Clinical Protocol, Data Management and Informatics Shared Resource

临床方案、数据管理和信息学（CPDMI）共享资源在临床研究委员会的监督下管理新墨西哥大学（UNM）癌症中心的临床肿瘤学研究。CPDMI的医学主任是D. Jones，他在临床肿瘤学研究方面拥有丰富的经验，执行主任是T. Stewart。该共享资源的当前预算（2008/9财年）为130万美元。CPDMI由1名医疗主任、1名执行主任、1名监管经理、1名质量保证经理、1名数据库管理员、4名监管协调员、2名行政助理、1名人类保护专家和1名项目经理/会计组成。CPDMI包括由Kroth领导的临床信息学工作，该工作有4个FTE，以及由Eberhardt领导的临床试验成像工作。该共享资源的主要目标是为临床试验过程提供支持，包括实施和规范试验，并提供集中的临床试验数据库，研究药房支持，财务会计，数据安全监控和质量保证。这个共享资源也帮助医师调查员设计和随后的临床试验。它执行所有监管报告和质量保证，以遵守临床试验的良好临床实践。的CPDMI

The Clinical Protocol, Data Management and Informatics (CPDMI) Shared Resource administrates clinical oncology research at the University of New Mexico (UNM) Cancer Center under the supervision of the Clinical Research Committee. The Medical Director of the CPDMI is D. Jones, who has extensive experience in clinical oncology research, and the Executive Director is T. Stewart. This Shared Resource has a current budget (FY2008/9) of $1.3 million. The CPDMI consists of 1 Medical Director, 1 Executive Director, 1 Regulatory Manager, 1 Quality Assurance Manager, 1 Database Administrator, 4 regulatory coordinators, 2 administrative assistants, 1 human protection specialists, and 1 Program Manager/accountant. The CPDMI includes a clinical informatics effort led by Kroth, which has 4 FTE, and a clinical trials imaging effort led by Eberhardt. The major goal of this Shared Resource is to provide support of the clinical trial process, including implementing and regulating trials, and providing a centralized clinical trial database, investigational pharmacy support, financial accounting, data safety monitoring, and quality assurance. This Shared Resource also assists physician investigators in the design and subsequent conduct of clinical trials. It performs all regulatory reporting and quality assurance needed to comply with Good Clinical Practice in the performance of clinical trials. The CPDMI has created Standardized Operating Procedures for all its activities, including training of all new faculty and staff. In FY2008/9, the CPDMI Shared Resource administrated 327 Cancer Center protocols, of which 114 were therapeutic/interventional trials. These therapeutic trials are also open within the New Mexico Cancer Care Alliance, the consortium of community oncologists affiliated with the UNM Cancer Center. At UNM Cancer Center outpatient clinics, 2640 new cancer patients (Summary 3) were treated in fiscal year 2009, and there were 443 accruals to therapeutic trials (17% of new patients), with an additional 101 therapeutic accruals supervised by the CPDMI at the Alliance affiliate sites. Accruals to all types of trials using the CPDMI were 1241 in fiscal year 2009. Of patients accrued to therapeutic clinical trials, 83% were women, 7% were Native Americans, and 44% were Hispanics. The UNM Cancer Center patient population had 56% women, 11% Native Americans, and 34% Hispanics. Additionally, the CPDMI reviewed 137 subject records as part of internal audits at UNM Cancer Center and affiliate sites.