eConsent

eConsent is a digital method for managing informed consent in clinical trials, replacing traditional paper forms with a streamlined, mobile-friendly experience. It allows participants to access, review, and sign consent forms electronically from any device, enhancing the enrollment process and supporting decentralized and hybrid trial models.

Participants can engage with multimedia content for better understanding and sign electronically, which strengthens regulatory compliance through built-in audit trails and version control. eConsent is integrated within the TrialKit platform, providing a seamless experience for sponsors and CROs while maintaining compliance with 21 CFR Part 11, HIPAA, and GDPR.

Features of TrialKit eConsent

• eConsent forms with links to video and PDF
• Study participant eSignature
• Handoff manager
• Quick view of consented participants
• PDF of consent report

TrialKit's eConsent software improves patient retention by offering clear explanations with educational hyperlinks, pop-up windows, photos, and videos. Patients receive copies of consent forms automatically, enhancing communication and transparency. The system allows patients to review documents at their convenience on any device, and they can complete informed consent on site with a clinician using handoff mode.

eConsent facilitates smoother global studies by allowing remote consent from virtually anywhere, with translations available in 16 languages. Customizable forms can be created using a drag-and-drop form builder, and automated email notifications keep all parties informed. Study teams have real-time access to consent data through web or mobile apps, with role-based permissions ensuring data security.

The eConsent process is intuitive and flexible, with participants receiving secure links to begin the consent process. Interactive consent experiences include videos and glossary terms, with comprehension checks to ensure understanding. Digital signatures are captured with secure authentication, and the system generates audit-ready digital records.

Benefits of eConsent

For Participants

• Easier access and comprehension of consent forms
• Multilingual options and multimedia aids
• Remote access and increased flexibility
• Improved trust and transparency

For The Study Team

• Faster enrollment and reduced drop-offs
• Audit-ready digital trails
• Reduced errors and improved compliance
• Time and cost savings

Compliance and Security Standards

• HIPAA and GDPR alignment
• Regulatory compliance for global studies
• Data encryption and access controls