Cancer Therapy Evaluation Programs 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
