PEDIATRIC PHARMACOLOGY RESEARCH UNITS

中央业务管理办公室的职能是：(1) 整合所有十三个单位的业务；(2)达到或超过 FDA和制药公司的报告要求；(3)至 促进PPRU、FDA和行业之间的沟通 (制药公司和合同研究机构)；(4) 确保在具有成本效益的情况下进行儿科临床试验 (5)开发和维护信息系统 用于指定的任务；以及(6)监控由指定的 参数。 中央办公室执行以下任务：(1)发展和 维护临床试验数据管理系统；(2)开发 和维护信息系统，以跟踪和维护 购置、启动、进度、完成、报告、摘要和 参与PPRU研究的所有药物的标签状况；(3)发展 数据管理标准程序手册；(4)分析和 根据FDA和制药公司的要求生成报告 和开发审计跟踪；(5)分析和生成年度 和定制报告；(6)制定不良体验报告 系统；(7)制定与制药公司的标准化合同 为各单位提供协助；(8)协助谈判和管理 与工业界签订合同；(9)评估当前和今后的需要 网络和增长评估，包括财务和商业 预测；(10)维持合规评估、登记 个别单位的表现和成功率；(11)发展 使现场监测标准化的程序；和(12)准备和 维护所有运营文件、政策和程序 PPRU网络。

The functions of the Central Operating and Management office are: (1) to integrate the operations of all thirteen units; (2) to meet or exceed reporting requirements of FDA and Pharmaceutical Companies; (3) to facilitate communications among the PPRUs, the FDA, and Industry (Pharmaceutical Companies and Contract Research Organizations); (4) to ensure that pediatric clinical trials are performed in a cost-effective and time-expedient manner; (5) to develop and maintain information systems for specified tasks; and (6) to monitor performance measured by specified parameters. The Central Office performs the following tasks: (1) Development and maintenance of a clinical trial data management system; (2) Development and maintenance of information system for the tracking and status for the acquisition, start-up, progress, completion, reports, summaries and labeling status of all drugs involved in PPRU studies; (3) Development of standard procedures manuals for data management; (4) Analysis and generation of reports as required by the FDA and pharmaceutical companies and development of an audit trail; (5) Analysis and generation of annual and customized reports; (6) Formulation of an adverse experience reporting system; (7) Development of standardized contract with pharmaceutical firms for all units; (8) Provide assistance in the negotiation and management of contracts with industry; (9) Assessment of current and future needs of the Network and assessment of growth, including fiscal and business projections; (10) Maintenance of compliance assessments, enrollment performance, and success rates of individual units; (11) Development of procedures to standardize site monitoring; and (12) Preparation and maintenance of all operating documents, policies, and procedures of the PPRU Network.