1. AUDIT PROGRAM Tammy Neseth NCCTG Compliance Coordinator

2. CPxxxxxxx-2 AUDIT COMMITTEE MEMBERSHIP Research Base Chair: Thomas Habermann, MD Community Co-Chair: Philip Stella, MD Community-Based Practice PI's: 8 Community-Based CRAs: 7 Other Research Base Personnel: 7

3. CPxxxxxxx-3 PURPOSE Oversee the audit process Review audit results to ensure compliance and communication of the NCI’s audit guidelines Implement policies and procedures to ensure consistency in how audits are conducted and results managed

4. CPxxxxxxx-4 PURPOSE Facilitate communication and ensure that the educational element is present during on-site process Communicate outcomes, trends and issues to the Executive Committee of the NCCTG and influence policy Enhance communication with the CCOP and non-CCOP membership institutions and with the Clinical Trials Monitoring Branch (CTMB)

5. CPxxxxxxx-5 DISTINGUISHING CHARACTERISTICS A premise that this is a key quality control and CRA development aspect of the NCCTG Pre-audits are performed prior to the majority of audits Integrated multi-group approach: NCCTG cancer treatment, Cancer Control, intergroup, ECOG, and CTSU

6. CPxxxxxxx-6 DISTINGUISHING CHARACTERISTICS All NCCTG audits are overseen by NCCTG Compliance Coordinator Team approach to the chart at the audit: Physician and CRA from NCCTG Audit team along with CRA from site An extensive exit interview is held with the membership immediately following the audit

7. CPxxxxxxx-7 DISTINGUISHING CHARACTERISTICS An Audit Executive Review Committee formed in October of 2002 Thresholds: 8% for major deficiency rates or 30% overall deficiency rate Committee membership: Research Base Chair of the Audit Committee, the NCCTG Group Statistician, the NCCTG Statistician member of the Audit Committee and the NCCTG Compliance Coordinator

8. CPxxxxxxx-8 DISTINGUISHING CHARACTERISTICS Institutional Evaluation and Assessment Participation as an auditor and auditing outcomes are included in the formal evaluation of NCCTG membership performance as of 2005

9. CPxxxxxxx-9 KEY ACCOMPLISHMENTS Enhancements of the educational component of the NCCTG Audit Program All new NCCTG memberships are required to attend an orientation session which includes “ABCs of Auditing” Education and system based practice initiatives at the exit interviews of audits have been more emphasized

10. CPxxxxxxx-10 KEY ACCOMPLISHMENTS A $500 supplement for sites that send new CRAs on an audit was initiated. The purpose of this is to expose new CRAs to the clinical trials process and the audit process The Audit Manual and the Pharmacy Manual are continually updated and were posted on the NCCTG web site in 2004

11. CPxxxxxxx-11 SITE AUDIT TIPS Provide a room for the audit Confirm staff/investigator availability Prepare staff Flag charts Order scans/x-rays Be ready to start the audit when audit team arrives

12. CPxxxxxxx-12 AUDIT ISSUES IRB and Informed Consent Review Informed consent document sent to Auditor for review not the most current IRB approved form No organization of IRB correspondence - approval letters, AE submissions

13. CPxxxxxxx-13 AUDIT ISSUES Accountability of Investigational Agents and Pharmacy Operations Agents not stored separately Satellite DARFs not available Write-overs on the DARFs

14. CPxxxxxxx-14 AUDIT ISSUES Informed Consent – re-consenting Eligibility - physician notes Treatment – oral compliance Disease Outcome/Response – scans Adverse Events/Study Parameters – test schedule, toxicity assessments, dose modifications General Data Quality – corrections, timeliness

15. CPxxxxxxx-15 QUOTE OF THE DAY “If not documented – it didn’t happen.” - Roxanne Tabery 6/28/2005