eConsent

Digital informed consent with customizable workflows, multimedia support, and multilingual options for clinical trials.

Overview

TrialStat eConsent is an electronic informed consent module built into the TrialStat EDC platform, designed to address trial enrollment and protocol compliance challenges for Sponsors and CROs. It supports both clinic-based and remote (decentralized) consent processes, and is accessible on any device type or size through an HTML5-based interface.

The module offers a customizable workflow with content templates, multimedia capabilities, and multilingual options, allowing study teams to create an interactive consent experience for trial participants. It supports mixed paper and eConsent processes, giving Trial Managers visibility into which participants have started or completed the consent process.

Key Features

Fully integrated with TrialStat EDC, making eConsent data immediately available within the study environment
Customizable consent forms with versioning support, enabling straightforward implementation of updated consent documentation
Mixed media support including images, video, audio, and native language options to improve participant comprehension
Web-based configuration and management through the same Study Designer interface used for other EDC functions
API-based interoperability, allowing the eConsent module to integrate with other EDC platforms that support such connections
HTML5-based design, compatible with any device type or screen size for use in clinic or at home

Compliance and Security

21 CFR Part 11 compliant
HIPAA compliant
GDPR compliant
Encryption applied to data both in transit and at rest

Reported Benefits

Improved protocol compliance
Reduced patient dropouts
Faster patient enrollment
Reduced enrollment costs
Streamlined consent status tracking and management across different sites
Support for decentralized clinical trials

TrialStat eConsent is configured through the TrialStat web-based Study Designer system, using a consistent interface familiar to study designers. The module is part of the broader TrialStat EDC suite, which also includes ePRO/eCOA, randomization/IWRS, pharmacovigilance, medical coding, and regulatory compliance functionality.