eConsent for Oncology Trials: Managing Complex Consent at Scale

Informed consent in oncology is one of the most consequential interactions in the trial process. Oncology patients are often making decisions under significant stress, with limited time and high stakes. Protocols are complex, risks are real, and the consent document itself can run to dozens of pages. Paper-based consent processes are not built for this environment.

Sitero’s eConsent module, part of the Mentor eClinical platform, is designed to support the specific demands of oncology consent — complex documents, ongoing re-consent requirements, and sites managing high patient acuity.

The Re-Consent Challenge in Oncology

Oncology informed consent is not a one-time event. Protocol amendments are common, and each substantive change requires re-consent of enrolled patients. In a trial with frequent amendments — which is typical in early-phase and adaptive designs — managing re-consent across multiple sites and patient time zones becomes a significant operational burden under a paper process.

eConsent resolves this by enabling remote consent and re-consent, version-controlled documents, and a complete audit trail of who consented to what and when. Sites receive updated consent forms instantly when amendments are approved, rather than waiting for physical document distribution.

Supporting Complex Protocols

Long, complex consent documents benefit from multimedia support — visual aids, video explanations, and comprehension checks that help patients genuinely understand what they are agreeing to. Sitero’s eConsent platform supports multimedia integration, which is particularly valuable in oncology where patients are processing difficult information about experimental treatments, risks, and alternatives.

Audit Trail and Regulatory Compliance

Consent documentation is subject to GCP inspection and regulatory review. Every interaction with the eConsent platform — including the patient’s review, comprehension check responses, signature, and any re-consent events — is logged with a complete audit trail. This reduces the risk of consent-related findings at inspection, which are among the most common GCP deficiencies cited by FDA and EMA.

Integration with Site Workflows

For sites using Sitero’s EDC and RTSM, eConsent is part of the same integrated platform. A consented patient flows directly into the enrollment and randomization workflow without manual data transfer, reducing the administrative burden that Sitero’s oncology programs have seen decrease by 54% at the site level.