PEDIATRIC PHARMACOLOGY RESEARCH UNITS
PEDIATRIC PHARMACOLOGY RESEARCH UNITS
批准号:
6365920
负责人:
Selma C Kunitz
金额:
$34.59万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-09-30 至 2003-09-29
中文摘要
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
(7)与制药公司订立标准化合同
(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.
英文摘要
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.
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PEDIATRIC PHARMACOLOGY RESEARCH UNITS
-
批准号:6143192
-
项目类别:
-
资助金额:$38.39万
-
财政年份:1998
-
负责人:Selma C Kunitz
-
依托单位:
PEDIATRIC PHARMACOLOGY RESEARCH UNITS
-
批准号:2878114
-
项目类别:
-
资助金额:$30.61万
-
财政年份:1998
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:2860267
-
项目类别:
-
资助金额:$15.67万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:2901767
-
项目类别:
-
资助金额:$0.0万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:6358795
-
项目类别:
-
资助金额:$9.72万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:2839518
-
项目类别:
-
资助金额:$0.0万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:2298489
-
项目类别:
-
资助金额:$19.44万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:2649686
-
项目类别:
-
资助金额:$15.18万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
DATA INTEGRITY ASSESSMENTS FOR NIAMS CLINICAL TRIALS
-
批准号:6155160
-
项目类别:
-
资助金额:$20.59万
-
财政年份:1996
-
负责人:Selma C Kunitz
-
依托单位:
海外基金