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Why CTDB?

CAPABILITIES:

  • Single-site and multi-site protocol set-up
  • Cross-protocol data extraction
  • Data access rules
  • Common data elements
  • Data integrity processes
  • Adverse event reporting and data-based, email-alert triggers
  • Study subject self-reporting - Clinical Trials Survey System (CTSS)
  • Globally Unique Identification (GUID) generator

SECURITY:

  • Vetted by NIH ISOs (Information Security Officers)
  • Secure HTTP(S) user interface enables DIACAP and FISMA compliance
  • Procedures for protecting subject's PII
  • PI-assigned data access privileges to administrative users, clinicians, researchers, protocol auditors, etc.
  • Double-key data entry with third-party data reconciliation
  • 21 CFR 11 compliant

DATA ARCHITECTURE:

  • Re-usable libraries of questions, scales, data-collection forms
  • Customizable form design
  • Codebook and data export
  • Paper form export
  • Validated rehabilitation scales and measures
  • Data validation and integrity processing
  • Document repository
  • Biospecimen/Device tracking
  • E-Regulatory document repository