PEDIATRIC PHARMACOLOGY RESEARCH UNITS

儿科药理学研究单位

• 批准号: 2878114
• 负责人: Selma C Kunitz
• 金额: $ 30.61万
• 依托单位: KAI RESEARCH, INC
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2003-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2878114
• 关键词: chemical information system; clinical trials; computer system design /evaluation; data management; governmental health /scientific organization; health care cost /financing; health system agency; industry; information systems; pediatric pharmacology

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.

中央运营和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） 促进PPRU、FDA和行业之间的沟通 （制药公司和合同研究组织）;（4） 确保儿科临床试验以具有成本效益的方式进行 （5）开发和维护信息系统 （6）监督由指定任务衡量的绩效 参数 中央办公室执行以下任务：（1）发展和 临床试验数据管理系统的维护;（2）开发 信息系统的跟踪和维护， 采购、启动、进度、完成、报告、总结和 参与PPRU研究的所有药物的标签状态;（3） 数据管理的标准程序手册;（4）分析和 生成FDA和制药公司要求的报告 （5）分析和生成年度报告; 和定制报告;（6）制定不良事件报告 系统;（7）与制药公司制定标准化合同 （8）协助谈判和管理 （9）评估目前和未来的需求， 网络和增长评估，包括财政和商业 （10）维持合规性评估、招募 （11）发展中国家， 标准化工地监察程序;及（12）准备及 维护所有运营文件、政策和程序， Network.