How to Ace an AuditRandom Review

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How to Ace an AuditRandom Review

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How to Ace an Audit/Random Review. Roxanne M. Pritchard, RN, BSN, CIP. Quality Assurance & Audit ... Provide feedback to investigators, research team members, ... – PowerPoint PPT presentation

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Title: 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

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