ELECTRONIC INFORMED CONSENT

DataRiver has developed the regulatory-compliant and patient-friendly “My Health eConsent”tool, for the management of informed consents in clinical trials on drugs and medical devices, compatible with all eCRF platforms.

The “My Health eConsent” Tool can be manage by medical staff and patient via PC, tablet and smartphone.

The eConsent module allows to send remotely, illustrate and signing informed consents, ensuring a better patient comprehension and enable them to make conscious decisions regarding the participation in the clinical trial through the use of interactive multimedia components and obtain an higher retention rates.

The use of the eConsent tool allows to improve quality and efficiency of clinical trials, enhancing consent tracking management, and easing the administrative procedures for clinical centers and study teams.

My Health eConsent is GDPR compliant and validated (Computer System Validation) according to international standards and guidelines for clinical trials: ICH GCP, 21 CFR part 11.

Features

My Health eConsent allows to send remotely, illustrate and signing informed consents by medical staff and patient via PC, tablet and smartphone.

eConsent improve patient experience, providing more comprehensible clinical trial information through  sharing documents, videos, and an interactive communication channel that allows patient to ask clarification on specific topics with the medical staff.

eConsent allows to improve the tracking of the informed consent process and verify in real time consent status

The use of the eConsent Tool simplifies study startup and and standardizes processes across all clinical centers, speeding up administrative procedures for the sites

eConsent allows to manage informed consents, documents, videos and other documents shared with patients in multiple languages allowing the management of international clinical trials.

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