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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA079778-14S1
Application #
8640252
Study Section
Special Emphasis Panel (ZCA1-SRRB-9 (O1))
Program Officer
Henderson, Lori A
Project Start
1999-03-01
Project End
2013-12-31
Budget Start
2013-01-01
Budget End
2013-12-31
Support Year
14
Fiscal Year
2013
Total Cost
$2,271,308
Indirect Cost
$814,183
Name
Brown University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
001785542
City
Providence
State
RI
Country
United States
Zip Code
02912
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