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: 7970204
• 负责人: Caryn Steakley
• 金额: $ 441.03万
• 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/7970204
• 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 临床研究活动与书面方案、机构和 法规要求，数据完整、及时且可验证。有三个关键 构成数据管理计划结构的组件; 1）数据管理; 2） 监测/审计; 3）信息学，开发和实施中央档案室内的数据库 与临床研究有关。这三个领域都需要提供服务，以支持 CCR研究者的临床研究工作。数据管理承包商作为 CCR的临床研究组织。我们的临床试验数据 转化为更好的病人护理，提高生活质量，以及新药开发， 癌症患者。这些信息随后被发表在重要的专业期刊上 影响社区的临床实践。