study-setupDocumentation

Product Requirements ​

Functional scope of Study Setup — modules, domain events, and cross-artifact verification.

• Introduction — Overview of the platform and module index.

Concepts ​

• Document Types — Shared vocabulary for clinical document kinds.
• Commands & Events — Formal Command, Event, and Policy objects.
• Cross-Artifact Verification — Consistency across inputs, the Study Model, outputs, and remote systems.

Modules ​

• Studies — Registration, lifecycle, checkpoints, changesets, and readiness.
• Templates — Master document templates for artifact generation.
• Document Review — Internal and external review, versioning, and release.
• Provisioning — Release of approved configuration to downstream systems.
• Master Data — Materials, sites, codelists, and sponsors.
• Audit Trail — Immutable audit trail of significant actions.
• Notifications — In-app alerts for actionable events.
• Search — Global cross-entity search.
• Access Control — Authentication, RBAC, and external reviewer access.
• Source Ingestion — Upload and extraction of source documents.
• Reporting — Readiness, verification, milestone, and audit reports.

User Manual ​

End-user documentation for the application.

• Introduction — Getting started and using the product.

Development Guide ​

Architecture, deep dives, and vendored backend libraries for contributors.

Overview ​

• Architecture — Layout, local runtime, data model, and background tasks.

Deep dives ​

• Frontend — React 19, Vite, TanStack Router/Query, auth, and data fetching.
• Backend — Django + Ninja API, Allauth headless auth, Celery, and storage.
• Docs — How this VitePress site is built, configured, and run.
• Build & CI/CD — GitLab pipeline, Helm charts, and how to test the whole thing locally.

Libraries ​

Vendored packages under backend/lib/, documented from their READMEs.

• eventcore — Formal Commands and Events for Django apps — validated intentions, typed events, and subscriber hooks.
• tracker — Progress tracking for Celery workloads — stamped task groups and a Django Ninja API.
• uncouple — Typed configuration from environment variables with nesting, prefixes, and secure defaults.