Internal Auditing In Research

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Internal Auditing In Research

  1. 1. Internal Auditing in Research:The QA ProcessResearch Education SeriesFebruary 14, 2011<br />Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist<br />Heather Kemp, MBA, CCRP, Clinical Research Coordinator<br />Department of Surgery, General Surgery Section<br />
  2. 2. Agenda / Overview<br />Assessing Risk in Auditing<br />The SOP: Answering the Who, What, Where, When, Why, and How of Internal Auditing<br />The Coordinator’s Perspective: Before, During, and After an Internal Audit<br />
  3. 3. The Research Context<br />
  4. 4. The Research Context<br />
  5. 5. Now It’s Your Turn<br />Answer the questions in Section I (page 1) of your handout to assess the context of your research group.<br />
  6. 6. Why is it Audited?<br />Compliance<br />Process Improvement<br />Education<br />
  7. 7. Who is Audited?<br />All research which:<br />Is not exempt from IRB review;<br />Is not being conducted under a waiver of informed consent;<br />Has subjects enrolled on the study; and<br />Has not been reviewed by the Clinical Trials Monitoring Committee in the past 12 months.<br />
  8. 8. What is Audited?<br />Informed Consent Documents and Informed Consent Process Documentation<br />HIPAA Authorizations<br />Subject Eligibility<br />Protocol Compliance (Deviations and Violations)<br />Subject Safety<br />Compliance with the DSMP<br />
  9. 9. Sponsored Trials: Exceptions to the Rule<br />Informed Consent Documents and Informed Consent Process Documentation<br />HIPAA Authorizations<br />Subject Eligibility<br />Protocol Compliance (Deviations and Violations)<br />Subject Safety<br />Compliance with the DSMP<br />Expedited<br />
  10. 10. Other Resources<br />Toward, J. (2010, November). Contrasting Health Canada and internal academic audit mechanisms and outcomes. SoCRA Source Journal, 66, 26-31.<br />Austin, DM. (2010, November). Investigational product accountability to ensure audit readiness. SoCRA Source Journal, 66, 42-46.<br />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.<br />
  11. 11. Now It’s Your Turn<br />Answer the questions in Section II (page 2) of your handout to assess the risks inherent in your research group.<br />
  12. 12. Where and When is it Audited?<br />Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored<br />Audits Fall in the Middle of the Continuing Review Cycle (±2 Months)<br />
  13. 13.
  14. 14. Where and When is it Audited?<br />Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored<br />Audits Fall in the Middle of the Continuing Review Cycle (±2 Months)<br />The Auditor Provides Written Notification to the PI and Lead Study Coordinator Approximately Two Weeks in Advance<br />
  15. 15. The Email Notification<br />RE: Internal Audit of Study No. [IRB No.]<br /> <br />Dear Dr. [Name]:<br /> <br />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.<br /> <br />Attached to this email are three documents for your reference:<br />A copy of the internal audit template that will be used to direct the audit proceedings;<br />a copy of the General Surgery internal auditing SOP; and<br />a copy of the General Surgery Research Compliance Tip Sheet.<br />If you have any questions about protocol compliance, please feel free to contact me at your convenience.<br /> <br />CC: [Research Coordinator]<br />
  16. 16. Where and When is it Audited?<br />Audits are Conducted in the Office/Clinic/Lab Where Study Charts are Stored<br />Audits Fall in the Middle of the Continuing Review Cycle (±2 Months)<br />The Auditor Provides Written Notification to the PI and Lead Study Coordinator Approximately Two Weeks in Advance<br />Audits are Scheduled Using Outlook (Appearing on the Research Staff’s Calendar)<br />The PI and Research Staff are Not Present During the Audit<br />The Audit Findings are Disseminated in Writing to the PI, Research Staff, and Regulatory Staff Following the Internal Audit<br />
  17. 17. Now It’s Your Turn<br />Answer the questions in Section III (page 2) of your handout to consider the auditing logistics appropriate for your research group.<br />
  18. 18. How is it Audited?<br />Informed Consent Documents and Informed Consent Process Documentation<br />HIPAA Authorizations<br />Subject Eligibility<br />Protocol Compliance (Deviations and Violations)<br />Subject Safety<br />Compliance with the DSMP<br />
  19. 19. How is it Audited?<br />Proper ICS Version and Pagination<br />Proper IRB Approval Stamp(s) on ICS<br />Proper ICS Execution<br />Informed Consent Process Note Review<br />Proper HIPAA Authorization Version and Pagination<br />Proper IRB Approval Stamp on HIPAA Authorization<br />Proper HIPAA Authorization Execution<br />Medical Records Documentation (VA Only)<br />
  20. 20. How is it Audited?<br />Informed Consent Documents and Informed Consent Process Documentation<br />HIPAA Authorizations<br />Subject Eligibility<br />Protocol Compliance (Deviations and Violations)<br />Subject Safety<br />Compliance with the DSMP<br />
  21. 21. How is it Audited?<br />Subject Eligibility<br />Eligibility Checklist Review and Source Document Verification (Sampling)<br />Protocol Compliance<br />eCRF Review and Source Document Verification (Sampling)<br />
  22. 22. The Compliance Log<br />
  23. 23. How is it Audited?<br />Subject Eligibility<br />Eligibility Checklist Review and Source Document Verification (Sampling)<br />Protocol Compliance<br />eCRF Review and Source Document Verification (Sampling)<br />Subject Safety<br />Regulatory File Review<br />eCRF Review and Source Document Verification (Sampling)<br />
  24. 24. The Safety Log<br />
  25. 25. How is it Audited?<br />Subject Eligibility<br />Eligibility Checklist Review and Source Document Verification (Sampling)<br />Protocol Compliance<br />eCRF Review and Source Document Verification (Sampling)<br />Subject Safety<br />eCRF Review and Source Document Verification (Sampling)<br />Regulatory File Review<br />DSMP Compliance<br />Regulatory File Review<br />
  26. 26. Now It’s Your Turn<br />Answer the questions in Section IV (page 2) of your handout to consider the internal auditing priorities for your research group.<br />
  27. 27. The Coordinator’s Perspective<br />“An ounce of prevention is worth a pound of cure.”<br />
  28. 28. Now It’s Your Turn<br />Answer Question 1 in Section V (page 3) of your handout to brainstorm some “preventative actions” for your research practice.<br />
  29. 29. The Coordinator’s Perspective<br />“An ounce of prevention is worth a pound of cure.”<br />Leave a trail of “bread crumbs” for the next person.<br />
  30. 30. Now It’s Your Turn<br />Answer Question 2 in Section V (page 3) of your handout to assess how detailed, organized, and reliable you are in your research practice.<br />
  31. 31. The Coordinator’s Perspective<br />“An ounce of prevention is worth a pound of cure.”<br />Leave a trail of “bread crumbs” for the next person.<br />Prep for the “big day”.<br />
  32. 32. The Coordinator’s Perspective<br />“An ounce of prevention is worth a pound of cure.”<br />Leave a trail of “bread crumbs” for the next person.<br />Prep for the “big day”.<br />Turn that frown upside down.<br />
  33. 33. Now It’s Your Turn<br />Answer Question 3 in Section V (page 3) of your handout to identify opportunities to promote internal auditing.<br />

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