ePRO

DACIMA ePRO is an electronic Patient Reported Outcome software developed by Dacima Software that allows researchers and clinical study teams to build online surveys, forms, polls, quizzes, and questionnaires, or to use existing study forms. These forms are completed by patients online using any device, including tablets and smartphones, making it suitable for medical, health-related research, and post-marketing drug studies.

The platform is designed for clinical research environments and includes tools for survey management, patient communication, compliance tracking, and data reporting. It supports hybrid survey modes and integrates with scheduling and visit structures to automate form delivery at appropriate study timepoints.

ePRO Survey Manager Capabilities

• Tracks respondent survey completion and monitors survey status across participants
• Provides data extraction options and a query builder for creating custom reports and outputs
• Manages invitations, reminders, welcome messages, and other communication pages
• Supports hybrid survey delivery via email invitations, URL access, and manual entry of paper-based surveys
• Automatically tracks all survey types regardless of delivery method

Data Capture and Device Compatibility

• Supports self-completion data entry forms accessible from any device, including computers, tablets, and smartphones
• Integrates with the Scheduler module and visit structure to automatically send email reminders to subjects at the appropriate time
• Interviewers can activate forms for self-completion on a computer or tablet, or trigger an automatic email to the subject with an embedded link to the ePRO forms
• Participants can be invited via personalized email or SMS to complete forms at their convenience

Form Design and Logic

• Supports creation of simple questionnaires as well as complex follow-up questionnaire designs
• Dynamic form logic allows conditional branching: if a submitted response meets defined criteria, a different form is automatically loaded instead of the default
• Conditional dependencies can enable or disable fields, trigger pop-up messages, and change colors to guide respondents
• Questionnaires are highly customizable to accommodate varied study requirements

Status Tracking and Patient Management

• Status tracking and management features allow monitoring of questionnaire completion across study subjects
• Simplified ePRO interface is designed for easy data entry by study subjects
• Supports both interviewer-initiated and patient self-initiated form completion workflows

Reporting and Data Extraction

• Query builder allows extraction of data subsets and generation of aggregate and summary statistics reports
• Built-in reports section provides summary statistics, data dictionary generation, and data query reports
• Includes a SAS code generator that automatically writes SAS import format and label code

Compliance and Regulatory Standards

• Complies with FDA 21 CFR Part 11 requirements
• Adheres to Good Clinical Practices (GCP)
• Maintains a complete audit trail, supporting use in regulated clinical and post-marketing research contexts

DACIMA ePRO is part of the Dacima Software suite, which is a member of the EvidentIQ Group. The platform is available for trial with a guided session, and personalized demos can be arranged for teams with specific study requirements.