Scope

This documentation covers the full lifecycle of the DHP, providing clinical trial professionals with detailed guidance on system architecture, installation, configuration, and effective use of the tool. It includes the following sections:

• System Architecture: A detailed overview of the DHP’s components and modules, supported by an architecture diagram, database schema, and descriptions of relationships between components, services, and controllers.

• Installation Guide: Step-by-step instructions for deploying the DHP in both server and local environments. This guide includes prerequisites, installation steps, database setup, and environment configuration.

• Configuration: Instructions on setting up essential configurations, such as authentication, application properties, database connections, master admin settings, and APIs.

• User Guide: A comprehensive manual for end users, covering topics like getting started with template spreadsheets, loading and visualising data, managing user roles and permissions, step-by-step usage, troubleshooting, and error handling.

• Maintenance and Support: Information on known issues, workarounds, and contact details for support.

• Appendix: Additional resources, including a glossary, references, and a FAQ section.

By providing structured and detailed information, this documentation equips users to make full use of the DHP for improved management and analysis of protocol deviations in clinical trials, ultimately supporting better data quality, patient safety, and trial outcomes.