⎯⎯⎯  Captivate VDC: eConsent

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Captivate®
VDC: eConsent

Flexible, Web-Based Electronic Informed Consent for Modern Clinical Studies

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Product Overview

Deliver flexible, multimedia consent experiences with complete tracking, documentation, and seamless integration across the Captivate platform.

Secure & Participant-Centric eConsent

Captivate VDC eConsent is a secure, participant-centric electronic informed consent solution designed to streamline the consent experience while maintaining rigorous compliance and audit readiness.

Flexible & Comprehensive Tracking

Built for sponsors, CROs, and clinical data managers, Captivate VDC eConsent supports flexible presentation of consent materials, robust documentation of participant decisions, and integration with the Captivate platform to unify consent and clinical data.

Responsive Web-Based Interface

Captivate VDC eConsent is delivered through a responsive web interface that works across desktops, tablets, and mobile devices, reducing technical friction for participants and study teams alike.

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Structured Consent Experiences That Reflect Your Protocol

Captivate VDC eConsent enables study teams to design electronic informed consent materials that reflect their protocol, study population, and regulatory requirements.

1

Rich Content Support

Support for rich content including embedded video, images, and formatted text

2

Staged Consent

Configurable staged consent and consent grouping for complex protocols

3

Multi-Language Support

Multi-language support for global study populations

4

Comprehension Checks

Inline comprehension checks and dynamic content based on participant responses

5

Device-Agnostic

Responsive web interface accessible from desktop, tablet, and smartphone.

6

Pause & Resume

Ability to pause and resume consent flows without losing context for participants.

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Participant-Friendly Consent That Drives Understanding

Captivate VDC eConsent is designed to support participant engagement and comprehension at every stage of the consent process.

Simple Navigation

Simple navigation and clear presentation of consent elements

Accessibility Support

Built-in accessibility support for diverse participant needs

Resume Without Losing Progress

Ability to pause and resume consent flows without losing context

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Web-Based and Device-Agnostic Access

Participants can review and sign consent forms from their own devices without requiring a native application. The interface adapts to screen size and device type while preserving security and accessibility.

Responsive web interface accessible from desktop, tablet, and smartphone

Secure, role-appropriate access for participants and site staff

Support for in-clinic, remote, and hybrid consent workflows

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Secure Documentation
And Auditability

Ensuring a complete, accurate, and compliant record of consent interactions is central to Captivate VDC eConsent.

1

Complete Audit Trails

Complete audit trails of consent presentation and decisions

2

Time-Stamped Signatures

Time-stamped eSignatures aligned with applicable regulations

3

Secure Storage

Secure storage of signed consent documents alongside study data

4

Re-Consent Support

Support for re-consent and version tracking for amended consent forms

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Unified Consent Data with the Captivate Clinical Data Platform

Captivate VDC eConsent is fully integrated with Captivate EDC and other VDC modules, supporting
unified workflows and data visibility for study teams.

Centralized Status

Centralized access to consent status within Captivate study dashboards

Shared Audit Trails

Shared audit trails for consent and clinical data events

Unified Data review

Consistent data availability for review, monitoring, and reporting

Consent Metadata

Simplified downstream exports that include consent metadata

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A Practical Alternative to
Legacy Consent Models

Captivate VDC eConsent avoids the limitations of paper-based and rigid platform consent
approaches.

Engaging Workflows

More flexible and engaging than static PDF or paper workflows

Integrated & Traceable

More integrated and traceable than standalone eConsent tools

Scalable Design

Designed to scale from single-site studies to global, multi-phase programs

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Security, Compliance, and Inspection Readiness

Captivate VDC eConsent is built to meet global regulatory and privacy expectations while supporting audit and inspection readiness without operational complexity.

Compliance with 21 CFR Part 11, Annex 11, GDPR, and applicable privacy regulations

Secure delivery and storage of consent materials and signatures

Role-based access controls and detailed access logs

PHI and PII protections aligned with HIPAA and related standards

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Who Uses Captivate VDC eConsent

Captivate VDC eConsent is used by sponsors, CROs, academic research organizations, and medical device and diagnostics companies that require compliant, participant-friendly electronic consent solutions.

Interventional clinical trials
Hybrid and fully decentralized studies
Longitudinal observational research requiring re-consent
Studies with multimedia or staged consent requirements
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Why Study Teams Choose Captivate
VDC eConsent
1

Flexible Configuration

Flexible configuration that supports complex consent requirements

2

Participant-Centric

Participant-centric experiences that enhance understanding

3

Unified Data

Unified consent and clinical data for streamlined workflows

4

Built-in Compliance

Built-in compliance and inspection readiness

5

Device-Agnostic

Secure, device-agnostic access for global study populations

Ready to Learn More?

Discover how Captivate can support your clinical research needs. Our team is here to answer questions and show you what’s possible.