CC: Clinical Trials Core

CC：临床试验核心

• 批准号: 7507437
• 负责人: JONATHAN W FRIEDBERG
• 金额: $ 23.54万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7507437
• 关键词: Adverse event; Area; Arizona; Biostatistics Core; Biotechnology; Cancer Center; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Committee Members; Communication; Consensus; Consent; Data; Data Collection; Data Reporting; Databases; Development; Diagnostic; Discipline; Discipline of Nursing; Disputes; Drug Kinetics; End Point; Enrollment; Epidemiology; Group Structure; Human Resources; Image; Industry; Institution; Investigation; Laboratories; Lymphoma; Molecular; Monitor; Operative Surgical Procedures; Patients; Persons; Pharmacologic Substance; Pharmacology; Population; Preparation; Program Development; Protocols documentation; Regulation; Reproduction spores; Research Ethics Committees; Research Project Grants; Resolution; Resource Sharing; Resources; Running; Safety; Schedule; Source; Southwest Oncology Group; Specimen; Teleconferences; Therapeutic Agents; Tissue Banks; Translations; Tumor Biology; United States Food and Drug Administration; Universities; Work; Writing; base; career; concept; data management; member; multidisciplinary; novel; novel therapeutics; programs; sample collection; statistics

Core C : Clinical Trials The primary objective of the clinical trials core is to provide assistance to the projects in all aspects of clinical trial design, implementation, regulation, data collection, and interpretation, pharmacokinetics, and other specimen collections for targeted therapy investigations and/or banking. Specifically, the clinical trials core facilitates protocol writing and preparation, submission, and regulatory review, interacting directly with the NCI, FDA, Industry sponsors and IRB as needed. The clinical trials core maintains the database and all aspects of data management for patients enrolled on clinical trials within the SPORE. Adverse event reporting and data and safety monitoring for all protocols on the SPORE application are coordinated through the clinical trials core. The clinical trials core seamlessly interacts with the specimen core, providing clinical, epidemiologic and demographic data on patients consenting to tissue banking, and with the biostatistics core, providing timely reports and data for analysis.

核心 C：临床试验 临床试验核心的主要目标是为项目提供临床各方面的帮助 试验设计、实施、监管、数据收集和解释、药代动力学等 用于靶向治疗研究和/或储存的标本收集。具体来说，临床试验的核心 促进方案的编写和准备、提交和监管审查，直接与 根据需要，NCI、FDA、行业赞助商和 IRB。临床试验核心维护数据库和所有 SPORE 内参加临床试验的患者的数据管理方面。不良事件 SPORE 应用程序所有协议的报告、数据和安全监控通过以下方式协调： 临床试验核心。临床试验核心与样本核心无缝交互，提供临床、 同意组织库的患者的流行病学和人口统计数据以及生物统计学 核心，提供及时的报告和数据进行分析。