Internal Audits And How They Can Help You Really

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Internal Audits And How They Can Help
You(Really!)

• Karen Barnwell
• Auditor
• UAMS Office of Research Compliance

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Oh no! Not the auditors!!!
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What IS an audit, anyway?

• Formal definitions
• An assessment of study-related processes,
  procedures, and documentation review
• A review to verify the accuracy and reliability
  of study data

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Goals of An Internal Audit

• To verify that the safety of human subjects is
  protected and that risks to them are minimized
• To ensure that institutional policies and
  procedures and applicable regulations are being
  followed
• To make sure your data are usable

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The Take-Home Message About Internal Audits

• They are NOT intended to be punitive.
• They ARE intended to be educational.
• The things you learn from an audit will help you
  to strengthen ALL of your studies.

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The types of audits we do

• UAMS, VA, ACH
• Targeted Review
• For Cause or Directed
• Routine
• Preparatory Review
• Requested Audit

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Targeted Review

• Trouble-shooting in a specific area
• Gather data to render an opinion on specific
  study practices
• Assess need for follow-up

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For Cause

• A possible problem has been identified and deemed
  credible.
• ALL aspects of the study are typically reviewed.
• Look at adherence to institutional policies and
  procedures, regulations, and human subject
  protection requirements.

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Routine Audits

• Get a picture of the overall state of research
• Adequate protection of subjects institutional
  policies and procedures regulations
• Suggest ways to improve research
• Helps new studies get off to a good start

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Preparatory Review

• Assistance/Assurance Audit
• Requested by study personnel being audited by an
  external agency

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Requested Review

• Requested by the PI or study staff
• Can be limited in scope or a full review
• Full IRB review studies only

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How we go about it

• Telephone call and/or letter and/or email

• Audit type
• Which study
• Possible dates
• Documents we expect to review
• Subject enrollment log

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Further preparation

• We will review the IRBs records of the study
• Well confirm the dates and give you a list of
  the records well need, including subject records

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What we need

• The documents plus access to any electronic
  databases
• An out-of-the-way secure area with electrical
  outlets and, preferably, internet access
• Sufficient room to work
• Telephone numbers for key personnel
• Access to a photocopier

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The Audit Begins

• Meet with PI and/or study coordinator and/or
  study staff
• Show us any relevant facilities
• Walk us through the records

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The Audit Itself

• One to three days are typically scheduled.
• We will work with the records and protect their
  confidentiality.
• We ask that study staff be available to answer
  any questions or provide additional records.

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The Audit Ends

• Brief discussion about any general themes that
  emerged from the audit
• We will give you much more detail at the time we
  deliver the Audit Report.

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Audit Report

• Aim to have it done no more than 3 weeks after
  the audit.
• Well present it in person.
• Includes findings.
• Yes, you can respond to it.
• Leave one paper copy more if PI says its OK.

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Your Report Response

• When can we expect one from you?
• Elaborate on remediation of findings
• Refute findings when appropriate
• Attach relevant documents

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Final Report

• Includes audit report, PIs response, cover
  letter
• Includes status of remediation efforts
• Copies to IRB, Institutional Compliance Office
  (as appropriate), VCAA/RA, ORC file

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Reports for Preparatory Reviews

• Get report done ASAP (can be very informal)
• Suggest things to fix before the external
  auditors arrive
• Point out areas that perhaps cant be fixed, but
  you can be prepared to address with the external
  auditors

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So, how does this help me?

• Help find strengths that can be applied to other
  studies
• Identify any problems early, when fixing them is
  relatively easy
• What you learn in a particular audit can be
  applied to many studies

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What else can ORC do for me?

• Answer questions about audits, regulations, and
  just about anything else related to human subject
  research
• Education programs
• Self-assessment tools
• Call us 526-6876
• Check out our web site www.uams.edu/orc/