CC: Clinical Trials Core

CC：临床试验核心

基本信息

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
项目类别：
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

项目摘要

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。