How to Ace an AuditRandom Review

1
How to Ace an Audit/Random Review

• Roxanne M. Pritchard, RN, BSN, CIP
• Quality Assurance Audit
• Office of Research
• March 27, 2007

2
Quality Assurance Audit

• Focus the conduct of research involving human
  subjects.
• Identify and promote standards of good clinical
  practices in the conduct of research.
• Provide feedback to investigators, research team
  members, MCW/FH IRBs and other MCW/FH parties
  regarding the conduct of research

3
Quality Assurance Audit webpage
4
What is an Audit?

• Systematic process involving the examination of
  information
• Comparison of reviewed information to the
  standard (protocol, regulatory requirements,
  investigator agreement)
• Review and report of aggregate findings

5
Audit Versus Review at MCW

• An audit is conducted for a specific reason
• Notification of audit findings
• Distribution of report of findings
• May result in the IRB requiring a corrective
  action plan
• May result in re-audit
• The Institutional Official must notify federal
  agencies and affiliated institutions of certain
  findings and actions taken

6
How to be in the best prepared state for an audit

• Know your study
• Know the applicable regulations policies and
  standards
• Know the roles and responsibilities of each
  member of the study team

7
How to be in the best prepared state for an audit

• Create a plan regarding the compliant conduct of
  the study
• Create and use tools such as guidelines and
  checklists to identify required study activities
  and items to include in regulatory or study
  participant files
• Create and use tracking systems
  (screening/enrollment, study visits)
• Create and maintain a study regulatory file
• Create and maintain study participant files

8
How to be in the best prepared state for an audit

• Review and discuss the plan for the conduct of
  the study before initiation of the study
  activities and on an ongoing basis
• Ensure effective, accurate and current
  communication among all members of the research
  team
• Provide training as needed
• Implement quality assurance activities to ensure
  the study related activities and documentation
  are in accordance with your plan.
• Activities must be easy to maintain
• Activities should be accomplished in short period
  of time

9
How to be in the best prepared state for an audit

• Document, document, document
• Attend a workshop on audit preparation

10
What to do when you learn of an upcoming audit

• Confirm the date and time of the audit
• Obtain information regarding
• purpose of audit
• composition of audit team
• anticipated duration of audit

11
What to do when you learn of an upcoming audit

• Notify principal investigator
• Notify research team members
• Notify IRB office
• Notify QA Audit office

12
What to do when you learn of an upcoming audit

• Ensure and confirm all documentation and other
  research records are available for review and are
  in order
• If the study involves electronically captured
  documentation check with your institution
  regarding its policy for review of this
  documentation by external personnel

13
What to do when you learn of an upcoming audit

• Ensure key personnel are available during the
  audit to meet with the auditor(s) and address
  audit related issues/concerns.
• Secure an appropriate space for the auditor(s)
• Ensure the availability of equipment for auditor
  (phone, FAX, data port, reader box)

14
What to do when you learn of an upcoming audit

• In the event of a federal agency audit
• Notify the study sponsor (in addition to the
  previously described activities)

15
What to do during an audit

• Verify the auditor's credentials
• In the case of a federal audit ask to see the
  Notice to Inspect document(s)
• Identify the key point person and ensure the
  availability of that person to address any
  questions/concerns or provide requested
  materials/information
• Provide adequate space for the auditor(s)
• Ensure the availability of equipment for auditor

16
What to do during an audit

• Answer all questions honestly. If you dont know
  the answer indicate you will obtain the answer
  and provide the information to the auditor
• Provide all requested materials for auditor's
  review
• Make copies for auditor (upon auditors request)
• Include a copy of anything provided to the
  auditor for your file

17
What not to do during an audit

• Do not allow auditor to retrieve
  documents/materials on his/her own
• Do not volunteer information
• Do not offer anything of significant value to the
  auditor

18
What to do upon completion of the audit

• Attend the debriefing meeting
• Review the findings of the audit
• Submit written response
• Implement corrective actions
• Include information about the audit in your
  upcoming continuing progress report to the IRB

19
10 Common Findings of Noncompliance

• Source documentation inadequate, incomplete, not
  available
• All versions of protocol and Investigator
  Brochure not on file
• Investigational product accountability
  incomplete, has discrepancies
• Ineligible individuals enrolled onto study
• Current IRB approve consent form not used
• Consenting process not documented
• IRB, sponsor not informed of reportable events in
  timely manner
• Regulatory binders incomplete
• Recorded research data not verified by source
  documentation
• Study not conducted in accordance with IRB
  approved protocol and regulatory requirements

20
For more information

• Quality Assurance Audit website
• http//www.mcw.edu/display/router.asp?docid20439
• IRB Action Guidelines
• http//www.mcw.edu/display/router.asp?docid13124
• Dean, T. Beth RN, CCRC, Fowler, Donna R. RN, BSN,
  CCRC and Thomas , Carolynn J. RN, BSN, MSPH.
  2003. Quality Time The Art of QA Program
  Development for Research Sites. Research
  Practitioner volume 4 Number 6 219-224