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Last Updated: 02/12/16

NCI ETCTN Program Infrastructure

Graphic representing 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.