Center for Cancer Research Clinical Trials Data Management Service

癌症研究中心临床试验数据管理服务

• 批准号: 9154369
• 负责人: Caryn Steakley
• 金额: $ 279.27万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9154369
• 关键词: Area; CCR; Clinical Investigator; Clinical Research; Clinical Research Protocols; Clinical Trials; Communities; Contractor; Contracts; Data; Databases; Development; Ensure; Guidelines; Informatics; Journals; Malignant Neoplasms; Mission; Monitor; NCI Center for Cancer Research; Patient Care; Patients; Protocols documentation; Publications; Publishing; Quality of life; Research; Research Activity; Research Personnel; Research Support; Services; Structure; Translating; Writing; clinical practice; data management; drug development; high standard; improved; meetings; protocol development

The data management team supports the research team in activities which ensure all clinical research activities are consistent with the written protocol, institutional and regulatory requirements, and data is complete, timely, and verifiable. There are three key components that form the structure for the data management plan; 1) data management; 2) monitoring/auditing; 3) informatics, development and implementation of databases within CCR relating to clinical research. All three areas are needed to provide services to support the clinical research effort for CCR investigators. The data management contractor acts as a Clinical Research Organization for the CCR. The data generated from our clinical trials translate into better patient care, improved quality of life, and new drug development for patients with cancer. This information is then published in important professional journals that impact clinical practices in the community.

数据管理团队支持研究团队的活动，确保所有临床研究活动符合书面方案、机构和监管要求，并且数据完整、及时且可验证。数据管理计划的结构由三个关键组成部分组成； 1）数据管理； 2）监控/审计； 3) CCR 内与临床研究相关的数据库的信息学、开发和实施。所有三个领域都需要提供服务来支持 CCR 研究人员的临床研究工作。数据管理承包商充当 CCR 的临床研究组织。我们的临床试验产生的数据可以转化为更好的患者护理、改善的生活质量以及癌症患者的新药开发。然后，这些信息将发表在影响社区临床实践的重要专业期刊上。