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Subject & Protocol Registry

This module functions in two key ways. First, it improves study protocol management. It facilitates collaboration among groups of researchers as they develop study protocols. It provides a central location for study documents and a directory for study personnel. By interfacing with eIRB systems, it automatically creates applications for new studies and tracks IRB and other regulatory dates. The system manages IRB submissions and approvals of multiple IRBs, and allows role-based access to key regulatory and financial information.

Second, it provides accurate, one-click access to critical subject information. It tracks subjects’ consent, eligibility, insurance clearance, and enrollment status, as well as demographic and contact information. An automated messaging system notifies study team members, pharmacy, billing staff and others of important subject events. The result is decreased staff time spent managing and tracking subjects.

Key Benefits:

  • Track protocol (study) information and status
  • Document, Consent, and Eligibility Management
  • IND/IDE tracking
  • Regulatory Compliance
  • Multi-site management (internal vs external sites)
  • Track patient (subject) information
  • Manage Accruals and Enrollments
  • Know which patients are study subjects