PODS - LORAZEPAM - STATUS EPILEPTICUS, BEST PHARMACEUTICAL FOR CHILDREN ACT
PODS - LORAZEPAM - STATUS EPILEPTICUS, BEST PHARMACEUTICAL FOR CHILDREN ACT
批准号:
8328333
负责人:
JAMES CHAMBERLAIN
金额:
$21.44万
依托单位国家:
美国
项目类别:
财政年份:
2004
资助国家:
美国
项目状态:
已结题
起止时间:
2004-09-30 至 2011-08-31
关键词:
AdherenceAdverse eventBest Pharmaceuticals for Children ActChildChildhoodClinicalClinical Practice GuidelineClinical TrialsClinical Trials Data Monitoring CommitteesCommunicationContractsDataData AnalysesData QualityData ReportingDatabasesDocumentationDrug usageEnrollmentEnsureEthicsFailureFundingGood Clinical PracticeGuidelinesInformation SystemsInformation TechnologyInstitutional Review BoardsInternationalLabelLegal patentLorazepamMeasuresMonitorNational Institute of Child Health and Human DevelopmentNotificationParticipantPatientsPeer ReviewPerformancePharmaceutical PreparationsPharmacologyPharmacy facilityPreparationProtocols documentationPublicationsPublishingReportingResearchResearch InfrastructureResourcesSafetySiteSocial WelfareSpecific qualifier valueStatus EpilepticusSystemTimeLineToxicologyUnited States National Institutes of Healthbasedesignmeetingsoperationpre-clinicalprogramssymposium
中文摘要
NICHD由NIH授权,负责实施国会授权的2002年儿童最佳药物法案,并于2007年重新授权。NICHD负责进行优先临床试验,即用于儿童但缺乏足够儿科标签的非专利药物。国家排雷中心的职责包括行政活动以及支持、协调支持和其他国际中心参与BPCA活动。该合同的目的是建立和支持基础设施,以协调BPCA儿科临床试验。本DCC的职能是提供法规、技术(包括统计和信息技术)、行政和后勤支持,以维护、协调和管理将在儿童中开展药理学研究的多中心临床中心网络。
英文摘要
The NICHD, as delegated by the NIH, is responsible for implementing the Congressionally-mandated Best Pharmaceuticals for Children Act of 2002, as reauthorized in 2007. The NICHD is responsible for the performance of clinical trials of priority, ¿off patent¿ drugs that are used in children but that lack sufficient pediatric labeling. NICHD responsibility includes administrative activities as well as support, and coordinating support and participation of other ICs in BPCA activities. The purpose of the contract is to establish and support an infrastructure for the coordination of the BPCA pediatric clinical trials. The function of this DCC is to provide regulatory, technical (including statistical and information technology), administrative and logistical support to maintain, coordinate and manage a multi-site network of clinical centers which will conduct pharmacology studies in children.
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Secure Interactive Telemedicine Via State-wide Internet
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批准号:6583362
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项目类别:
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资助金额:$10.0万
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财政年份:2003
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负责人:JAMES CHAMBERLAIN
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依托单位:
海外基金