Medidata Consent

Informed consent shouldn’t slow studies down, but for many sites it still does. Dense documents overwhelm patients, disconnected tools burden teams, and valuable time is lost to manual workflows.

Medidata Consent supports everything from simple trials to complex, multi-arm pediatric studies, with flexible workflows that scale as protocols change.

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Simplify Informed Consent and Enrollment

Remove delays and added work in the consent process with a connected digital approach. Medidata Consent helps patients understand what participation entails while giving sites and sponsors real-time visibility and control as studies grow more complex.

Manage Signed Documents in One Place
Send Reminders and Monitor Assessments
Support Pediatric Assent with Adaptive Workflows
Enable Clinician-led Assent
Track Trends and Status across Sites
Provide Dedicated Patient Experience Helpdesk
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A New Standard for Consent

Faster Start-up

Launch Trials in Weeks, Not Months

Configure consent workflows to fit your study, without custom code.

From straightforward designs to multi-arm pediatric trials, teams can scale and adjust as requirements change.

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Resources


Explore deeper guidance and related materials.

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FAQ

Traditional paper consent creates a "foundational disconnect" when the rest of the trial journey is digital. While paper seems familiar, it introduces manual delays, transcription risks, and a fragmented experience. By moving to eConsent, you unify the workflow, ensuring that the first step of the patient journey matches the modern, digital standards of the rest of the trial.

Medidata Consent was designed with insights from the Medidata Site Tech Board to improve productivity. It removes administrative friction by operating as a unified part of Rave EDC, eCOA, and more. By replacing parallel paper workflows with automated version control, Consent ensures the right forms are always used while allowing site staff to manage their entire study within a single, streamlined ecosystem.

Absolutely. It is engineered for modern complexity, including pediatric assent (with specific age-cohort workflows), multi-arm trials, and re‑consenting scenarios. For global reach, it supports eIDAS-compliant signatures and offers a hybrid "paper-to-digital" upload feature for regions where wet-ink signatures are still required.

Unlike a static paper form, eConsent allows for multimedia content and pre-visit access to documents. Patients can review complex information at their own pace and engage in informed discussions with site staff before the consent visit, leading to a more empowered and "research-ready" participant.

Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.