Regulatory Support for Cancer Prevention Agent Development

癌症预防剂开发的监管支持

• 批准号: 8930897
• 负责人: CAROLINE C SIGMAN
• 金额: $ 207.04万
• 依托单位: CCS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2015-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8930897
• 关键词: Adverse event; Agreement; Amendment; Area; Chemoprevention; Clinical; Clinical Data; Clinical Research; Clinical Trials; Contractor; Contracts; Cooperative Research and Development Agreement; Data; Development; Disclosure; Division of Cancer Prevention; Documentation; Electronics; Information Management; Laws; Maintenance; Malignant Neoplasms; Management Information Systems; National Cancer Institute; Paper; Pharmacologic Substance; Prevention Protocols; Prevention program; Preventive; Procedures; Process; Protocols documentation; Records; Regulation; Regulatory Affairs; Reporting; Research; Research Personnel; Safety; Schedule; Services; United States Food and Drug Administration; cancer prevention; material transfer agreement; meetings; pre-clinical; programs; research and development

The purpose of this contract is to provide regulatory services and technical support to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). This contract will prepare and maintain documents required by the Food and Drug Administration (FDA) and other regulatory bodies for clinical trials of investigational agents. Technical Support is required to gather, interpret and summarize the preclinical and clinical data associated with potential cancer preventive agents.

该合同的目的是为国家癌症研究所（NCI）的癌症预防措施（DCP）提供监管服务和技术支持。该合同将准备并维护食品药品监督管理局（FDA）和其他监管机构所需的文件，以进行研究代理的临床试验。需要技术支持来收集，解释和总结与潜在癌症预防剂相关的临床前和临床数据。