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Clinical Research Support Services for NIEHS Contract

Clinical Research Support Services for NIEHS Contract
NIEHS 合同临床研究支持服务
批准号：
9369084
负责人：
DAVID WAGNER
金额：
$17.53万
依托单位：
SOCIAL AND SCIENTIFIC SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
项目状态：
已结题
起止时间：
2016-06-18 至 2017-06-17
来源：
https://reporter.nih.gov/project-details/9369084
关键词：
Clinical ResearchClinical TrialsConsent FormsContractorContractsDevelopmentElectronicsInstitutional Review BoardsNational Institute of Environmental Health SciencesPrincipal InvestigatorProceduresProtocols documentationQuality ControlRecruitment ActivityReportingResearchResearch SupportResourcesServicesStatistical Data InterpretationWorkoperationprotocol developmentquality assurance

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中文摘要
翻译
本可分割任务订单的目的是提供方案开发和协调。 具体而言，要求承包商执行与制定监管/FDA文件相关的任务。 承包者将为主要调查员和任务负责人开展背景工作，以进一步制定和确定方案。承包者将制定研究协议，包括必要的统计分析，制定同意书，并协助制定电子记录协议。承包商将准备必要的文件提交给NIEHS IRB。
英文摘要
The purpose of this severable task order is to provide protocol development and coordination. Specifically, the contractor is required to perform tasks associated with the development of regulatory/FDA documents. The contractor will conduct the background work for principal investigators and task leaders for further protocol development and identification. The contractor will develop research protocols including statistical analysis as necessary, development of consent forms and assistance with development of electronic record protocols. The contractor will prepare of necessary documents for submission to NIEHS IRB.
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