Protocol Specific Research Support

协议特定研究支持

• 批准号: 8350790
• 负责人: GEROLD BEPLER
• 金额: $ 1.49万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-06 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8350790
• 关键词: Basic Science; Biostatistics Core; Businesses; Calendar; Case Report Form; Clinic; Clinical Research; Clinical Research Protocols; Clinical Trials; Data; Data Analyses; Development; Electronics; Fostering; Funding; Instruction; Laboratories; Peer Review; Phase; Phase I Clinical Trials; Protocols documentation; Research Personnel; Research Support; Services; data management; innovation; protocol development

The Protocol Specific Research Support (PSRS) provides funding for innovative, short term, feasibility and phase I clinical trials originating from scientific investigators within KCI. The primary objective is to foster investigator-initiated trials that bring new results from the basic science laboratories to KCI's clinics. PSRS provides funding to encourage expansion of the number of investigator-initiated protocols and the development of innovative trials that may have insufficient preliminary data to be competifive for peer reviewed funding. The Clinical Research Coordinator (CRC) and Business Analyst funded by PSRS provide data management and study coordination in support of high priority, innovative, feasibility and phase I invesfigator-inifiated clinical research protocols. The services provided by the CRC are in accordance with the services of the Clinical Trials Office Core (Secfion 9.1.10). The Business Analyst creates protocol specific calendars and electronic case report forms (eCRFs) within OnCore¿. The information captured in the eCRF is used by the Biostatistics Core for protocol data analysis.

方案特定研究支持（PSRS）为创新性、短期、可行性研究提供资金。 以及KCI内部科学研究人员发起的I期临床试验。主要目的是 促进制药商发起的试验，将基础科学实验室的新结果带到KCI的诊所。 PSRS提供资金，以鼓励扩大由制药商发起的协议的数量， 开发可能没有足够的初步数据与同行竞争的创新试验 审查资金。 由PSRS资助的临床研究协调员（CRC）和业务分析师提供数据 管理和研究协调，以支持高优先级、创新性、可行性和第一阶段 投资者发起的临床研究方案。CRC提供的服务符合 临床试验办公室核心的服务（第9.1.10节）。业务分析师创建协议 OnCore中的特定日历和电子病例报告表（eCRF）。信息获取于 生物统计学核心使用eCRF进行方案数据分析。