Responding to your audit workshop Nov 2008 v2

Ckcolligan

Sujets

• managers

Informations

• Publié par: Lalip
• Nombre de lectures: 46
• Langue: English

Extrait

Preparing your Audit
Response: Communication
with the Central Office
Barbara Barrett, Audit Program Manager
Crystal Newkirk, Audit Coordinator
CALGB Central Office
CALGB Audit Prep Workshop, November 2008
For CALGB Participants Only
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 the Central Office.
The Audit Program Manager (APM) reviews
the draft, resolves any outstanding issues,
and makes any necessary changes.
For CALGB Participants Only Slide 4After the Audit:
Central Office Review
• Day 70 (or sooner): The Audit Coordinator
(AC) submits the final version of the report to
the CTMB via the AIS electronic database.
• Day 70 (or sooner): Final audit report is sent
via CALGB secure mail to the main member’s
Principal Investigator and Lead CRA
For CALGB Participants Only Slide 5
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!
For CALGB Participants Only Slide 6• If you have any difficulty accessing your audit
report through CALGB Secure Mail System,
please contact the CALGB Help Desk at 1-877-
44-CALGB (442-2542)
For CALGB Participants Only Slide 8If you’ve received an IRB
Unacceptable…
• If the IRB/ICC CAP 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.
For CALGB Participants Only Slide 9
Sample Audit ReportsFor CALGB Participants Only Slide 11Submission of CAPs
• 30 days after audit report distribution: The
complete corrective action plan (CAP) must be
submitted to the Central Office.
• The APM reviews the corrective action plan to
determine if the response is Acceptable. If the
CAP is not Acceptable, clarification of
additional information will be requested.
• 30-45 days after the audit report distribution:
The APM will submit the CAP to CTMB.
• If the CTMB requires additional information,
they will contact the AC & APM. CALGB does
not receive notification of acceptance of CAPs.
For CALGB Participants Only Slide 13
Submission of CAPs
• If a corrective action plan has not been received
in the CO by 30 days, the Audit Coordinator
will provide written notice to the PI that an
institution’s CAP is overdue and a five day grace
period will be granted for its submission.
• If a CAP is not submitted within the grace
period all new patient registration will be
suspended for the entire member network.
• Patient registration for the entire network will
not be permitted to resume until a CAP has
been approved by the APM then forwarded and
reviewed by the CTMB.
For CALGB Participants Only Slide 14Submission of CAPs
• Author(s) of CAP should be identified. CAP
MUST be submitted on letterhead and signed
by the PI, the local RI (when appropriate), and
any other author.
• Please address CAP questions to AC and APM
before the due date.
• Attach required support documentation.
• Submit CAPs via email to save $
For CALGB Participants Only Slide 15
Writing a Satisfactory CAP
• Address each deficiency or each type of
deficiency individually.
• 3 questions must be addressed for each
deficiency:
– Why did this deficiency occur? What was
the problem?
– Has the specific problem been corrected
(i.e. has the outstanding data in question been
submitted? Has the patient been re-consented with
the updated consent form?)
– What plan has been implemented to ensure
this type of deficiency will not occur in the
future?
For CALGB Participants Only Slide 16Samples of Acceptable/Unacceptable
Corrective Action Plans
For CALGB Participants Only Slide 17
For CALGB Participants Only Slide 18• The corrective action provided here is Acceptable;
however, it is helpful to report that this institution has
submitted the outstanding broadcast ESAEs
For CALGB Participants Only Slide 19
• CAPs require much more than agreement or
disagreement with the auditors’ assessment: Why was
there an unjustified dose modification? What plan is
now in place to prevent this deficiency from occurring
again? Have policies and procedures been revised or
developed to address the deficiency? Submit revised
policies!
For CALGB Participants Only Slide 20