NCI ETCTN Program Infrastructure

1. CTEP-Identity and Access Management (CTEP-IAM)
   • Investigators and Associates register for an account that enables access to the other applications (CTSU, OPEN/IWRS, Rave, CTEP Enterprise).
2. Cancer Trials Support Unit (CTSU)
   • Provides a variety of services, including institution and person roster support; website support for posting of protocols and other information; and links to other services (OPEN/IWRS, Rave).
3. NCI Central Institutional Review Board (CIRB)
   • Conducts IRB review of most early-phase NCI-sponsored trials, including ETCTN studies.
4. Oncology Patient Enrollment Network (OPEN)/Interactive Web Response System (IWRS)
   • Linked applications for patient enrollment (OPEN) and slot reservations and cohort management (IWRS). Data will be automatically transferred to Rave.
5. Medidata Rave
   • An application for data entry, data analysis, and clinical trial management.
6. CTEP Enterprise System
   • An application for integrated clinical trials management and reporting, including Serious Adverse Event (SAE) reporting through the CTEP-Adverse Event Reporting System (CTEP-AERS); ordering of investigational agents; trial monitoring/audits; and Operational Efficiency Working Group (OEWG) reporting.
7. Regulatory Support Services (RSS)
   • Serves as a centralized repository for the regulatory documents for all NCI-supported multi-center clinical trials. The RSS provides a streamlined and comprehensive approach to collecting and maintaining site registration, person, and institution documentation essential to the management of clinical trials.