AUDIT

审计

• 批准号: 7515876
• 负责人: CHARLES L LOPRINZI
• 金额: $ 10.47万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-14 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7515876
• 关键词: Address; Adherence; Adverse event; Affect; Appendix; Categories; Clinical Trials; Data; Data Quality; Databases; Disease Outcome; Dose; Electronics; Eligibility Determination; Ensure; Evaluation; Goals; Individual; Informed Consent; Monitor; North Central Cancer Treatment Group; Process; Productivity; Protocols documentation; Quality Control; Reporting; Resolution; Severities; Site; Specialist; System; Toxic effect; Training and Education; Writing; day; follow-up; human subject; response; user-friendly

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.

2.8.1.6 内部审计 NCCTG 质量控制部门进行严格的内部审核，以验证内部是否遵守 SOP、 正确使用自动化系统以及内部一致性。这些审计的目的是进一步确保 研究数据的质量，确保提供准确、及时、可靠的试验结果，并提供 对员工的教育支持。在进行这些审核的同时，还会对电子申请进行审核，以确保 确保系统被正确使用，确保系统用户友好且正常运行， 并确定提高单位整体效率和生产力所需的任何改进。 审核至少每年进行一次，持续一到两天。研究是随机选择的 为每位质量控制专家至少选择 2-5 个案例。审核检查表用于确保 图表的全面审查。资格、客观反应、剂量、不良事件报告以及 审查编辑的及时性。审计的第二个目标是确保系统正常运行 正确使用是通过验证是否识别了正确的编辑来完成的，案例评估 在适当的时候触发审查，并且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 在收到后三十天内解决并澄清任何关注的事项。质量控制专家主管 与培训和教育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 年接受一次审核，以进一步确保提供准确和可靠的信息 可靠的临床试验数据和结果，验证提交数据的准确性，监控对临床试验的遵守情况 研究方案，以验证是否遵守保护人类受试者的监管要求和 处理调查代理人，并向 NCCTG 会员提供教育支持。这 这些审计结果由 NCCTG 审计委员会审查，该委员会负责监督审计过程 NCCTG 并直接向 NCCTG 执行委员会报告。个别图表审核的结果是 按类别总结（知情同意、资格、治疗、疾病结果、毒性和一般数据 质量）和差异的严重程度（较小或较大）。重大缺陷的比例仍然较低 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 发送一份备忘录 现场与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。审计报告包含在内 附录十一。