Preparing Your Audit Response: Corrective And Preventative .
Preparing Your Audit Response:Corrective and Preventative Action Plans(CAPAs)Barbara Barrett, Audit Program DirectorAlliance Chicago OfficeAlliance Fall 2014 Group Meeting
CAPAs and Good ClinicalPracticeGoals of CAPAs:l Assess to measurel Measure to correctl Correct to preventl Prevent to achievel [SoCRA SOURCE – August 2012]
CAPAs and Good ClinicalPracticePreventing errors in the future:1) Eliminates potential patient safety issues2) Provides cleaner research data3) Saves time for staff and lead group4) Ultimately reduces costs
Audit Exit InterviewReminders Take notes throughout the audit and at the ExitInterviewMake sure to understand the comments from theExit Interview - don’t be afraid to ask questions
The Final Audit Report(behind the scenes) Team Leader creates a draft audit report andresolves any outstanding issues with the siteA second review is conducted to check foraccuracy and consistency between sites
The Final Report(behind the scenes) The final version is submitted in the CTMB viathe AIS (Audit Information System) electronicdatabaseAn electronic version of the final audit report isemailed to the Principal Investigator and LeadCRA - plus hard copies are sent Fed Ex.
Audit Report Distribution toAffiliates and Components It is the Main Member’s or NCORP’sresponsibility to review the audit report withaffiliate(s)/components
Understanding the Audit ReportReminder of three audit components: IRB/ Consent Content Pharmacy Patient Case Review
Understanding the Audit ReportCategory ratings: OK (no deficiency is warranted)Lesser Deficiency (minor deficiency)Major Deficiency (significant error or omission)
Understanding the Audit ReportOverall Category Assessment: Acceptable – No follow-up is needed Acceptable Needs Follow-up – corrective andpreventative action plan required within 15 businessdays Unacceptable – As above and re-audit scheduledwithin 12 months required
If you received an Unacceptablerating Alliance Policy - An Unacceptable rating in anysection of the audit is evaluated on a case-bycase basis and may warrant immediatesuspension of registration privileges Should a suspension occur, it will be lifted whena response is submitted and found to beAcceptable
Sample Audit Reports
Audit Report Cover Letter Summarizes the three ratings:The IRB/Consent Content review was ratedAcceptable Needs Follow-up. The deficienciesincludes . Pharmacy review was ratedAcceptable. The Patient Case review was ratedUnacceptable. The deficiencies include . Provides a date the CAPA is due:A written corrective and preventative action planaddressing the deficiencies in these areas must besubmitted by Tuesday, December 16, 2014.
Submission of CAPAsCAPAs must include:- Corrective measures taken for deficiencies (e.g.,submission of outstanding data, correction andsubmission of data errors, or IRB submission ofmissed protocol updates)- Measures for prevention of deficiencies in thefuture, e.g. revision of your P&Ps, additionaltraining, discussion with IRB regarding proceduresand timelines, re-education of staff involved- ***Happy to review draft CAPAs***
Submission of CAPAs Author(s) of CAPA should be identifiedCAPA MUST be submitted on letterhead and signedby the PI, plus any other author(s)Attach any pertinent support documentation (submitamended CRFs to the data center)No need to attach copy of your audit reportSubmit CAPAs via email or fax, following up withoriginals
CAPA Review The audit program director (APD) reviews thecorrective and preventative action plan todetermine if the response is Acceptable. If theCAPA is not Acceptable, clarification ofadditional information will be requested. The CAPA will be submitted to the CTMB If the CTMB requires additional information, theywill contact the Alliance
Writing a Satisfactory CAPA Address each issue listed in audit report asneeding follow-up. Address 3 questions:l Why did this deficiency occur? (i.e, what was theproblem?)l Has the specific problem been corrected? (i.e. has theoutstanding data in question been submitted? Has thepatient been re-consented with the updated consent form?)l What plan has been implemented to ensure this type ofdeficiency will not occur in the future?
Samples of Acceptable/Unacceptable Corrective ActionPlans
IRB DeficiencyMajor DeficiencyUpdate #6 posted on02/15/14 has not beensubmitted to the IRB.Partially AcceptableCAPAAs updates are identified,they will be entered on theOutlook calendar tosubmit and track.
IRB Consent Content DeficiencyMajor DeficiencyPartially AcceptableCAPAThe local ICF does notinclude samplesubmission question #1from page 2 of the modelconsent. This study is stillopen to new enrollment.A revision has beensubmitted to the IRB thatincludes all modelconsent questions. Thesite will now use theconsent content checklistand review local consentscompared to modelconsents.
Pharmacy DeficiencyMajor DeficiencyAcceptable orUnacceptable Plan?The new ORAL DARFis not in use as per thePMB required date ofSeptember 1, 2014 fortwo studies.Two new sections have beenadded to our Pharmacy policy(see attached). One ismandating use of Oral DARFand the other is to include theCTMB Guidelines section 5.3.Pharmacy staff have been reeducated.
Treatment DeficiencyMajor DeficiencyAcceptable orUnacceptable Plan?Dose modification errorfor Cycle 4. A 25% dosewas warranted and thepatient received a 40%dose reduction. This isgreater than 10% marginof error.“In reviewing these,I believe she did a verygood job overall, but therewere some confusing itemswhich were misinterpreted.I believe that with herexperience now, the nextcase would be muchbetter.”
Data Quality DeficiencyMajor DeficiencyAcceptable orUnacceptable Plan?Per the Alliance“This was an isolatedPathology Coordinatingevent and we do not feel itOffice, the study required will occur again.”blood samples and blockswere not submitted.
Data Quality DeficiencyMajor DeficiencyAcceptable orUnacceptable Plan?Data forms for treatment,AE and disease responsehave not been submittedsince cycle #7 (11/19/12).Patient had progressivedisease on 11/26/2013.All forms have beensubmitted. The cancercenter has hired anadditional experiencedCRA. Monthly staffmeetings will cover datasubmission schedules.A quarterly review of datawill be performed by theoffice manager.”
Two ConsecutiveUnacceptable Ratings?(In the same component)CTMB section 6.3.2: Probation of ParticipatingInstitutions The institution will be placed on probation The Group may assign a mentor A “site improvement plan” must be developed to“address key infrastructural issues contributing to poorperformance”(ALL of this in addition to the corrective andpreventative action plan.)
Example: Site ImprovementPlan for IRB The local IRB policies were revised inresponse to the audit findingsThe main member network will cover thecosts of the site’s CRP to attend the auditprep workshop at the next Alliance groupmeetingThe Lead CRP will perform two IRB audits ofthe affiliate over the next year
Contact Informationl Barbara Barrettl l l bbarrett@uchicago.eduPhone: (312) 206-8216Fax: (312) 345-0117
Additional Contact Informationl Josh Lachewitz, Audit Coordinatorl l l jlachewitz@uchicago.eduPhone: (773) 702-9973Fax: (312) 345-0117
Questions?
Thank you!
2014 Fall Group MeetingNovember 6 – 9 / Chicago, IL
Feb 15, 2014 · Exit Interview - don’t be afraid to a
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