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UCCC进行最高质量、最安全、最精确的临床癌症研究。结构和服务：科罗拉多大学癌症中心（UCCC）QA和DSM的总体目标有两个方面：1）确保参与研究的所有人类受试者的安全性和伦理治疗; 2）验证收集的所有数据的准确性、完整性、有效性和完整性。多个委员会和进程有助于实现 这些目标。UCCC方案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报告;监督向申办者和联邦机构报告AE和SAE，例如，NCI AdEER。通过UCCC CICSR，UC Anschutz Medical Campus（AMC）和UCCC继续开展合作，以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）、合规副校长（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UCCC方案审查和监测委员会（PRMC）。这些合作为2008年成功申请CTSA做出了贡献（科罗拉多临床转化科学研究所）。CICSR教育委员会确定 开发并提供各种指导活动，以提高临床试验的质量，从而提高所有CIC工作人员对临床试验管理的依从性。私家侦探和合作调查员。培训：2004年8月召开了一个正式的CICSR教育委员会会议，该委员会仍然十分活跃。成员为CICSR工作人员，包括所有疾病研究中心团队、法规事务部和行政部。教育的目的 活动旨在确保临床试验的高质量实施和分析，具体目标仍如竞争性更新中所述。四个小组委员会提供所需的培训：监督继续教育，方向和能力利用：所有UCCC人类受试者的研究都受到这个核心的监督。定期对选定的试验进行稽查，特别是由制药商发起的试验，该核心的PQASC还为不符合以下条件的试验提供数据安全性监测委员会（DSMB） 有指定的DSMB。

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.