DATA SAFETY & MONITORING/ QUALITY ASSURANCE

数据安全

• 批准号: 8465403
• 负责人: MADELEINE A. KANE
• 金额: $ 7.22万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-06 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8465403
• 关键词: Achievement; Advisory Committees; Applications Grants; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Colorado; Continuing Education; Data; Disorder by Site; Doctor of Philosophy; Education; Ethics; Funding; Goals; Human Subject Research; Industry; Institutes; Institution; Instruction; Knowledge; Medical; Mission; Monitor; Patients; Process; Protocols documentation; Regulatory Affairs; Reporting; Research; Research Personnel; Resource Sharing; Safety; Services; Structure; The University of Colorado Cancer Center; Training; Training Programs; Translational Research; Universities; anticancer research; human subject; improved; medical schools; member; programs; quality assurance

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.

项目概述（见说明）：