CRF Based Qualification

Overview

The Case Report Form Qualification Engine is designed to help researchers create and manage inclusion and exclusion criteria for clinical studies. It features a dynamic logic tree, modular side panels, and customizable operators, allowing for flexible rule creation and automated data source generation.

Problem

Designing complex eligibility criteria for clinical studies can be error-prone and time-consuming, especially when managing various data sources and ensuring that all rules are correctly linked. Researchers need an intuitive, automated way to define and adjust qualification criteria, with the flexibility to handle changing requirements.

Approach

Logic Tree for Inclusion/Exclusion Criteria

The first step in building qualification criteria is the logic tree. Researchers can add multiple inclusion/exclusion (IE) criteria using AND, OR, or NONE logic, depending on the conditions. New criteria can be added at any point in the tree, allowing for flexibility in building the eligibility rules. The tree can grow dynamically, enabling researchers to design complex qualification structures.

Sidebar Criteria Configuration

Once new criteria are added to the tree, a sidebar opens with a dropdown of available options, organized under categories like demographics, medical, study-related, and survey-based (ePRO). Users select from these predefined fields (such as age, condition, or severity) and the sidebar then surfaces the relevant operators and inputs based on the selection.

Criteria Operators for Rule Configuration

Each item selected in the sidebar is then configured with criteria operators, which define the specific rules for the qualification. For example, if age is selected, the user can specify if the person must be greater than 18, less than 65, or meet other criteria. The criteria operators provide further flexibility, allowing researchers to fine-tune the logic by specifying timeframe, number, concept, or other conditions.

Impact

This Qualification Engine significantly simplified the process of building and managing complex clinical study eligibility rules. By offering a dynamic logic tree, modular sidebar configuration, and customizable operators, the system saved time, and ensured compliance with study protocols.