Sheet. If you have any questions about protocol compliance, please feel free to contact me at your convenience. CC:[Research Coordinator]

16. Where and When is it Audited? Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored Audits Fall in the Middle of the Continuing Review Cycle (±2 Months) The Auditor Provides Written Notification to the PI and Lead Study Coordinator Approximately Two Weeks in Advance Audits are Scheduled Using Outlook (Appearing on the Research Staff’s Calendar) The PI and Research Staff are Not Present During the Audit The Audit Findings are Disseminated in Writing to the PI, Research Staff, and Regulatory Staff Following the Internal Audit

17. Answer the questions in Section III (page 2) of your handout to consider the auditing logistics appropriate for your research group.

18. How is it Audited? Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP

19. How is it Audited? Proper ICS Version and Pagination Proper IRB Approval Stamp(s) on ICS Proper ICS Execution Informed Consent Process Note Review Proper HIPAA Authorization Version and Pagination Proper IRB Approval Stamp on HIPAA Authorization Proper HIPAA Authorization Execution Medical Records Documentation (VA Only)

20. How is it Audited? Informed Consent Documents and Informed Consent Process Documentation HIPAA Authorizations Subject Eligibility Protocol Compliance (Deviations and Violations) Subject Safety Compliance with the DSMP

21. How is it Audited? Subject Eligibility – Eligibility Checklist Review and Source Document Verification (Sampling) Protocol Compliance – eCRF Review and Source Document Verification (Sampling)

22. The Compliance Log

23. How is it Audited? Subject Eligibility – Eligibility Checklist Review and Source Document Verification (Sampling) Protocol Compliance – eCRF Review and Source Document Verification (Sampling) Subject Safety – Regulatory File Review – eCRF Review and Source Document Verification (Sampling)

24. The Safety Log

25. How is it Audited? Subject Eligibility – Eligibility Checklist Review and Source Document Verification (Sampling) Protocol Compliance – eCRF Review and Source Document Verification (Sampling) Subject Safety – eCRF Review and Source Document Verification (Sampling) – Regulatory File Review DSMP Compliance – Regulatory File Review

26. Answer the questions in Section IV (page 2) of your handout to consider the internal auditing priorities for your research group.

27. The Coordinator’s Perspective 1.“An ounce of prevention is worth a pound of cure.”

28. Answer Question 1 in Section V (page 3) of your handout to brainstorm some “preventative actions” for your research practice.

29. The Coordinator’s Perspective 1.“An ounce of prevention is worth a pound of cure.” 2.Leave a trail of “bread crumbs” for the next person.

30. Answer Question 2 in Section V (page 3) of your handout to assess how detailed, organized, and reliable you are in your research practice.

31. The Coordinator’s Perspective 1.“An ounce of prevention is worth a pound of cure.” 2.Leave a trail of “bread crumbs” for the next person. 3.Prep for the “big day”.

32. The Coordinator’s Perspective 1.“An ounce of prevention is worth a pound of cure.” 2.Leave a trail of “bread crumbs” for the next person. 3.Prep for the “big day”. 4.Turn that frown upside down.

33. Answer Question 3 in Section V (page 3) of your handout to identify opportunities to promote internal auditing.