GCP Tracker

GCP Tracker is a management platform for Clinical Research Organizations (CROs) to maintain oversight of clinical trials and ensure regulatory compliance. The application provides a centralized system for tracking Delegation of Authority (DoA) and mandatory protocol attestations. GCP Tracker is designed to meet 21 CFR Part 11 requirements, providing secure digital signatures and a robust audit trail for all administrative actions. Core Functional Features: Trial & Site Administration: Manage a global hierarchy of clinical trials, research sites, and user roles. Track active site counts and administrator assignments from a unified dashboard. Document Version Control: Upload protocol documents and establish the "current version" for the entire organization to prevent the use of outdated materials. Automated Attestation Workflows: Assign specific protocol versions to site users. The system tracks completion status and sends notifications for required signatures. 21 CFR Part 11 Compliant Signatures: Execute secure digital signatures on delegated protocols, ensuring that all attestations are legally binding and audit-ready. AI-Powered Protocol Queries: Utilize integrated AI to query uploaded protocol documents and receive answers with direct source citations from the text. Compliance & Security: Designed for high-stakes clinical environments, GCP Tracker ensures that every delegation and attestation is recorded with a timestamp and unique user identification. This minimizes the risk of compliance gaps during trial audits and simplifies the management of complex, multi-site studies.