AUDIT

2.8.1.6 Internal Audits The NCCTG Quality Control Unit conducts rigorous internal audits to verify internal compliance with SOPs, proper use of automated systems, and internal consistency. The goal of these audits is to further assure the quality of the study data, to ensure the delivery of accurate, timely and reliable trial results, and to provide educational support to the staff. Concurrently with these audits, the electronic applications are reviewed to ensure that systems are being used correctly, ensure the systems are user friendly and functioning properly, and identify any improvements necessary to increase the overall efficiency and productivity of the unit. The audits are conducted at least annually and last one to two days. Studies are selected randomly with at least 2-5 cases being chosen for each Quality Control Specialist. An audit check list is used to ensure a comprehensive review of charts. Eligibility, objective response, dosing, adverse event reporting, and timeliness of editing are reviewed. The second objective of the audit, ensuring systems are functioning and being used correctly, is accomplished by verifying that the proper edits were identified, that case evaluation reviews were triggered when appropriate, and that the materials tracking system was correctly implemented. Upon completion of the audit, each Quality Control Specialist receives a written audit report and is asked to address and clarify any items of concern within thirty days of receipt. The quality control specialist supervisor reviews all responses for acceptability and follow-up with the quality control specialist on training and education needs. 2.8.1.7 NCCTG External Audit All NCCTG memberships are audited at least once every 3 years to further ensure the delivery of accurate and reliable clinical trials data and results, to verify the accuracy of submitted data, to monitor compliance to the study protocol, to verify adherence to regulatory requirements for the protection of human subjects and the handling of investigational agents, and to provide educational support to the NCCTG memberships. The results of these audits are reviewed by the NCCTG Audit Committee who oversees the audit process for NCCTG and reports directly to the NCCTG Executive Committee. The results of individual chart review are summarized by category (informed consent, eligibility, treatment, disease outcome, toxicity, and general data quality) and severity of discrepancy (lesser or major). The percent of major deficiencies has remained low with the median percent of major deficiencies below 5% (2001=3%, 2002=4%, 2003=3%, 2004=1%, 2005=2%). When deficiencies are identified that potentially affect submitted data, a memo is sent to both the primary CRA at the site and the quality control specialist communicating the data discrepancy. The quality control specialist is then responsible for tracking the query until resolution in the database. An audit report is included as Appendix XI.