CENTRALIZED PROTOCOL AND DATA MANAGEMENT UNIT

CPDMU是一个共享的AECC资源，被来自不同肿瘤学学科的成员广泛使用 进行临床和转化性试验。CPDMU发挥着核心作用，支持 临床试验基础设施包括方案审查和监测系统(PRMS)、方案 具体研究支持(PSR)以及数据和安全监测委员会(DSMC)。CPDMU 行政办公室位于蒙蒂菲奥里医疗中心韦勒分部二楼 (MMC)，紧邻CPDMU主任办公室和Chanin 癌症研究所。CPDMU执行以下职能：协议提交、监管 事务、数据管理和开发，促进与生物信息学和生物统计学的互动 共享资源，提供质量控制，并作为AECC调查人员的资源，他们需要 协助设计临床试验。提供的服务包括：编目、准备和提交所有 新的临床方案、知情同意文件和HIPAA授权文件提交给PRMS和 至AECOM CCI和/或MMC IRB。其他服务包括准备西班牙语版的《知情人士》 同意文件，符合CCI/IRB关于非英语国家完全翻译的同意书指南 主题编目和提交所有修订，收集、处理和分发所有内部 和外部不良事件，包括向IRB和政府机构分发，启动所有新的 临床方案，向药房提交序列号(确保所有患者在临床上登记 试验被适当地输入临床数据库)，监督资格检查、登记和登记 新患者，监督适当的数据收集，毒性记录，剂量修改，性能 及时进行测试，及时提交表格，并安排和执行 后续行动。大约有25名FT.E.CPDMU的工作人员由CCSG提供资金。临床试验是 由N01第二阶段合同(CA CM-17103)、ECOG U10赠款(CA14959)、艾滋病恶性肿瘤支持 财团U01核心站点分包，以及由调查员发起的NCI和制药公司提供的资金 行业研究。

The CPDMU is a shared AECC resource widely used by members from the various oncologic disciplines to perform clinical and translational trials. The CPDMU plays a central role that supports other components of the clinical trials infrastructure including the Protocol Review and Monitoring System (PRMS), Protocol Specific Research Support (PSRS), and Data and Safety Monitoring Committee (DSMC). The CPDMU administrative office is located on the second floor of the Weiler Division of Montefiore Medical Center (MMC), and is immediately adjacent to the administrative office of CPDMU Director and to the Chanin Cancer Research Institute. The CPDMU performs the following functions: protocol submission, regulatory affairs, data management and development, facilitates interactions with the Bioinformatics and Biostatistics Shared Resources, provides quality control, and serves as a resource for AECC investigators who require assistance in the design of clinical trials. Services provided include: cataloging, preparing, and submitting all new clinical protocols, informed consent documents, and HIPAA authorization documents to the PRMS and to the AECOM CCI and/or MMC IRB. Additional services include preparing a Spanish version of informed consent documents, conforming to CCI/IRB guidelines for a fully translated consent for non-English speaking subjects cataloging and submission of all amendments, collection, processing and distribution of all internal and external adverse events including distributions to IRB and governmental agencies, initiation of all new clinical protocols, submission of sequence numbers to pharmacy (insuring that all patients enrolled in clinical trials are properly entered into the clinical database), overseeing eligibility check, registration and enrollment of new patients, overseeing proper collection of data, recording of toxicities, dose modifications, performance of tests in a timely fashion, submission of forms in a timely fashion, and scheduling and performance of follow-ups. There are approximately 25 F.T.E. CPDMU staff funded by the CCSG. Clinical trials are supported by a N01 Phase II Contract (CA CM-17103), ECOG U10 grant (CA14959), AIDS Malignancy Consortium U01 core site subcontract, along with funding from investigator-initiated NCI and pharmaceutical industry studies.