CENTRALIZED PROTOCOL AND DATA MANAGEMENT UNIT

集中式协议和数据管理单元

• 批准号: 7680060
• 负责人: Joseph A. Sparano
• 金额: $ 45.31万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7680060
• 关键词: AIDS Malignancy Consortium; Address; Adverse event; Albert Einstein Cancer Center; Amendment; Annual Reports; Authorization documentation; Bioinformatics; Bioinformatics Shared Resource; Biostatistics Shared Resource; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Case Report Form; Cataloging; Catalogs; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collection; Consent; Consent Forms; Contracts; Data; Data Analyses; Data Collection; Data Quality; Databases; Development; Discipline; Dose; Drug Industry; Eastern Cooperative Oncology Group; Education; Eligibility Determination; Enrollment; Evaluation; Floor; Funding; Grant; Guidelines; Health Insurance Portability and Accountability Act; Industry; Laboratories; Medical center; Modification; Monitor; Numbers; Patients; Performance; Pharmacy facility; Phase; Play; Process; Protocols documentation; Quality Control; Regulatory Affairs; Reporting; Research Ethics Committees; Research Infrastructure; Research Institute; Research Personnel; Research Support; Resources; Role; Safety; Schedule; Services; Site; System; Toxic effect; Training; Translating; Travel; United States Food and Drug Administration; anticancer research; data management; member; performance tests; protocol development; response; translational clinical trial

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.

CPDMU是成员从各个肿瘤学科广泛使用的共享AECC资源 执行临床和翻译试验。 CPDMU扮演着支持其他组成部分的核心角色 临床试验基础设施包括协议审查和监测系统（PRMS），协议 特定的研究支持（PSR）以及数据与安全监测委员会（DSMC）。 CPDMU 行政办公室位于蒙特菲奥尔医疗中心Weiler部的二楼 （MMC），并紧接与CPDMU主任的行政办公室和Chanin相邻 癌症研究所。 CPDMU执行以下功能：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，并为需要的AECC调查人员提供资源 在设计临床试验方面的帮助。提供的服务包括：编目，准备和提交所有服务 新的临床协议，知情同意文件以及HIPAA授权文件向PRMS和 到AECOM CCI和/或MMC IRB。其他服务包括准备西班牙版的知情 同意文件，符合CCI/IRB指南，以完全翻译为非英语的同意书 主体对所有内部的所有修正案，收集，处理和分配的分类和提交 以及外部不利事件，包括分配给IRB和政府机构，启动所有新的 临床方案，提交序列编号向药房的提交（确保所有患者参加临床 适当地输入临床数据库），监督资格检查，注册和注册 在新患者中，监督适当收集的数据，记录毒性，剂量修改，性能 及时进行测试，及时提交形式的表格以及计划和表现 后续行动。大约有25 f.t.e。 CPDMU由CCSG资助。临床试验是 由N01 II期合同（CA CM-17103），ECOG U10 Grant（CA14959）的支持，AIDS恶性肿瘤 联盟U01核心网站分包，以及研究人员发射的NCI和药品的资金 行业研究。