AUDIT

2.8.1.6内部审计 NCCTG质量控制部门进行严格的内部审核，以验证内部是否符合标准操作规程； 自动化系统的正确使用，以及内部一致性。这些审计的目标是进一步确保 研究数据的质量，以确保交付准确、及时和可靠的试验结果，并提供 对员工的教育支持。与这些审计同时，电子申请也会被审查，以 确保正确使用系统，确保系统对用户友好并正常运行， 并确定任何必要的改进，以提高单位的整体效率和生产率。 审计至少每年进行一次，持续一到两天。研究是随机选择的，在 每个质量控制专家至少选择2-5个案例。审计核对表用于确保 全面回顾图表。资格、客观反应、剂量、不良事件报告，以及 对编辑的及时性进行了回顾。审计的第二个目标是确保系统正常运行和 正确使用，是通过验证是否识别了适当的编辑、案例评估 在适当的时候触发了审查，并确保正确实施了材料跟踪系统。 完成审核后，每位质量控制专家将收到一份书面审核报告，并被要求 在收到邮件后30天内解决并澄清任何关注的事项。质量控制专家监督员 与培训和教育方面的质量控制专家一起审查所有答复的可接受性和后续行动 需要。 2.8.1.7 NCCTG外部审计 所有NCCTG会员至少每3年审核一次，以进一步确保交付准确和 可靠的临床试验数据和结果，以验证提交的数据的准确性，监测对 研究方案，以验证遵守保护人类受试者和 处理调查人员，并为NCCTG成员提供教育支持。这个 这些审计的结果由NCCTG审计委员会审查，该委员会监督以下审计过程 NCCTG并直接向NCCTG执行委员会报告。个别图表评审结果如下 按类别(知情同意、资格、治疗、疾病结局、毒性和一般数据)汇总 质量)和差异的严重程度(较小或较大)。主要缺陷的比例仍然很低， 低于5%的主要缺陷的中位数百分比(2001年=3%，2002年=4%，2003年=3%，2004年=1%，2005年=2%)。 当发现可能影响已提交数据的缺陷时，将向两个主要CRA发送一份备忘录 在现场和质量控制专家沟通数据差异。质量控制专家 然后负责跟踪查询，直到数据库中的解析。一份审计报告包括在 附录XI。

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.