Biostatistics Data Management Center for ACRIN

ACRIN 生物统计数据管理中心

• 批准号: 7896184
• 负责人: CONSTANTINE A. GATSONIS
• 金额: $ 109.54万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-03-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7896184
• 关键词: Address; American College of Radiology; American College of Radiology Imaging Network; Award; Biometry; Clinical Research; Common Data Element; Confidentiality; Data; Data Analyses; Data Collection; Data Quality; Databases; Development; Diagnostic Imaging; Ensure; Evaluation; Funding; Human Resources; Image; Leadership; Manuscripts; Monitor; Operative Surgical Procedures; Performance; Philadelphia; Procedures; Protocol Compliance; Protocols documentation; Regulation; Reporting; Research; Research Design; Research Personnel; Role; Science; Site; Statistical Methods; Universities; Work; data management; design; economic outcome; high standard; human subject protection; statistical center

DESCRIPTION (provided by applicant): This proposal responds to RFA-CA-07-505 "The American College of Radiology Imaging Network" and addresses the needs of ACRIN's Biostatistics and Data Management Center (BDMC). This proposal is submitted in coordination with a proposal from the Headquarters of ACRIN. Should the funding be awarded, the BDMC of ACRIN will continue to be operated jointly by the Center for Statistical Sciences, Brown University and the American College of Radiology. The main responsibility for data collection and management is with the Philadelphia office of the ACR. The overall direction of the BDMC and the main responsibility for study design, monitoring, and data analysis, is with Brown. Key aspects of the BDMC operation will be the following: 1. To provide support and methodologic leadership to ACRIN investigators in the design, development and implementation of network studies. 2. To work with protocol teams on the design and implementation of data collection forms and procedures. 3. To carry out protocol data collection and to develop and maintain a primary database at the Data Management Center and to ensure efficient and accurate access to the database by Biostatistics Center personnel for study monitoring and analysis. 4. To continually monitor and verify the quality of the data, including checks of accuracy, completeness, and timeliness. To implement procedures designed to guarantee the integrity of the database. 5. To continually monitor and verify protocol compliance and to support participating sites in achieving high standards of performance. To provide methodologic expertise for site audits. 6. To design and perform interim and final analyses and to generate relevant reports. To provide methodologic leadership and support in summarizing study findings and preparing manuscripts. 7. To address methodologic issues arising in the design and analysis of ACRIN studies and to carry out research on statistical methods for the evaluation of diagnostic imaging. 8. To work with investigators and research entities requesting access to ACRIN data and to facilitate the maximum, proper use of scientific information from ACRIN studies. To collaborate in the development of common data elements for imaging clinical studies. 9. To operate and further develop a reliable, nimble, and effective organization, with clearly defined roles and objectives, a well articulated set of Standard Operating Procedures and federal regulation compliance concerning data confidentiality and human subject protection. 10. To organize, facilitate and support outcomes and economics research in ACRIN studies.

描述（由申请人提供）：该提案对RFA-CA-07-505做出了回应，“美国放射学成像网络”，并满足了Acrin Biostatistics and Data Management Center（BDMC）的需求。该提案与Acrin总部的提案协调。如果授予资金，ACRIN的BDMC将继续由统计科学中心，布朗大学和美国放射学院共同运营。数据收集和管理的主要责任是ACR的费城办公室。 BROWN的BDMC的总体方向以及研究设计，监视和数据分析的主要责任。 BDMC操作的关键方面将包括以下内容： 1。在网络研究的设计，开发和实施中为Acrin研究人员提供支持和方法论领导。 2。与协议团队一起进行数据收集表和过程的设计和实施。 3。进行协议数据收集并在数据中开发和维护主要数据库 管理中心，并确保通过生物统计学中心人员有效，准确地访问数据库，以进行研究监测和分析。 4。不断监视和验证数据的质量，包括准确性，完整性和及时性的检查。实施旨在保证数据库完整性的过程。 5。不断监视和验证协议合规性并支持达到高标准的参与站点。为现场审核提供方法论专业知识。 6。设计和执行临时和最终分析并生成相关报告。提供 方法论的领导力和支持总结研究结果和准备手稿。 7。解决Acrin研究的设计和分析中引起的方法论问题并进行 用于评估诊断成像的统计方法的研究。 8。与要求访问ACRIN数据的调查人员和研究实体合作，并促进Acrin研究中最大程度地使用科学信息。在开发成像临床研究的常见数据元素方面合作。 9。要运营并进一步发展一个具有明确定义的角色和目标的可靠，敏捷且有效的组织，一套明确的标准操作程序集以及有关数据机密性和人类主题保护的联邦法规合规性。 10。在Acrin研究中组织，促进和支持结果和经济学研究。