DATA SAFETY & MONITORING/ QUALITY ASSURANCE

项目摘要（参见说明）： 目标：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) 的 QA 和 DSM 总体目标仍然是双重的：1) 确保参与研究的所有人类受试者的安全和道德治疗； 2) 验证所有收集的数据的准确性、完整性、有效性和完整性。多个委员会和流程共同促成了这一成就 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) 内流程的各个方面，并向 UCCC 执行委员会和 COMIRB 报告；并监督向赞助商和联邦机构（例如 NCI AdEER）报告 AE 和 SAE。 UC Anschutz 医学校区 (AMC) 和 UCCC 通过 UCCC CICSR 继续合作，提高临床试验流程的效率和准确性 与 COMIRB 的互动，包括 COMIRB 主任（Alison Lakin，注册护士，博士）、合规副校长（Angela Wishon，法学博士）以及其他团体，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)。这些合作促成了 2008 年 CTSA 的成功申请（科罗拉多临床转化科学研究所）。 CICSR 教育委员会确定 开发并提供各种教学活动，以提高知识，从而提高所有 CIC 工作人员对临床试验管理的遵守程度。 Pis 和合作调查员。培训：正式的 CICSR 教育委员会于 2004 年 8 月召开，目前仍相当活跃。成员是 CICSR 工作人员，包括所有疾病现场团队、监管事务和行政部门。教育目的 活动的目的是确保临床试验的高质量实施和分析，具体目标仍与竞争更新中提出的一致。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 人类受试者研究均受到该核心的监督。定期对选定的试验（尤其是研究者发起的试验）进行审核，并且该核心的 PQASC 还为不进行试验的试验提供数据安全监控委员会 (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.