DATA SAFETY & MONITORING/ QUALITY ASSURANCE

项目总结(见说明)： 目的：QA DSM共享资源的总体目的是确保在UCCC进行最高质量、最安全、最准确的临床癌症研究。结构和服务：科罗拉多大学癌症中心(UCCC)QA和DSM的总体目标仍然是两个：1)确保所有参与研究的人类受试者的安全和合乎道德的治疗；2)验证收集的所有数据的准确性、完整性、有效性和完整性。多个委员会和进程促成了这一成就 这些目标。UCCC协议质量保证和安全委员会(PQASC)监督UCCC临床研究核心共享资源(CICSR)内流程的所有方面，并向UCCC执行委员会和COMIRB提交报告；并监督向赞助商和联邦机构(如NCI AdEER)报告不良事件和安全事件。加州大学安舒茨医学院(AMC)和UCCC继续通过UCCC CICSR共同努力提高临床试验过程的效率和准确性 与COMIRB的互动包括COMIRB主任(Alison Lakin，RN，PhD)、负责遵从性的副校长(Angela Wishon，JD)和其他团体，如医学院临床试验研究咨询委员会(CTRAC)，以及重要的是UCCC的方案审查和监测委员会(PRMC)。这些合作为2008年CTSA的成功应用做出了贡献(科罗拉多州临床转化科学研究所)。CICSR教育委员会确定 开展和提供各种教学活动，以提高L的知识水平，从而提高CIC全体员工对临床试验管理的遵从性。PIS和联合调查员。培训：2004年8月召开了CICSR正式教育委员会会议，目前仍相当活跃。成员是CICSR的工作人员，包括所有疾病现场团队、监管事务和行政部门。教育的目的 活动是为了确保临床试验的高质量进行和分析，具体目标仍然是竞争续签中提出的。四个小组委员会提供所需的培训：监督、继续教育、定向和能力利用：所有UCCC人类主题研究都受到该核心的监督。对选定试验的审计，特别是由调查员发起的审计，定期进行，该核心的PQASC还为没有 有一个指定的数字用户群管理系统。

PROJECT SUMMARY (See instructions): Objective: The overall purpose of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC. Structure and services: The overall goal of QA and DSM for the University of Colorado Cancer Center (UCCC) remains twofold: 1) insure the safety and ethical treatment of all human subjects participating in research; 2) verify the accuracy, completeness, validity and integrity of all data_collected. Multiple committees and processes contribute to the achievement of these goals. UCCC Protocol Quality Assurance and Safety Committee (PQASC) oversees all aspects of the process within the UCCC Clinical Investigations Core Shared Resource (CICSR) and reports to the Executive Committee of the UCCC, and to COMIRB; and oversees reporting of AEs and SAEs to sponsors and federal agencies, e.g., NCI AdEERs. Collaborative efforts to improve the efficiency and accuracy of the clinical trials process at UC Anschutz Medical Campus (AMC) and UCCC continue through UCCC CICSR interactions with COMIRB including the Director of COMIRB (Alison Lakin, RN, PhD), the Associate Vice Chancellor for Compliance (Angela Wishon, JD) and other groups such as the School of Medicine Clinical Trials Research Advisory Committee (CTRAC) and importantly the protocol review and monitoring committee (PRMC) of the UCCC. These collaborations have contributed to the successful CTSA application in 2008 (Colorado Clinical Translational Sciences Institute). The CICSR Education Committee identifies develops and offers a variety of instructional activities to improve the l<nowledge and thus the compliance with the management of clinical trials by all CIC staff. Pis and co-investigators. Training: A formal CICSR Education Committee was convened in August, 2004, and remains quite active. Members are CICSR Staff and include all Disease Site teams, Regulatory Affairs and Administration. The aims of the education activities are to insure high quality conduct and analysis of clinical trials and the specific objectives remain as presented in the Competing Renewal. Four subcommittees provide the needed training: oversight continuing education, orientation and competency Utilization: All UCCC human subject research is subject to oversight by this core. Audits of selected trials, especially investigator-Initiated, are conducted periodically, and the PQASC of this core also provides a data safety monitoring board (DSMB) for trials which do not have a designated DSMB.