eConsent

Signant Health's SmartSignals® eConsent is a digital informed consent platform designed for clinical trial sponsors, sites, and study collaborators who need to ensure participant comprehension, maintain audit-ready documentation, and streamline the consent process at any scale. By replacing traditional paper consent forms with an engaging digital experience, the solution supports ethical clinical research and reduces the administrative burden associated with version control, re-consenting, and regulatory compliance.

eConsent is associated with improved participant comprehension compared to paper documents, and a common reason for early participant withdrawal is not fully understanding study requirements. Signant SmartSignals® eConsent addresses this directly by providing interactive, multimedia-rich content and comprehension checks, while eliminating the data ambiguities and audit findings that paper forms frequently introduce.

Core Benefits by Stakeholder

• Participants: The traditional paper consent form is transformed into an engaging digital experience that supports various learning styles and actively checks comprehension before consent is given.
• Sites and study collaborators: SmartSignals® eConsent can be deployed alongside Signant's eCOA, RTSM, and Patient Engagement solutions, eliminating the need for multiple devices and separate logins.
• Sponsors: An intuitive interface provides a real-time, interactive picture of study progress, while a complete audit trail minimises regulatory risks.

Key Platform Capabilities

• Improved comprehension: Delivers more engaging content and question-flagging features so participants better understand study requirements before signing.
• Elimination of audit findings: Unlike paper forms, the digital platform removes ambiguities and provides a fully transparent, traceable, time- and date-stamped consent process.
• Correct ICF version control: Automatically ensures that the most current Informed Consent Form (ICF) version is always in use, removing the risk of outdated forms being presented.
• Error-free re-consenting: Streamlines the re-consenting process to accommodate study amendments, whether completed at home or on site.
• Real-time monitoring and traceability: Date and time stamps combined with real-time monitoring improve compliance and provide full traceability throughout the study lifecycle.

eConsent Options

• PDF-Based eConsent: Imports and presents existing PDF versions of the ICF and enables electronic or digitised signature sign-off. Available remotely and during site visits, it includes ICF version control and re-consent process management. This option is ideal for simple studies, Phase I trials, and situations requiring rapid implementation.
• Interactive eConsent: The most advanced option, offering an engaging multimedia experience for participants. Features include embedded video and audio playback, comprehension tests, and the ability to flag content for focused discussion with the investigator. Self-service customers gain access to template libraries to accelerate ICF assembly and study build. Reporting dashboards provide insights to aid ICF revision, including identification of questioning hotspots where additional detail may be beneficial.

Study Types Supported

• Traditional, site-based eConsent studies
• Remote and at-home consent workflows
• On-site, virtual, and hybrid study designs
• Phase I through global Phase III studies
• Studies requiring rapid implementation or complex, multimedia-rich consent experiences

Service and Delivery Models

• Self-service model: Customers use their own existing infrastructure to develop unique consent forms and documentation, retaining complete control over the consent process.
• Project delivery services: Signant's experienced operational delivery team can manage the entire consent process on behalf of the sponsor or site.
• Design and consultancy services: Available to support teams operating in a self-service model who require additional guidance during ICF design and study build.

Signant SmartSignals® eConsent integrates with other solutions within the SmartSignals product suite — including eCOA, RTSM, and Patient Engagement — as well as with third-party eClinical systems, enabling centralised document management and seamless clinical data exchange across the trial ecosystem.