fikreab-s/hact-ctms

HACT Clinical Trial Management System - Open-Source CTMS for Horn of Africa Clinical Trials # HACT Clinical Trial Management System (CTMS) An open-source Clinical Trial Management System built for the **Horn of Africa Clinical Trials (HACT)** organization. ## Overview The HACT CTMS is a composable, open-source platform designed to manage the full lifecycle of clinical research — from protocol design through data collection, safety monitoring, regulatory compliance, and final dataset export for statistical analysis. ## Architecture The system uses a **composable open-source stack**: | Component | Technology | Purpose | |-----------|-----------|---------| | EDC / Clinical Data | OpenClinica CE | eCRF design, data entry, queries, audit trail | | Custom Backend | Django + DRF | API gateway, orchestration, safety/regulatory/lab modules | | Custom Frontend | React + Vite | Unified SPA for dashboards and administration | | Identity & Access | Keycloak | SSO, OAuth2/OIDC, 2FA | | Operations | ERPNext | Site management, contracts, milestones | | Documents (eTMF) | Nextcloud | Regulatory document management | | Lab Information | SENAITE | Sample tracking, lab workflows | | Database | PostgreSQL | Primary data store | | Infrastructure | Docker Compose | Containerized deployment | ## Repository Structure ``` hact-ctms-dev/ ├── docs/ │ └── PRODUCT_REQUIREMENTS_DOCUMENT.md # Full PRD (start here) ├── backend/ # Django API (coming soon) ├── frontend/ # React SPA (coming soon) ├── infrastructure/ # Docker Compose, Nginx configs (coming soon) ├── database/ # SQL migrations and schema (coming soon) └── README.md ``` ## Getting Started ### Prerequisites - Docker & Docker Compose - Node.js 20+ (for frontend development) - Python 3.12+ (for backend development) - PostgreSQL 16+ (for local development) ### Documentation Start with the Product Requirements Document for the complete system specification. ## Key Features - **12-Step Clinical Trial …