What is eConsent software?

eConsent software, also known as electronic informed consent software, allows patients and clinical trial participants to review information, ask questions, and provide informed consent digitally.

Traditional consent processes often rely on lengthy paper forms and conversations during appointments or study visits. With eConsent, individuals can review information at their own pace, revisit sections they don’t understand, and come prepared to discuss their questions with their healthcare provider or research team.

5thPort goes beyond digitizing consent forms to support meaningful informed consent. Our eConsent software combines interactive education, comprehension checks, and electronic signatures to help individuals understand what they’re consenting to. At the same time, automated audit trails, consent version tracking, and audit-ready documentation help healthcare providers and research organizations manage consent processes and support regulatory compliance.

Who is 5thPort’s eConsent software for?

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Healthcare Providers

Impact of AI Avatars on Patient Health Education

Hospitals, health systems, and specialty practices (like radiation oncology) can use 5thPort to educate patients about procedures, treatments, risks, and benefits before obtaining informed consent. Patients can review information at their own pace, while care teams gain greater visibility into patient comprehension and consent readiness.

Sponsors & CROs

Enhanced documentation for decentralized clinical trials with 5thPort

Clinical trial sponsors, contract research organizations (CROs), and research sites can use 5thPort to manage participant education, electronic informed consent, re-consent, and consent documentation across studies and sites. Remote, hybrid, and in-person workflows support different study designs and participant needs.

How does 5thPort’s eConsent software work?

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1. Send Consent Forms Digitally

Deliver personalized engagement plans through email or SMS. Patients and clinical trial participants simply click a secure link to access all their consent forms in one place, using any web browser. No app downloads required. They can review documents at their own pace, from wherever they choose.

2. Automate Reminders Before Appointments

Keep patients and participants on track with automated email and SMS reminders to complete their forms before appointments or study visits. This reduces time spent on paperwork during visits and gives providers more time for meaningful informed consent conversations, questions, and clinical discussions.

3. Customize Forms and Address Questions

5thPort can build and digitize your consent forms, including checkboxes, multiple-choice questions, comment fields, and other interactive elements. Patients review forms section by section, flag information they don’t understand, and submit questions or comments directly to their care or research team for follow-up.

4. Capture Electronic Signatures

Once questions have been addressed, patients and participants can provide electronic signatures to document their consent. 5thPort also supports legally authorized representative (LAR) signatures for individuals who require an authorized decision-maker, including eligible minors and adults who lack the capacity to consent.

5. Manage Consent Versions and Re-Consent

When consent forms or study protocols change, 5thPort supports near real-time updates, version control, and re-consent workflows. This helps ensure patients and participants receive the latest applicable consent information while organizations maintain a record of previous versions.

6. Generate Audit-Ready Documentation

5thPort automatically captures date- and time-stamped consent activities in its proprietary One-Touch Compliance Report. Healthcare providers and research teams can review consent records, track activities, and access documentation that supports regulatory compliance and audit preparation.

eConsent Software Features & Capabilities

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Patient Education & Comprehension

Leverage a smart informed eConsent process with multimedia patient education and teach-back to create meaningful informed consent processes.

EHR, EMR & CTMS Integrations

FHIR and integration with existing healthcare and clinical research systems.

Accessible Consent

Multiple languages (5thPort supports 80+ languages, even those read from R->L), has browser-based access, and no app downloads.

Customizable Consent Forms

5thPort supports the creation of interactive forms, checkboxes, comments, and multiple-choice questions to name a few.

LAR Support

eSignatures for patients, participants, and legally authorized representatives – especially when it comes to the consenting process involving minors or those unable to grant consent of their own.

Version Control & Re-Consent

Updated forms, ICF version tracking, and near real-time re-consent.

Security & Audit-Ready Compliance

HIPAA, 21 CFR Part 11, audit trails, and our proprietary One-Touch Compliance Reporting can track who touched which section of different consent forms. Especially comes in handy during IRB audits.

User Management & Access Management

Role-based permissions for providers, investigators, coordinators, and administrators. These include Patients, Caregivers/Guardians, Study Administrators, Site Administrators, Investigators, Monitors, and Read-Only Users.

Stay Audit-Ready with One-Touch Compliance Reporting

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The convenient One Touch Compliance (OTC) Report digitally documents every action taken by clinical trial participants and staff during the patient education and eConsenting process – including time and date stamps, as well as, the staff who completed said action. 5thPort’s eConsent software also ensures seamless version control and efficient re-consenting, so patients always receive the most up-to-date information while maintaining full regulatory compliance.

What does this mean for you?

1. Digital documentation at your fingertips
2. No stress compliance with internal or external consent audit requests
3. Solid risk mitigation

We’re creating a new standard of care. Come join the digital revolution.