NHLBI-DE-08-16Clinical Research Operations and Management Support (CROMS)

NHLBI-DE-08-16临床研究运营和管理支持 (CROMS)

• 批准号: 8760352
• 负责人: NANCY YOVETICH
• 金额: $ 457.17万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2014-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8760352
• 关键词: Behavioral; Clinical; Clinical Research; Clinical Trials; Contractor; Contracts; Data Analyses; Disease; Epidemiology; Evaluation; Extramural Activities; Funding; Incidence; Intramural Research; Intramural Research Program; Mission; Mouth Diseases; Multi-Institutional Clinical Trial; National Heart, Lung, and Blood Institute; National Institute of Dental and Craniofacial Research; Natural History; Operations Research; Phase; Prevalence; Prevention; Preventive; Procedures; Protocols documentation; Research; Research Contracts; Research Design; Research Project Grants; Research Support; Resources; Role; Services; Site; Therapeutic; Tooth Diseases; clinical research site; craniofacial; data management; operation; population based; programs; sound; tool

The purpose of this new contract requirement is to provide comprehensive clinical research operations support, management and data coordinating services for clinical research sponsored by NIDCR's extramural and intramural research divisions. The contract will provide NIDCR with clinical research management support and oversight tools to assist in the effective administration and coordination of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study design, study execution, data management and analysis, and regulatory compliance. Specific tasks performed will vary by clinical study and clinical site, and will be dependent on the study's protocol, standard operating procedures, and the roles/duties assigned to the Contractor by the NIDCR Project Officer.

这一新合同要求的目的是为NIDCR的校外和校内研究部门赞助的临床研究提供全面的临床研究运营支持、管理和数据协调服务。该合同将为NIDCR提供临床研究管理支持和监督工具，以协助其临床研究计划的有效管理和协调。此外，它还将提供辅助专业知识和资源，以确保合理有效的临床研究设计、研究 执行、数据管理和分析以及法规遵从性。所执行的具体任务将因临床研究和临床研究中心而异，并将取决于研究方案、标准操作规程以及承包商分配给承包商的角色/职责。 NIDCR项目官员。