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PODS - LORAZEPAM - STATUS EPILEPTICUS, BEST PHARMACEUTICAL FOR CHILDREN ACT

PODS - 劳拉西泮 - 癫痫持续状态，最佳儿童药物法案

基本信息

批准号：
8328333
负责人：
JAMES CHAMBERLAIN
金额：
$ 21.44万
依托单位：
CHILDREN'S RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-30 至 2011-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8328333
关键词：
Adherence Adverse event Best Pharmaceuticals for Children Act Child Childhood Clinical Clinical Practice Guideline Clinical Trials Clinical Trials Data Monitoring Committees Communication Contracts Data Data Analyses Data Quality Data Reporting Databases Documentation Drug usage Enrollment Ensure Ethics Failure Funding Good Clinical Practice Guidelines Information Systems Information Technology Institutional Review Boards International Label Legal patent Lorazepam Measures Monitor National Institute of Child Health and Human Development Notification Participant Patients Peer Review Performance Pharmaceutical Preparations Pharmacology Pharmacy facility Preparation Protocols documentation Publications Publishing Reporting Research Research Infrastructure Resources Safety Site Social Welfare Specific qualifier value Status Epilepticus System TimeLine Toxicology United States National Institutes of Health base design meetings operation pre-clinical programs symposium

项目摘要

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.

NICHD 受 NIH 委托，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 负责对用于儿童但缺乏足够儿科标签的优先“非专利”药物进行临床试验。 NICHD 的职责包括行政活动以及支持、协调其他 IC 的支持和参与 BPCA 活动。该合同的目的是建立和支持协调 BPCA 儿科临床试验的基础设施。该 DCC 的职能是提供监管、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进行药理学研究的多站点临床中心网络。