Preparing your Audit Response Communication with the Central Office

Transcription

1 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 Office

2 Post-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.

3 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 Investigator

4 After 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. 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.

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! 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 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.

6 Sample Audit Reports and Cover Letters

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9 After 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.

10 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.

11 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? Submit all supporting documentation! Samples of Acceptable/Unacceptable Corrective Action Plans

12 This CAP provides a very detailed plan for how the institution will submit updates in a timely manner. They also indicate who is responsible for this plan and offer a timeline for implementation.

13 The corrective action provided here is Acceptable; however, I would follow-up with this institution to ensure that the outstanding SAEs have now been submitted. Documentation of SAE submission should also be provided. 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!

14 While inadequate staffing may have been the primary reason for the deficiencies in all categories, increasing staffing, or any broad corrective plan, is not sufficient. CAPs need to address the specific problems that have been found in each category. What will additional staff do differently to ensure that the particular problems identified at the audit will not reoccur?

15 This institution received multiple deficiencies for delinquent data submission. While the plan for addressing data delinquency in the future may be sufficient, they provide no assurance or documentation that the all the delinquent data identified at audit has been submitted. Contested deficiencies Because deficiencies on audit reports are considered final per CTMB policy, it is very important that you communicate with your Audit Team, your Team Leader BEFORE the Audit report is issued.

16 Contested Deficiencies Before contesting deficiencies, ask questions at your exit interview. Follow-up with your Team Leader via about any outstanding questions or issues. When contesting deficiencies, reference the exact deficiency you contest and include all supporting documentation. Remember: Deficiencies are usually not removed from audit reports. Was this information available to the auditors? Contested Deficiency Sample Delinquent Data Submission: The Eligibility checklist has not been submitted (was due_/_/04). Form C-, tumor measurement forms, treatment forms, and donor cell product form for Days 7-30 have not been submitted.

17 Preventing Suspension of Patient Accrual Submit complete corrective action plan in timely manner. Respond to any inquiries from Audit Specialist promptly and submit a revised CAP, if requested. CTMB Review After the CALGB submits the CAP to the CTMB, the CTMB reviews the CAP. If the CTMB has questions about a CAP, it will direct them to the CALGB. The Audit Specialist will contact the institution regarding any follow-up questions from the CTMB.

18 Additional Resources urces/audit/audit_resources.php Contact Information Sally Scherer, Audit Specialist 230 W. Monroe, Suite 2050 Chicago, IL Phone: (773) Fax: (312)

19 Questions?