The Indiana University Simon Cancer Center (IUSCC) has a robust clinical trials program. In the year 2006, 635 patients were enrolled on therapeutic protocols at the IUSCC and managed by the IUSCC Clinical Research Office (CRO). Additionally, there were 969 patients enrolled on correlative and ancillary studies. The IU Simon Center CRO is a shared resource available to all clinical investigators of the Cancer Center. The CRO provides central management and oversight functions for all phases of cancer clinical trials at IUSCC. With the aid of the "On-line Clinical Oncology Research Environment" (Oncore) database, this resource provides a central location for cancer protocols, centralized database of protocol-specific data, list of currently active protocols, and status reports of protocols. The CRO also manages the "mapping" of available trials for each disease site. Moreover, as part of this shared resource, the CRO educates and trains data managers and nurses and it conducts audits to assure the highest quality of clinical research data. Support from the CCSG is requested for the following functions of the CRO: training and supervision of research staff, maintenance of computerized databases to track protocols and patient data, various quality assurance activities, and interaction and data transfer with the Biostatistics Core. In summary, the CRO provides comprehensive essential services that enable the clinical investigator to efficiently conduct trials. These services begin in the early stages of protocol development and continue throughout scientific review and study implementation, publication, and long-term follow-up. The Biostatistics and Data Management shared facility is integrated with the CRO to ensure appropriate analysis of data and to facilitate quality assurance monitoring.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA082709-14S3
Application #
8637210
Study Section
Subcommittee G - Education (NCI)
Project Start
1999-09-22
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
14
Fiscal Year
2013
Total Cost
$82,641
Indirect Cost
$29,666
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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