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.

协议特定研究支持（PSRS）为创新，短期，可行性提供资金 和I期临床试验，起源于KCI内的科学研究者。主要目标是 促进研究员发起的试验，将基础科学实验室的新结果带到KCI的诊所。 PSR提供资金，以鼓励扩大研究者发起的协议的数量和 开发创新试验可能没有足够的初步数据而无法竞争同伴的创新试验 审查资金。 PSR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，可行性和I期 研究者影响的临床研究方案。 CRC提供的服务符合 临床试验办公室核心的服务（Secfion 9.1.10）。业务分析师创建协议 特定日历和电子案例报告表（ECRFS）。捕获的信息 生物统计学核心将ECRF用于协议数据分析。