Audit Repsonse with Central Office

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Publié par	Thaub
Nombre de lectures	18
Langue	English

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Preparing your
Audit Response Communication
with the Central Office
Sally Scherer, Audit Specialist
CALGB Central Office
CALGB Audit Prep Workshop, June 2006
Preparing Your Audit Response:
Communication with the Central
OfficePost-Audit Timeline
After the Audit:
Central Office Review
• Day 0: Audit takes place.
• Day 1-70: Team Leader drafts audit report
and submits the draft to DAC Chair. The
DAC Chair reviews the draft, resolves any
outstanding issues, and makes any
necessary changes. The DAC Chair then
submits the report to the Central Office.After the Audit:
Central Office Review
• The Audit Specialist and Group
Administrator review the audit report draft
and resolve any outstanding questions in
collaboration with the DAC Chair and the
Audit Team Leader. The final version of
the report is submitted to the CTMB via the
AIS electronic database.
After the Audit:
Central Office Review
• Day 70 (or sooner): Final audit report is sent via
fed-ex to the main member’s Principal
Investigator.
• Electronic copies are also sent to:
– the main member’s PI
– Lead CRA
– the affiliate’s Local Responsible InvestigatorAfter the Audit: Day 1-30
• Institution staff should meet to discuss and review
the specific deficiencies identified at the audit and
draft an outline of a corrective action plan.
• Email the Team Leader with any additional
questions or for further clarification on specific
deficiencies.
• Respond promptly to inquiries from Team Leader
or DAC Chair.
• Contact Audit Specialist with questions about the
audit report process.
After the Audit: Day 1-30
Unacceptable IRB/ICC Rating
• If the auditors indicate that your institution will
receive an Unacceptable rating in the IRB/ICC
segment in the final audit report, institution staff
should meet to review and discuss specific
deficiencies identified in the IRB/ICC segment.
• Consider your plan of corrective action and
prepare a preliminary response for this segment to
avoid possible suspension of patient accrual. Staff
should draft and be ready to submit a final
response upon receipt of the audit report. Audit Report Distribution
• It is the main member’s responsibility
to promptly send the audit report to its
affiliate!
• Communication between main member
and affiliate is key!
If you’ve received an IRB
Unacceptable…
• 1 Day after audit report distribution: If an
institution receives an Unacceptable rating for the
IRB/ICC segment of their audit, a response to this
section is due by 5 p.m. on the next business day,
after the report is sent by email to the PI, Lead
CRA, and RI.
• If this response is not submitted and found
Acceptable at that time, patient accrual at the
institution will suspended.
• This suspension will be lifted when a response is
submitted and found to be Acceptable.Sample Audit Reports and
Cover LettersAfter the Audit:
Central Office Review
• 4 weeks after audit report distribution: The
complete corrective action plan (CAP) must be
submitted to the Central Office.
• 4-6 weeks after the audit report distribution: The
Audit Specialist reviews the corrective action plan
to determine if the response is Acceptable. If the
CAP is not Acceptable, the Audit Specialist will
communicate with the PI, the Lead CRA, local
RIs, and any other authors of the response to
obtain additional information.1-4 weeks after Audit Report Distribution
• 4 weeks after audit report distribution: The complete
corrective action plan (CAP) must be submitted to the
Central Office. Finalize CAP and submit to Central Office
by due date.
• Author(s) of CAP should be identified. CAP MUST be
reviewed and signed by each of its authors, the local RI,
and the main member PI.
• If CAP is not submitted by due date, patient accrual will be
suspended!
• Please address CAP questions to Audit Specialist before
the due date.
• Submit required support documentation.
Review and Submission of CAP
• 4-6 weeks after the audit report distribution: The
Audit Specialist and Group Administrator review
the corrective action plan to determine if the
response is Acceptable. If the CAP is not
Acceptable, the Audit Specialist will communicate
with the PI, the Lead CRA, local RIs, and any
other authors of the response to obtain additional
information.
• The Audit Specialist submits the institution’s
corrective action plan to the CTMB along with an
assessment of its adequacy.

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