Purpose

The purpose of this documentation is to provide clinical trial professionals with a complete guide to effectively using the DHP. This manual covers all aspects of the tool, including its development, architecture, installation, configuration, and day-to-day use. By following these guidelines, users will be equipped to categorise and manage protocol deviations accurately, leveraging the tool’s NLP capabilities to support data analysis and decision-making.

This documentation is designed not only to assist with setup and configuration but also to help users make the most of the DHP’s functionality. Through clear instructions and practical examples, it aims to support users in making timely interventions, improving data quality, and enhancing patient safety. Additionally, it outlines how insights gained from deviation data can be used to inform improvements for ongoing and future trials making sites more attractive to sponsors.