CENTRALIZED PROTOCOL AND DATA MANAGEMENT UNIT

CPDMU是一个共享的AECC资源，被来自各个肿瘤学科的成员广泛使用， 进行临床和转化试验。CPDMU发挥着核心作用，支持其他组成部分， 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（PSRS）和数据和安全性监查委员会（DSMC）。CPDMU 行政办公室位于Montefiore医疗中心Weiler分部的二楼 (MMC)，紧邻CPDMU主任的行政办公室和Chanin 癌症研究所。CPDMU执行以下功能：方案提交、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， 协助设计临床试验。提供的服务包括：编目，准备和提交所有 PRMS的新临床方案、知情同意文件和HIPAA授权文件，以及 AECOM CCI和/或MMC IRB。其他服务包括编写西班牙文版的 同意文件，符合CCI/IRB指南，为非英语国家提供完全翻译的同意书 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，包括分发给IRB和政府机构，启动所有新的 临床方案，向药房提交序列号（确保所有参加临床试验的患者 试验正确地输入临床数据库），监督资格检查、注册和入组 新患者，监督数据的正确收集、毒性记录、剂量调整、性能 及时进行测试，及时提交表格，以及安排和执行 后续行动。大约有25个F.T.E. CPDMU工作人员由CCSG资助。临床试验 由N 01第二阶段合同（CA CM-17103）、ECOG U10补助金（CA 14959）、艾滋病疫苗（AIDS） 联盟U 01核心站点的开发，沿着来自制药商发起的NCI和制药公司的资金 工业研究。

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.