Captivate®. Accelerating Clinical Trials®

⎯⎯⎯  Captivate VDC: eConsent

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Enhance the Patient Experience

VDC eConsent automates the patient enrollment process and onboards patients directly into Captivate EDC, improving overall consent tracking management, reducing informed consent errors, and easing the administrative burden for sites and study teams.

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Simplified Consent
Without Compromising Compliance
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. Built for sponsors, CROs, and clinical data managers, it unifies consent and clinical data.

Flexible & Comprehensive Tracking

Designed for both simple and complex requirements, Captivate VDC eConsent supports multimedia presentation of information, staged consent flows, and comprehensive tracking of participant engagement and decisions throughout the process.

Responsive Web-Based Interface

Captivate VDC eConsent is delivered through a responsive web interface that works seamlessly across desktops, tablets, and mobile devices. This device-agnostic approach reduces technical friction for participants and study teams alike, ensuring a smooth consent journey.

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Structured Consent Experiences
Design electronic informed consent materials that reflect your protocol, study population, and regulatory requirements. Customizable presentation of consent materials for complex requirements.
1

Rich Content Support

Support for embedded video, images, and formatted text to present information clearly.

2

Staged Consent

Configurable staged consent and consent grouping for complex clinical protocols.

3

Multi-Language Support

Accommodate global study populations with comprehensive language support.

4

Comprehension Checks

Inline checks and dynamic content based on participant responses to ensure understanding.

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
Designed to support participant engagement and comprehension at every stage. Review and sign consent forms from your own device without requiring a native application.

No App Required

Secure, web-based access from any modern device

Simple Navigation

Clear presentation of consent elements and easy flow

Accessibility Support

Built-in support for diverse participant needs

Engagement Tracking

Comprehensive tracking of participant engagement and decisions

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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

Traceable logs of consent presentation and participant decisions.

2

Time-Stamped Signatures

eSignatures aligned with applicable regulations and time-stamped.

3

Secure Storage

Signed consent documents stored alongside study data securely.

4

Re-Consent Support

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

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Integration with the
Captivate Platform
Fully integrated with Captivate EDC and other VDC modules, supporting unified workflows and data visibility for study teams.

Centralized Status

Access to consent status within Captivate study dashboards

Shared Audit Trails

Consistent tracking 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
Captivate VDC eConsent avoids the limitations of paper-based and rigid platform approaches by offering a flexible solution.

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 to global, multi-phase programs.

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Security, Compliance And Readiness
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, and GDPR

Secure delivery and storage of consent materials and signatures

Role-based access controls and detailed access logs

PHI and PII protections aligned with HIPAA standards

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Who Uses Captivate VDC eConsent
Used by sponsors, CROs, academic research organizations, and medical device companies requiring compliant electronic consent solutions.
Interventional Clinical Trials
Hybrid & Decentralized Studies
Longitudinal Research
Multimedia Consent
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Why Study Teams
Choose Captivate
1

Flexible Configuration

Supports complex consent requirements

2

Participant-Centric

Experiences that enhance understanding

3

Unified Data

Unified consent and clinical data workflows

4

Built-in Compliance

Inspection readiness out of the box

5

Device-Agnostic

Secure 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.

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