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Research Compliance Audits How It All Works

Research Compliance Audits How It All Works. Demetra M. Lewis, MPH Research Compliance Lead Analyst UMMC - Office of Integrity and Compliance. Office of Integrity & Compliance.

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Research Compliance Audits How It All Works

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  1. Research Compliance AuditsHow It All Works Demetra M. Lewis, MPH Research Compliance Lead Analyst UMMC - Office of Integrity and Compliance

  2. Office of Integrity & Compliance • Compliance program to develop effective internal controls that promote adherence to applicable federal and state laws/regulations, and the program requirements of federal, state and private health plans.

  3. Compliance Subcommittees The Institutional Compliance Committee has delegated limited authority to the following subcommittees to carry out compliance activities · Hospital Compliance Subcommittee · Physician Compliance Subcommittee · Research Compliance Subcommittee · HIPAA Subcommittee

  4. Research Compliance • UMMC research activities are monitored to ensure compliance with federal, state and institutional regulations. This is accomplished by the regular auditing of such activities as: • IRB /IACUC record keeping; research billing; and documentation of investigational drug administration • Addressing unique research issues as they arise, and interpreting, developing and implementing policies and procedures related to research.  

  5. Research Compliance • Reviews are conducted • to assess the investigator’s compliance, • to identify areas for improvement, • To provide guidance and recommendations based on existing regulations, policies and procedures.

  6. Annual Monitoring Plan • The Research Compliance Monitoring Plan is posted on the OIC’s webpage. • OIG Work Plan (Office of the Inspector General) • Research Compliance Subcommittee Input • High Risk Areas Identified • Past Issues Identified

  7. Research Compliance Perform audits of research areas that include: • Human & Animal research studies • Regulatory & Study Documents • Clinical research billing • Billing Form & Associated Charges • Investigational drug studies • Documented on the MAR

  8. Research Compliance Perform audits of research areas that include: • Controlled substances in research - Recordkeeping? DEA? MBOP? • ClinicalTrials.gov Registration / Reporting • Applicable? Required Statement? • IRB Requested Audits • Review of research guidelines, policies and procedures.

  9. Selection of cases for audit • Random selection (RATS-STATS program) • IRB requested audits • Hotline calls • Reports of compliance concerns

  10. Preparing for an Audit Long before the audit: • Create and maintain internal controls over the activity • Conduct self-audits *HANDOUT - Investigator Record Review Self-Assessment Checklist

  11. Preparing for an Audit During an audit: (Examples) • Study records/files should be readily available • IRB Communications/IDEATE • List of participants enrolled with dates • Study Data Collected • Specimen Samples *HANDOUT - Record Review Audit Documentation Checklist

  12. Notice of Findings / CAPs • When the audit has been completed, the responsible party (usually PI and SC) will receive results of the audit. • The report will contain recommendations or required actions on how to correct any findings. • If necessary, a corrective action plan will be requested to present to the Research Compliance Subcommittee. Department Chairs are notified when CAPs are requested.

  13. CAPs / CAPAs - Corrective Action (Preventive) Plans • Tell us how you will correct the errors that were identified • Include dates for implementation of any corrective action • How will you prevent this from happening in the future? • Provide dates of in-service trainings, etc.

  14. CAPs / CAPAs - Corrective Action (Preventive) Plans The best written CAP is said to S.M.A.R.T. • Specific – what area(s) do you want to improve • Measurable – how will you know its accomplished • Actionable – who will be responsible • Realistic - what result(s) can realistically be achieved • Time - when the result(s) can be achieved

  15. Re-audits All studies requiring a corrective action plan will be re-audited to determine if proposed actions were completed and effective.

  16. Past Audit Findings • Protocol Deviations • Consent / Parental & Assent Documents issues - Missing/Incomplete Signatures & Dates - Not in medical records • Outside Data Collection / Generation Period • Over Enrolled Subjects • DUA not on file/not fully executed

  17. PastAudit Findings • Data Collected is Not Secured • Not password protected • Who has access? The whole department?!?!?!?! • Study Personnel Not Approved for Study Activities • Obtain Consent, Medical Records, Administrative • All personnel obtaining consent are not listed in the IRB application and have not received training • Information in IDEATE is not accurate & updated

  18. An Auditor’s Perspective • Study Documentation • How & When It’s Documented Matters • Tells or Doesn’t Tell the Story

  19. An Auditor’s Perspective • Documentation is how auditors and inspectors determine how the study was conducted • Help us just turn the pages • Accurate, complete documentation of all aspects of the study illustrates regulatory and protocol compliance: • Subject records, IRB records, Drug or device accountability, informed consent, AE / SAE reporting, correspondences

  20. We are on the same team!

  21. Contact Information • Demetra Lewis, MPH dmlewi@umc.edu • Research Compliance Lead Analyst • Ext. 5-5076 • Xavier Johnson, MPH xjohnson@umc.edu • Research Compliance Analyst II • Ext. 5-3594

  22. Questions?

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