AUDIT

审计

基本信息

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
项目类别：
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

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

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项目摘要

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内部审核 NCCTG质量控制单元进行严格的内部审核，以验证内部遵守SOP的遵守适当使用自动化系统和内部一致性。这些审核的目的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。与这些审核同时，将电子应用程序审查为确保正确使用系统，确保系统用户友好且运行正常，并确定提高单元的总体效率和生产率所需的任何改进。审核至少每年一次，持续一到两天。与AT一起随机选择研究为每个质量控制专家选择至少2-5个案例。审核检查清单用于确保图表的全面审查。资格，客观响应，剂量，不良事件报告和审查了及时的编辑。审核的第二个目标，确保系统运行，并且正确使用，通过验证确定正确的编辑，该案例评估来完成在适当的时候触发了评论，并正确实施了材料跟踪系统。审核完成后，每个质量控制专家都会收到书面审核报告，并要求在收到后的三十天内解决并澄清任何关注的物品。质量控制专家主管审查所有答复，以接受可接受性和对培训和教育的质量控制专家的跟进需要。 2.8.1.7 NCCTG外部审核所有NCCTG成员资格至少每3年进行一次审核，以进一步确保提供准确的和可靠的临床试验数据和结果，以验证提交数据的准确性，以监视对研究方案，以验证对保护人类受试者的遵守要求处理研究代理商，并为NCCTG成员提供教育支持。这 NCCTG审计委员会对这些审核的结果进行了审查，该委员会监督了审计过程 NCCTG并直接向NCCTG执行委员会报告。个人图表审查的结果是按类别进行总结（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（较小或主要）。主要缺陷的百分比仍然很低低于5％（2001 = 3％，2002 = 4％，2003 = 3％，2004，2004，2004，2005，2005 = 2％）的主要缺陷中位数中位数。当发现潜在影响提交数据的缺陷时，将备忘录发送到两个主要CRA 在网站和质量控制专家传达数据差异。质量控制专家然后负责跟踪查询，直到数据库中的分辨率为止。审核报告包括附录XI。