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SOP， 正确使用自动化系统和内部一致性。这些审计的目标是进一步确保 研究数据的质量，以确保提供准确、及时和可靠的试验结果，并提供 对员工的教育支持。在进行这些审计的同时，对电子申请进行审查， 确保系统得到正确使用，确保系统易于使用且运行正常， 并确定任何必要的改进，以提高该单位的整体效率和生产力。 审计至少每年进行一次，持续一到两天。随机选择研究， 每个质量控制专家至少选择2-5个病例。审计检查表用于确保 全面审查图表。合格性、客观缓解、给药、不良事件报告和 审查了编辑的及时性。审计的第二个目标是确保系统正常运作， 正确使用是通过验证是否识别出正确的编辑、案例评估来实现的 审查在适当时启动，材料跟踪系统得到正确实施。 审核完成后，每位质量控制专家都会收到一份书面审核报告，并被要求 在收到后30天内处理并澄清任何关注事项。质量控制专家主管 与质量控制专家一起审查所有答复的可接受性和后续培训和教育 需求 2.8.1.7外部审计 所有NCCTG成员至少每3年审核一次，以进一步确保提供准确和 可靠的临床试验数据和结果，验证提交数据的准确性，监测对 研究方案，以验证是否符合保护人类受试者的法规要求， 处理研究药物，并为NCCTG成员提供教育支持。的 这些审计的结果由NCCTG审计委员会审查，该委员会负责监督审计过程， 并直接向NCCTG执行委员会汇报。个人病历审查的结果如下 按类别总结（知情同意、合格性、治疗、疾病结局、毒性和一般数据 质量）和差异的严重性（较小或较大）。主要缺陷的百分比仍然很低， 主要缺陷的中位数百分比低于5%（2001年= 3%，2002年= 4%，2003年= 3%，2004年= 1%，2005年=2%）。 当发现可能影响提交数据的缺陷时，将向主要CRA 在研究中心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，直到在数据库中得到解决。审计报告作为 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.