TAS::75 0850::TAS RECOVERY ACT ACTNOW CLINICAL TRIAL SUPPORT - CTEP IT Support

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Cancer Therapy Evaluation Programs Informatics and Computer Support of Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW). The Division of Cancer Treatment and Diagnosis (DCTD), primarily through its Cancer Therapy Evaluation Program (CTEP), sponsors several unique mechanisms to carry out early anticancer therapy development. The mechanisms encompass many of the nation's leading NCI-designated Comprehensive Cancer Centers, NCI's Cooperative Group programs in adult and pediatric oncology with participating sites in every state, and specialized Oncology Consortia devoted to the study of brain and childhood cancers. The Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program is focused on accelerating progress by speeding the development of approximately 30 new clinical treatment trials. The accelerated timeline is possible due to the resources provided by ARRA. ARRA funds will assist NCI staff in supporting the accelerated timeline for mounting these 30 clinical trials. Funds will be added to CTEP support contracts including the Cancer Therapy and Evaluation Program's Informatics and Computer Support Contract. The Cancer Therapy Evaluation Program's Enterprise System (CTEP ESYS) is made up of 22 modules At the present time these modules include but are not limited to: Clinical Trials Monitoring Branch Audit Information System (CTMB-AIS), Protocol Authorization and Tracking System (PATS), Drug Authorization and Review Tracking System (DARTS), Clinical Data Update System (CDUS), Web Enabled CDUS, Common Toxicity Criteria Interactive Tool (CTCAE), Adverse Drug Experience Electronic Reporting Systems (AdEERS), Enterprise Query Wizard (EQW), Financial Instrument and Accrual Tracking System (FIATS), CTEP Account Management System (AMS), Clinical Investigations Branch Information System and Clinical IT (CIBISCIT), Regulatory Affairs Branch Information Tracking System (RABITS), Document Management, Assembly, Review and Tracking System (Docu-MART), and the CTEP Web Page. The primary objectives of the CTEP Enterprise System are to: ¿ Capture data and translate it into a usable format to address the scientific, safety, regulatory and administrative needs of CTEP and the NCI. ¿ Eliminate data redundancy throughout the oncology community ¿ Streamline clinical research operations. ¿ Reduce the administrative burden on NCI staff, contractors, and extramural researchers. ¿ Improve communication between CTEP and its collaborators. ¿ Assure the security and confidentiality of proprietary and patient information. ¿ Increase access to clinical trials to all investigators ¿ Capitalize on XML and other technologies to maximize reusability and integration with other systems in the oncology community. ¿ Support broad patient access to clinical trials. ¿ Expedite the protocol development and review process within both clinical trial organizations and reviewing bodies