Clinical Research Operations and Management Support (CROMS)

临床研究运营和管理支持 (CROMS)

• 批准号: 10918011
• 负责人: NANCY YOVETICH
• 金额: $ 377.42万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10918011
• 关键词: Adverse event; Clinical; Clinical Research; Clinical Trials; Collaborations; Collection; Computers; Consult; Contractor; Contracts; Data; Data Analyses; Data Collection; Data Reporting; Development; Devices; Extramural Activities; Human Resources; Intramural Research; Investigational Drugs; Investigational New Drug Application; Knowledge; Laboratory Research; Management Information Systems; Monitor; National Institute of Dental and Craniofacial Research; Operations Research; Phase; Preparation; Procedures; Protocols documentation; Quality Control; Reporting; Research; Research Design; Research Personnel; Resources; Role; Safety; Secure; Serious Adverse Event; Services; Site; Statistical Data Interpretation; System; Training; Update; Work; central database; clinical research site; data management; design; experience; pharmacovigilance; programs; protocol development; research study; sound; tool; web site

The purpose of this contract 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 Contracting Officer’s Representative (COR).

该合同的目的是为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，以确保合理和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。执行的具体任务将因临床研究和临床现场而异，并将取决于研究方案、标准操作程序以及NIDCR合同官员代表(COR)分配给承包商的角色/职责。