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    Internal Auditing In Research Internal Auditing In Research Presentation Transcript

    • Internal Auditing in Research:The QA ProcessResearch Education SeriesFebruary 14, 2011
      Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist
      Heather Kemp, MBA, CCRP, Clinical Research Coordinator
      Department of Surgery, General Surgery Section
    • 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
    • The Research Context
    • The Research Context
    • Now It’s Your Turn
      Answer the questions in Section I (page 1) of your handout to assess the context of your research group.
    • Why is it Audited?
      Compliance
      Process Improvement
      Education
    • 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.
    • 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
    • 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
      Expedited
    • Other Resources
      Toward, J. (2010, November). Contrasting Health Canada and internal academic audit mechanisms and outcomes. SoCRA Source Journal, 66, 26-31.
      Austin, DM. (2010, November). Investigational product accountability to ensure audit readiness. SoCRA Source Journal, 66, 42-46.
      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.
    • Now It’s Your Turn
      Answer the questions in Section II (page 2) of your handout to assess the risks inherent in your research group.
    • 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)
    • 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
    • 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]
    • 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
    • Now It’s Your Turn
      Answer the questions in Section III (page 2) of your handout to consider the auditing logistics appropriate for your research group.
    • 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
    • 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)
    • 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
    • How is it Audited?
      Subject Eligibility
      Eligibility Checklist Review and Source Document Verification (Sampling)
      Protocol Compliance
      eCRF Review and Source Document Verification (Sampling)
    • The Compliance Log
    • 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)
    • The Safety Log
    • 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
    • Now It’s Your Turn
      Answer the questions in Section IV (page 2) of your handout to consider the internal auditing priorities for your research group.
    • The Coordinator’s Perspective
      “An ounce of prevention is worth a pound of cure.”
    • Now It’s Your Turn
      Answer Question 1 in Section V (page 3) of your handout to brainstorm some “preventative actions” for your research practice.
    • The Coordinator’s Perspective
      “An ounce of prevention is worth a pound of cure.”
      Leave a trail of “bread crumbs” for the next person.
    • Now It’s Your Turn
      Answer Question 2 in Section V (page 3) of your handout to assess how detailed, organized, and reliable you are in your research practice.
    • The Coordinator’s Perspective
      “An ounce of prevention is worth a pound of cure.”
      Leave a trail of “bread crumbs” for the next person.
      Prep for the “big day”.
    • The Coordinator’s Perspective
      “An ounce of prevention is worth a pound of cure.”
      Leave a trail of “bread crumbs” for the next person.
      Prep for the “big day”.
      Turn that frown upside down.
    • Now It’s Your Turn
      Answer Question 3 in Section V (page 3) of your handout to identify opportunities to promote internal auditing.