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Product Requirements Document
This document describes the functional scope of the Study Setup application — a web platform for PMG that digitizes and governs the clinical study setup process.
Study Setup captures study requirements into a version-controlled Study Model, manages the full lifecycle of study output documents (PSD, Lab Manual, KDF, POP, etc.), and synchronizes approved configuration with downstream systems including BSI, Infor, Smartsheet, and ZenQMS. LIMS queries Study Setup as a downstream consumer.
The recognized set of clinical document kinds — inputs such as SOW and Protocol, and outputs such as PSD, Lab Manual, KDF, and POP — is defined in Document Types. That page is the shared vocabulary referenced by the Ingestion, Templates, and Studies (Outputs) modules.
Each module page covers the relevant UI mockup, the core business entities, high-level use cases, important notes, and the domain events that flow from user and system actions.
The system is modeled as an event-driven domain. See Commands & Events for the concept behind the formal Command, Event, and Policy objects that the module Events tables draw on. See Cross-Artifact Verification for why consistency across inputs, the Study Model, outputs, and remote systems is a structural property of the architecture rather than a separate verification engine. See Tabular Export for the system-wide CSV export available from every list and table view. See Version Visibility Filtering for how draft/current/superseded versions are filtered (default: current only) across lists and search.
The document's revision history is tracked in the Changelog.
Modules
| Module | Description |
|---|---|
| Studies | Study registration, lifecycle management, checkpoints, changesets, verification, and readiness evaluation |
| Templates | Master document templates that drive artifact generation (PSD, Lab Manual, POP, KDF) |
| Document Review | Internal peer review, external sponsor review via Release Candidates, and document versioning/release |
| Provisioning | Release of approved study configuration to downstream systems (BSI, Infor, Smartsheet, LIMS) |
| Master Data | System-wide reference data across four categories: materials, sites, codelists, and sponsors |
| Audit Trail | Immutable audit trail of all significant actions across the system |
| Notifications | In-app alerts for actionable events: changeset reviews, approvals, and checkpoint updates |
| Search | Global cross-entity search across studies, changesets, reviews, inputs, artifacts, and materials |
| Access Control | Authentication, role-based access control, study-scoped permissions, and external reviewer access |
| Source Ingestion | Upload and extraction of source documents (SOW, Protocol) into the study model |
| Reporting | Readiness, verification, milestone, and audit reports across studies |
| Admin / Configuration | Django's built-in admin: System Admin CRUD over configuration and reference data |
| External Client Review Portal | Chrome-less, token-scoped client/sponsor review site (comments + approval), isolated from internal modules |
Source References
| Resource | Description |
|---|---|
mockup/SPEC.md | Canonical product behavior specification for the UI mockup |
docs/events/domains/ | Pydantic-encoded commands, events, and policies per bounded context |
mockup/src/ | Vue 3 + Vuetify prototype (http://localhost:3001) |