Clinical Research Support Services

临床研究支持服务

基本信息

批准号：
8602500
负责人：
RICHARD COHN
金额：
$ 956.13万
依托单位：
SYSTEMS RESEARCH AND APPLICATION CORP.
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-30 至 2015-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8602500
关键词：
Adverse effects Advertisements Biochemical Biological Biological Products Blood Chemicals Clinical Clinical Research Collaborations Complex Consent Forms Contractor Contracts Data Data Collection Databases Development Diagnosis Diagnostic Diagnostic Procedure Diet Disease Electronics Enrollment Environmental Exposure Environmental Risk Factor Genetic Predisposition to Disease Government Health Insurance Portability and Accountability Act Healthcare Human Institutional Review Boards Interview Intramural Research Laboratories Laboratory Finding Life Style Manuals Manuscripts Medical Molecular Monitor National Institute of Environmental Health Sciences Operative Surgical Procedures Outpatients Pamphlets Patient Care Patients Pharmaceutical Preparations Population Principal Investigator Protocols documentation Questionnaires Radiation Records Recruitment Activity Reporting Research Research Design Research Support Role Sample Size Sampling Scientist Services Shipping Ships Study Subject Technical Expertise Techniques Telephone Testing Therapeutic Translating Translations Update Urine Validation Work abstracting base case history clinical application data management design foreign language human tissue instrument operation programs research clinical testing research study trait web site

项目摘要

The Clinical Research Program (CRP) conducts or oversees clinical research studies within the Division of Intramural Research (DIR), National Institute of Environmental Health Sciences (NIEHS). The objectives of these studies are to: 1) translate basic laboratory findings to clinical applications; 2) investigate the interaction between genetic susceptibility and environmental factors as they relate to complex traits and disease in human populations; and 3) intervene in disease development and/or progression by modifying these factors using preventative, therapeutic, surgical, radiation and other techniques, or by altering environmental exposures, diet and lifestyles. The purpose of this contract is to provide medical, diagnostic, therapeutic, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators (PIs) within the DIR, NIEHS and their collaborators. The Contractor shall assist the Government by identifying and enrolling subjects, and administering, managing, and conducting clinical studies designed and supervised by PIs alone or in collaboration with other scientists inside or outside of the NIEHS. Another purpose of this contract is to provide technical expertise and health care staff to the NIEHS Clinical Research Unit (CRU) in support of clinical studies conducted in that facility. The Contractor shall function in a purely supportive role carrying out specific work assignments, and shall not engage in independent research.

临床研究计划（CRP）在国家环境健康科学研究所（NIEHS）内进行或监督壁内研究（DIR）内的临床研究。这些研究的目标是：1）将基本实验室发现转化为临床应用； 2）研究遗传易感性与环境因素之间与人口中复杂性状和疾病有关的环境因素之间的相互作用； 3）通过使用预防，治疗，手术，辐射和其他技术修改这些因素，或通过改变环境暴露，饮食和生活方式来修改这些因素，从而干预疾病的发展和/或进展。该合同的目的是为DIR，NIEHS及其合作者内的主要研究人员（PIS）提供医学，诊断，科学，技术，数据管理，管理，文书和统计支持。承包商应通过识别和注册受试者，管理和进行由PIS设计和监督的临床研究或与NIEHS内部或外部的其他科学家合作，通过识别和注册受试者，管理和进行临床研究来协助政府。该合同的另一个目的是向NIEHS临床研究部（CRU）提供技术专长和卫生保健人员，以支持该设施中进行的临床研究。承包商应在执行特定工作任务的纯粹支持角色中发挥作用，并且不得参与独立研究。